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National Institute for Occupational Safety and Health (NIOSH)
National Personal Protective Technology Laboratory (NPPTL)
Conformity Verification and Standards Development Branch (CV&SDB)
The Standard Application Procedure
for the Approval of
Self-Contained Breathing Apparatus and
Chemical, Biological, Radiological, and Nuclear
Self-Contained Breathing Apparatus
Under 42 CFR Part 84
Revised: August 4, 2022
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Table of Contents
Introduction .................................................................................................................................................................. 5
Section 1 General Information for Self-Contained Breathing Apparatus or CBRN SCBA ....................................... 6
1.1 Getting Started............................................................................................................................................. 6
1.1.1 Who May Apply ................................................................................................................................. 6
1.1.2 Approval ............................................................................................................................................. 6
1.1.3 Applicants Without a Three Character Manufacturer’s Code .......................................................... 6
1.1.4 Applicants Without a NIOSH Approval ............................................................................................. 6
1.1.5 Where to Find the Standard Application Form ................................................................................. 7
1.1.6 Submitting the Application ............................................................................................................... 7
1.1.7 Documents to Submit with the Application ..................................................................................... 7
1.1.8 Submitting the Application and Associated Documents ................................................................... 7
1.1.9 Submitting Test Samples (Hardware) ............................................................................................... 8
1.2 Types of Applications ................................................................................................................................... 8
1.2.1 New Approval Application ................................................................................................................. 8
1.2.2 Extensions of Approval Application .................................................................................................. 9
1.2.3 Quality Assurance Approval Application ........................................................................................ 13
1.2.4 Resubmission of Applications ......................................................................................................... 14
1.2.5 Amended Application ...................................................................................................................... 14
1.2.6 Correlation Testing Only Application .............................................................................................. 14
1.3 Approval Label Protections and Cautions and Limitations for SCBA and CBRN SCBA ............................. 15
Section 2 Specific Instructions for Preparing a SCBA or CBRN SCBA Application Package ................................... 16
Section 3 Supplemental Information for Preparing a SCBA or CBRN SCBA Application ..................................... ..26
3.1 Quality Assurance Documentation ........................................................................................................... 26
3.2 Quality Assurance Manual......................................................................................................................... 26
3.3 Product Quality Control Plan and Documentation ................................................................................... 27
3.4 Fees ............................................................................................................................................................ 28
3.5 Combination Supplied-Air Respirators and SCBA, SCBA, or CBRN SCBA Test Fees ................................. 29
3.6 Annual (Fixed) Certification (Approval) Fees ............................................................................................ 30
3.7 Pay.Gov Instructions .................................................................................................................................. 32
3.8 Drawings for a Self-Contained Breathing Apparatus or CBRN Self-Contained Breathing Apparatus .... 34
3.8.1 Exploded-View Drawing and Major Subassembly Drawing for a SCBA or a CBRN SCBA .............. 34
3.8.2 Example of an Exploded-View Drawing for an SCBA or a CBRN SCBA ........................................... 35
3.8.3 Major Subassembly Drawings for a SCBA or a CBRN SCBA ............................................................ 35
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3.8.4 Material Specifications on Drawings for a SCBA or a CBRN SCBA.................................................. 36
3.9 Component Vendors .................................................................................................................................. 36
3.10 Assembly Matrix ...................................................................................................................................... 36
3.11 Approval Labels and Private Labels ......................................................................................................... 38
3.12 List of NIOSH Cautions and Limitations for SCBA or CBRN SCBA ........................................................... 38
3.13 Private Labeling Versus Private Packaging ............................................................................................. 39
3.14 User Instructions ...................................................................................................................................... 40
3.15 Packaging Art Work and Carton Design .................................................................................................. 41
3.16 Summary of Related Documents ............................................................................................................. 42
3.17 File Naming Conventions ......................................................................................................................... 43
Section 4 Approvals and Denials ............................................................................................................................ 45
4.1 Approval Documentation .......................................................................................................................... 45
4.2 Denial Documentation ............................................................................................................................... 45
4.3 Denial Prior to Assignment of a Task Number .......................................................................................... 45
4.4 Denial of a Project Undergoing NIOSH Evaluation ................................................................................... 46
4.5 Respirator Certification (Approval) Program Decision Review Process ................................................... 46
Section 5 Test Selection Guide for Self-Contained Breathing Apparatus and CBRN SCBA .................................. 47
Section 6 Checklists for Self-Contained Breathing Apparatus or CBRN SCBA ....................................................... 59
6.1 NIOSH Respirator Application Checklist .................................................................................................... 59
6.2 Exploded-View Drawing Checklist for a Self-Contained Breathing Apparatus or CBRN SCBA ................ 61
6.3 Major Subassemblies Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA .................. 62
6.4 Self-Contained Breathing Apparatus or CBRN Self-Contained Breathing Apparatus .............................. 63
6.5 Supplied-Air Respirator ............................................................................................................................. 65
6.6 Private Label Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA ............................... 66
6.7 Assembly Matrix Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA ........................ 67
Section 7 - Document Examples for a Self-Contained Breathing Apparatus or a CBRN SCBA ................................. 68
7.1 Example of a Product Quality Plan for a Self-Contained Breathing Apparatus or a CBRN SCBA ............ 68
7.2 Example of an Assembly Matrix for a Self-Contained Breathing Apparatus ........................................... 70
7.3 Example of an Assembly Matrix for a CBRN Self-Contained Breating Apparatus ................................... 71
7.4 Example of an Exploded-View Drawing for a SCBA or a CBRN SCBA ....................................................... 72
7.5 Example of an Approval Label for a Self-Contained Breathing Apparatus .............................................. 73
7.6 Example of an Approval Label for a CBRN Self-Contained Breathing Apparatus .................................... ....74
7.
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Example of an Approval Label for a SCBA and Combination SCBA/SAR ................................................ ......76
7.8 Example of an Approval Label for a SCBA Harness ................................................................................. ......78
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7.9 Example Approval Label for CBRN Self-Contained Breathing Apparatus Harness .................................. 79
S
ection 8 Label Format and Guidance .................................................................................................................... 80
Appendix ..................................................................................................................................................................... 81
Letter to All Respirator Manufacturers ...................................................................................................................... 81
Definitions ................................................................................................................................................................... 92
Acronyms ...................................................................................................................................................................100
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Introduction
This document is a revision to the NIOSH Standard Application Procedure for the Approval of Respirators
dated August 2015. It is intended to add clarity to the approval process under Title 42, Code of Federal
Regulations (CFR) Part 84 (also known as 42 CFR Part 84). It is recommended that applicants review the
entire document before submitting a respirator for approval.
This Standard Application Procedure (SAP) correlates with version 8 of the Standard Application Form
(SAF).
NPPTL has developed individual instructions for each class of respirator. The information in this document
pertain to the approval of Self-Contained Breathing Apparatus (SCBA) and Chemical, Biological,
Radiological, and Nuclear Self-Contained Breathing Apparatus (CBRN SCBA). Please see the appropriate
application for the type of respirator being submitted.
This standard application procedure should be used for the following classes of respirators:
Schedule 13F
• Self-Contained Breathing Apparatus for Entry or Escape, Demand or Pressure-Demand, Open-
Circuit or Closed-Circuit;
• Self-Contained Self-Rescuers; Combination Escape Only Self-Contained Breathing
Apparatus/Supplied-Air Respirator; and
• Combination Self-Contained Breathing Apparatus and Supplied-Air Respirator.
Schedule 13F-CBRN
• Self-Contained Breathing Apparatus for Entry or Escape, Pressure-Demand, Open-Circuit with
Chemical, Biological, Radiological, and Nuclear Protection for Use in Firefighting and in
Conjunction with Safety Equipment Institute and the National Fire Protection Association.
Compliance with all instructions is essential for efficient processing of an application.
The information in Section 2 of this document provides specific step-by-step instructions to prepare an
application for a Self-Contained Breathing Apparatus or Chemical, Biological, Radiological, and Nuclear
Self-Contained Breathing Apparatus. The paragraphs are numbered to correspond with the sections of
version 8 of the standard application form (SAF).
Additional guidance and information related to SCBAs and CBRN SCBAs is included in the sections that
follow and should be used as reference.
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Section 1 General Information for Self-Contained Breathing
Apparatus or CBRN Self-Contained Breathing
Apparatus
Instructions for Preparing an Application for a Self-Contained Breathing Apparatus
(SCBA) or a CBRN Self-Contained Breathing Apparatus (CBRN SCBA) (13F or 13F-CBRN
Approvals)
This guide applies strictly to SCBAs and CBRN SCBAs. Please see the appropriate
application and instructions for submitting an application for a different class of
respirators.
1.1 Getting Started
1.1.1 Who May Apply
An individual, partnership, company, corporation, association, or other organization that designs,
manufactures, assembles, or controls the assembly of a respirator may apply to NIOSH to become an
approval holder (42 CFR Section 84.2). An organization may appoint an authorized representative to
complete and submit the Standard Application Form (SAF) to NIOSH.
1.
1.2 Approval
Approval is issued once NIOSH determines the product conforms to the requirements of 42 CFR Part 84.
1.1.3 Applicants Without a Three Character Manufacturer’s Code
A prospective approval holder that has not applied for a NIOSH-Assigned three character manufacturer’s
code will need to complete the Prospective Approval Holder Form and return it to the NIOSH NPPTL
Records Room. To obtain the form, contact the NIOSH NPPTL Records Room at recordsroom@cdc.gov
or (412) 386-4000.
1.1.4 Applicants Without a NIOSH Approval
Prospective approval holders, without a NIOSH-Approved respirator, who have received a three
character manufacturer’s code, may submit an initial application for a single new respirator along with a
signed and approved company Quality Assurance (QA) Manual.
For prospective approval holders, once the application is accepted, reviewed, the respirator is tested,
and a final review is successfully performed, a site qualification visit will be scheduled and conducted
prior to the issuance of any approval. Please see the fee schedules for the cost of the site qualification.
Other applications may be submitted with the initial application. However, subsequent applications will
not be reviewed until the site qualification is completed and the initial application is approved.
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The site qualification visit is only performed for new applicants (those without a NIOSH approval).
Approval holders with joint NIOSH and Mine Safety and Health Administration (MSHA) approval have
routine site audits conducted annually. NIOSH performs routine site audits for all approval holders
every two years.
1.
1.5 Where to Find the Standard Application Form
The standard application form, version 7 can be downloaded from the NIOSH NPPTL website. SAF
versions 8 and 9 may be requested from the NPPTL Records Room once the manufacturer’s code is
issued.
1.1.6 Submitting the Application
Applications should be submitted on CD-R or DVD-R electronic media. Neither rewritable CDs nor thumb
drives will be accepted. Due to computer security policies, NIOSH cannot accept thumb drives.
Only one application per CD-R or DVD-R will be accepted. CD-Rs and DVD-Rs will be destroyed once the
project is closed, unless a prepaid shipping label is sent with the media.
Compressed or “zip” files are recommended for applications submitted via email. Applicants that
choose to email the attachments to NIOSH at recordsroom@cdc.gov risk having the information
stripped by mail routers.
Note: For part 84 SCBA applications, please use a standard Applicant-Assigned Reference Number
(AAR#). For the CBRN SCBA application, use the same AAR# but add the CBRN on the end. Example:
Part 84 application AAR#: LWN001 CBRN SCBA Application AAR#: LWN001CBRN
1.1.7 Documents to Submit with the Application
Checklists specific to the type of application being completed are included in Section 6. Fee schedules
are included in Section 3. Tests required for the specific respirator type are included in Section 5.
Documents must be named in accordance with the prescribed naming convention, using an acceptable
software package.
1.1.8 Submitting the Application and Associated Documents
The CD-R or DVD-R with the completed application form and associated documents, including the
application fee check or pay.gov receipt, must be sent to:
NIOSH NPPTL
CV&SDB, Records Room
626 Cochrans Mill Road
Pittsburgh, PA 15236
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1.1.9 Submitting Test Samples (Hardware)
NIOSH NPPTL
CV&SDB, Evaluation and Testing
626 Cochrans Mill Road
Pittsburgh, PA 15236
All boxes containing test samples (hardware) must be marked with the AAR# and include a packing
slip.
Test samples (hardware) submitted for a series of applications must be identified for each project which
it is to be used. For example, a Self-Contained Breathing Apparatus (SCBA) that is to be used on three
projects, because the respirator has three different pressure reducers, must have all three Applicant-
Assigned Reference Numbers (AAR#s) on the packaging. If there are multiple containers, each container
must be labeled with all the appropriate information.
All sample components must be identified and labeled with their corresponding part numbers as listed
on the assembly matrix.
If test samples (hardware) is being sent to NIOSH for the testing of multiple projects, please include this
information in the first application where testing will be performed and label the test samples
(hardware) package with each AAR#.
1.2 Types of Applications
The types of applications include: New Approval Application, Extension of Approval Application, Quality
Assurance Approval Application, Amended Application, Correlation Testing Only Application,
Resubmission of New Approval Application, and Resubmission of Extension of Approval Application.
If there is any doubt about the appropriate type of application to submit, call the NIOSH NPPTL
Conformity Verification and Standards Development Branch (CV&SDB) at (412) 386-4000.
Several screens in the Standard Application Form for New Approval Applications and Extension of
Approval Applications identify the data fields that will be entered directly into the NIOSH Certified
Equipment List (CEL). The product description should be short and succinct for an accurate reporting of
the respirator in the CEL.
New Approval Applications and Extension of Approval Applications must contain or reference the
following items as described in detail in Section 2 and 3 of this SAP.
1.
2.1 New Approval Application
• Used for new design, substantially different design, or when a different type or level of
protection requested for an existing NIOSH-Approved respirator.
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• NIOSH assigns a new testing and certification (TC) number for each new respirator system design
that is approved.
• An application may be submitted for only one basic new respirator design per application.
• Applications containing more than one design will be denied.
o For example, if an applicant submits a new respirator with and without an air-line
connection that uses the same regulator assembly, NIOSH requires two separate
applications resulting in two new approvals because each arrangement represents a
separate design and limitations for different uses.
• New Approval Applications must contain or reference the following items as described in detail
in Sections 2 and 3 of this SAP.
• NIOSH Standard Application Form.
• Pretest Data.
• Simplified Drawings.
• Assembly Matrix.
• Draft Approval Label(s).
• Quality Assurance Manual (Manual to be submitted separately as QA application after first
approval).
• Product Quality Control Plan.
o Classification of Defects Document.
o Sampling Plan.
• Application Fee, $200.
• User Instructions.
• Test Samples (Hardware).
1.
2.2 Extensions of Approval Application
Submitted when:
• A critical or major characteristic affecting performance is altered on a previously approved
respirator.
• A critical or major characteristic affecting design (including Quality Assurance provisions) is
altered on a previously approved respirator.
• A new accessory is added to a previously approved respirator.
• A change is made to an approval label, assembly matrix, User Instructions, or drawings.
• A product is made obsolete.
• The approval holder wants to add multiple components to one previously approved SCBA.
• All the TC numbers on a given assembly matrix apply to the extension. The assembly matrix may
be referenced in lieu of listing the individual TC numbers.
• All TC numbers affected must be listed in the “Reason for Application.”
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Additional Components Previously Approved SCBA
• An approval holder wants to add a component multiple previously approved respirators.
Component Previously Approved SCBAs
The approval holder,
company ABC, requests a
single accessory be added
to multiple previously
approved SCBAs.
TC-13F-1234
TC-13F-2345
TC-13F-1357
The approval holder,
company ABC, requests the
addition of multiple
accessories to a previously
approved SCBA described in
TC-13F-xxxx
Radio Interface
Regulator Docking Bracket
Spectacle Kit
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Changes to minor characteristics not affecting performance or design which are not documented in the
NIOSH approval records do not have to be submitted to NIOSH. A minor characteristic is an attribute,
such as the size of the belt loops on the harness. Approval holders are responsible for keeping all
changes to minor characteristics on file and available for review at the request of NIOSH.
This includes any minor changes to any document that is part of the approval record. These changes
should be submitted for an extension of approval at your earliest convenience. Note, documents not up-
to-date in the NIOSH record could be identified during a site audit and resulting in a non-conformance.
If the type or level of protection changes, a New Approval Application must be submitted. For example,
an SCBA with a 4500 pressure cylinder and 30 minute service time may be submitted and approved. The
subsequent submission of the same SCBA with the same pressure cylinder but with a 45 minute service
time would be considered to be a new ‘Type,’ requiring a New Approval Application and a different TC
number being issued.
In addition, a New Approval Application is required and a different TC number will be issued for
additions of a new respirator arrangement to a respirator family, model, or series such as a new
facepiece on an existing SCBA model.
Extension of Approval Applications must contain the following items or reference as described in detail
in Sections 2 and 3 of this SAP.
• NIOSH Standard Application Form.
• Pretest Data.
• Simplified Drawings.
• Assembly Matrix.
• Draft Approval Label(s).
• Product Quality Control Plan.
o Classification of Defects Document.
o Sampling Plan.
• Application Fee, $200.
• User Instructions.
• Test Samples (Hardware).
In the “Reason for Application”: Describe exactly and completely the change(s) or addition(s) to the
approved respirator(s) and how the change(s) will affect the previously approved respirator(s). Provide
a succinct description on the previously approved respirator(s). For example, "An Extension of Approval
to allow our ‘xyz’ alternate second stage regulator to our SCBA models 123, 456, and 789. No other
respirators are affected. This request is for use of an alternate second stage regulator only." The
Extension of Approval Application request must clearly indicate:
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1. The affected respirator(s) by name, TC number, and part number. If multiple approvals are
affected, the assembly matrix or matrices that contain these approvals may be listed in lieu of
the TC numbers.
2. Complete details of the change(s) or addition(s).
3. Related documentation that has changed since the last approval (assembly matrix, inspection
procedures, simplified drawings, draft approval label, product quality control plan, User
Instruction).
Example of a Well-Written Reason for Extension of Approval Application:
Provides the model number, TC number, type of respirator, and what is being requested in a
very descriptive manner. In this example, the request is to allow four new air-line/manifold
pneumatic components, a new supplement to the User Instructions, and to add additional
hose/handwheel assemblies. The details are provided.
This Extension of Approval Application is for a modification of approvals TC-13F-123, TC-13F-456,
TC-13F-789, and TC-13F-234 issued for the Eagle Open-Circuit, Pressure-Demand, Entry and
Escape, Self-Contained Breathing Apparatus or Combination, Open-Circuit, Pressure-Demand,
Entry and Escape, Self-Contained Breathing Apparatus and Type C, Supplied-Air Respirator to
make the following changes as indicated on assembly matrix Eagle_AM26.XLS:
• To add four new airline/manifold pneumatic components, part numbers 1000001,
1000002, 1000003, and 1000004.
• To add a new supplement to the User Instructions part number A000009 for the air-line
attachments.
• To add hose/handwheel assemblies 1005 and 1006 to backframes 1007 and 1008 and
remove hose/handwheel assemblies 1000 and 1001.
Specifies the change(s)
This request is for the use of an alternate pneumatic accessory, change a handwheel assembly,
and update the User Instructions. No other components or processes are affected. All the
changes pass the testing required to meet the criteria for an SCBA and a Supplied-Air Respirator.
States how the change(s) affect(s) the product
The current designs do not allow the user the option of using different manifolds, and the
current handwheel is somewhat difficult to manipulate when wearing gloves. The new
arrangements allow the user to pick a manifold that suits their needs and the new handwheel is
easier to manipulate when wearing gloves.
Any time the approval holder makes a change to a critical or major characteristic, as defined in 42 CFR
Part 84, affecting performance and/or design (including Quality Assurance provisions), the change must
be submitted to NIOSH for approval. NIOSH will not assign new approval (TC) numbers for Extension of
Approval Applications. New approvals can only be granted under a New Approval Application.
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NIOSH will not assign new approval (TC) numbers for Extensions of Approval Applications. New
approvals can only be granted under a New Approval Application.
For SCBAs only, an Extension of Approval Application is acceptable for multiple changes affecting a single
SCBA even if it affects several major subassemblies.
For SCBAs with both Part 84 and CBRN approval, a Part 84 Extension of Approval Application cannot
contain changes to the CBRN approval. The only documents that may be submitted with this type of
application are those that are applicable to the Part 84 extension. When adding an accessory to an
already approved assembly, the applicant must include the accessory in the exploded-view drawing, the
assembly matrix, and the major subassembly drawings. If accessories are listed on the approval labels,
the labels must be updated.
Extensions of Approval Applications to add alternate components to respirators previously approved by
NIOSH apply to respirators that will be shipped from the manufacturer’s plant in the various
configurations. These Extensions of Approval Applications are not meant to apply to configuration
changes that will be done in the field either by the end user or by manufacturer representatives. If the
alternate components are to be field-replaceable, the approval holder must submit an Extension of
Approval Application for an upgrade (or retrofit) kit. The applicant must submit one application for each
upgrade (retrofit) kit that is being issued. The upgrade (retrofit) kit can be in the form of a parts list or a
drawing, and it must be listed on the assembly matrix with its own controlled document number and
revision level. If the upgrade (retrofit) kit is submitted as a picture drawing, the drawing must contain a
parts list. The manufacturer’s User Instructions to the field personnel or technician conducting the
upgrade (retrofit) must also be submitted as a controlled document and listed on the matrix. The first
time these items are listed on the matrix they will have a matrix code of “N.” Subsequent submittals will
be designated with a “R.”
When changes are made that affect the User Instructions, highlight or clearly note the changes in the
document.
1.2.3 Quality Assurance Approval Application
• Used for new or updated Quality Assurance (QA) Manuals only. This is for current NIOSH
approval holders only.
• No other actions will be accepted under this type of application.
• QA Manual changes must include a revision history sheet showing the revision date and reason
for revision.
Note: NIOSH will only accept QA Applications that request updates to the QA Manual. No other
requested actions will be accepted under a QA Application. QA Applications will not be accepted until
the requestor has at least one NIOSH-Approved product.
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In the “Reason for Application” state the details of the changes to the QA Manual. Also, indicate the
respirator(s) and manufacturing facility(ies) affected.
QA Approval Application submissions must not affect the performance or design of the respirator(s) and
must not result in a different type or level of protection. If the changes impact any of these aspects of
the covered respirator(s), then applicants must submit an Extension of Approval Application to address
these changes.
1.2.4 Resubmission of Applications
• Resubmissions are only accepted when allowed by NIOSH.
• Used for hardware or documentation previously denied by NIOSH.
If an application is for hardware or documentation that has been previously submitted to NIOSH and
denied, select request type ‘Resubmittal of New Application’ or ‘Resubmittal of Extension Application’ as
appropriate. The “Reason for Application” must include the changes made to address the respirator or
documentation deficiencies, an explanation of how the respirator or documentation now meets NIOSH
requirements, and the task number (TN) of the previously denied application. Failure to provide this
information will result in the application being denied again.
1.2.5 Amended Application
• Amended Applications are only accepted when requested by NIOSH.
• Used for open applications with an identified inaccuracy.
• Only the portion requested by NIOSH should be submitted.
• The AAR# and TN will remain the same.
1.2.6 Correlation Testing Only Application
Choose this type of application if the respirator is being submitted to be correlated with NIOSH Standard
Testing Procedures (STPs). NIOSH will only perform correlation testing using one of the NIOSH Standard
Test Procedures. The results of this testing cannot be used as pre-submission test data when submitting
the respirator for NIOSH approval. No approval will be issued with a Correlation Testing Only
Application.
Independent or internal testing is still required prior to submittal of the application. Explain what
testing is required, by STP number. NIOSH will only test the number of samples specified in the STP or
42 CFR Part 84. Specify the number of trials in the “Reason for Application” section.
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1.3 Approval Label Protections and Cautions and Limitations for
Self-Contained Breathing Apparatus and CBRN Self-Contained
Breathing Apparatus
PROTECTIONS
CBRN - Chemical, Biological, Radiological, and Nuclear
CF - Continuous Flow DE - Demand ESC - Escape
PD - Pressure-Demand SA - Supplied-Air SB - Supplied-Air Abrasive Blast
SC - Self-Contained
EOSTI-25 - End-of-Service-Time Indicator 25%
EOSTI-33 - End-of-Service-Time Indicator 33%
CAUTIONS and LIMITATIONS
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA,
OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the
configuration as specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance
of these respirators.
S Special or critical User Instructions and/or specific use limitations apply. Refer to User
Instructions before donning.
AA This respirator is to be used for escape only and will protect against the inhalation of certain
respiratory hazards.
CBRN-SPECIFIC CAUTIONS and LIMITATIONS
Q Use in conjunction with personal protective ensembles that provide appropriate levels of
protection against dermal hazard.
R Some CBRN agents may not present immediate effects from exposure, but can result in delayed
impairment, illness, or death.
T Direct contact with CBRN agents requires proper handling of the respirator after each use and
between multiple entries during the same use. Decontamination and disposal procedures must
be followed. If contaminated with liquid chemical warfare agents, dispose of the respirator after
decontamination.
U The respirator should not be used beyond 6 hours after initial exposure to chemical warfare
agents to avoid possibility of agent permeation.
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Section 2 Specific Instructions for Preparing a Self-Contained
Breathing Apparatus or CBRN Self-Contained Breathing
Apparatus Application Package
The paragraphs in this section are numbered to correspond to the different sections on
version 8 of the Standard Application Form (SAF).
1 Project Reference Numbers (Section C.1)
Enter the three character NIOSH-Assigned manufacturer’s code.
Check box if the applicant currently has a NIOSH-Approved product.
Assign a unique reference number to this application.
This reference number must start with the three character NIOSH-Assigned manufacturer’s code.
There is no character limit on this reference number.
This number must appear on each hardware sample package and the payment.
Never reuse the Applicant-Assigned Reference Number (AAR#) except on Amended Applications
requested by NIOSH.
NIOSH assigns a unique Task Number (TN) to each project.
This number is emailed to the applicant once the application is received along with accompanying
documents, check or payment confirmation, and test samples (hardware).
All inquiries must refer to either the NIOSH-Assigned TN or the AAR#.
2 Type of Application (Section C.2)
Select from: New Approval Application, Resubmission of New Approval Application, Extension of
Approval Application, Resubmission of Extension of Approval Application, Quality Assurance Application,
Correlation Testing Only Application, or Amended Application.
New Approval Application
• Used for new design, substantially modified design, or different type or level of
protection requested for an existing NIOSH-Approved respirator.
Resubmission of New Approval Application
• Resubmission will only be accepted when allowed by NIOSH.
• Used for previously denied applications.
Extension of Approval Application
• A change is made to any document that was evaluated by NIOSH as part of an approval.
• A critical or major characteristic affecting performance or design (including Quality
Assurance provisions) is altered on a previously approved respirator.
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• One new accessory is added to a previously approved respirator.
• A change is made to an approval label, assembly matrix, User Instructions, or drawings.
• A private label request is made.
• A product is made obsolete
Resubmission of Extension of Approval Application
• Resubmission applications are only accepted when allowed by NIOSH.
• Used for previously denied applications.
Quality Assurance Approval Application
• Choose this application for a new or updated QA Manual only.
• No other actions will be accepted under this type of application.
Correlation Testing Only Application
• Choose this type of application if the respirator is being submitted to be correlated with
NIOSH STPs.
• The results of this testing cannot be used as pre-submission test data when submitting
the respirator for NIOSH approval.
• Independent or internal testing is still required prior to submission of the application.
• Explain what testing is required and how many trials in the “Reason for Application.”
• No approval will be issued with a Correlation Testing Only Application.
Amended Application
• Amended submissions are only accepted when requested by NIOSH.
• Used for open applications with an inaccuracy in the application.
• Only the portion requested by NIOSH should be submitted.
• The AAR# and TN will remain the same.
3 and 5 Prospective Approval Holder (Section C.3 and Section C.5)
Enter the name of the prospective approval holder.
Status of Facility Manufacturer/Approval Holder Name (if different than above).
Check if the organization has submitted a request for approval for any respirator produced at this
manufacturing plant in the last three years.
Applicant – A person identified by the approval holder as completing and submitting the application.
Primary Contact – Person who will receive the approval or denial letter and all correspondence
concerning the application.
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Only those persons identified to NIOSH by the manufacturer/approval holder as official company
contacts should be listed on the application. Multiple contacts can be identified as required by the
manufacturer/approval holder.
Enter Official Title.
Enter the first and last name, middle initial, and suffix for the applicant.
Enter the name of the prospective approval holder, if different from above.
Enter the manufacturing plant address.
Enter the manufacturing plant phone number.
Click “add contact” to add information for another person who can answer questions related to this
application.
6 Date of Application (Section C.6)
Choose the date from the drop down calendar. The NIOSH date of application is when the application is
assigned a TN by NIOSH.
7 Type of Product (Section C.7)
Select Air-Supplying since this application applies only to Self-Contained Breathing Apparatus
Respirators.
8 Specific Questions Pertaining to Submission (Section C.8)
Is this a resubmittal of a previous application?
If Yes, enter the previous TN.
Is this an amended application?
Yes or No.
Is this submission application a result of field problem or site audit?
If Yes, enter the relevant TN(s).
Is the respirator intended for use in mines?
Yes or No.
This is for Part 84 applications only.
Is this application dependent upon the approval of an application in process?
If Yes, specify the applicable AAR# or TN.
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If the same respirator is being added as a private label, the second application cannot be approved until
the first application is approved.
If there are two or more applications that use the same assembly matrix, check the “yes” box and identify
all subsequent applications in the Approval History. The second and subsequent applications using the
same assembly matrix cannot be processed until the first application is approved. Additionally if a drawing
is currently under review at NIOSH and a separate matrix is submitted, the current application should indicate that
the project is dependent on the prior project and applicants should list the applicable TN.
9 Reason for Application (Section C.9)
Provide a complete, concise, descriptive reason for the application. Do not provide information relating
to respirator use or future respirator development. This is the information that will appear in the CEL.
The following must be addressed in the “Reason for Application”:
• If making respirators obsolete, include the TC numbers and model numbers.
List the TC numbers of all approvals affected by the application. If all of the TC numbers on the assembly
matrix apply to the extension, the assembly matrix may be referenced instead of the individual TC
numbers.
If an Extension of Approval Application is the result of a field problem, site audit, or product audit, state
that fact and list any associated task numbers (TN) here. Also, list the Corrective Action Request (CAR)
number associated with the application.
Please do not list “approval” as the “Reason for Application.”
Quality Assurance Approval Applications must state the details of the change(s) to the QA Manual and
the respirator(s) and manufacturing facility(ies) affected. QA Approval Applications must not affect
performance or design and must not result in a different type or level of protection.
Correlation Testing Only Applications must state which NIOSH Standard Testing Procedures is to be used
and indicate how many trials are requested. Special correlation tests that are not consistent with a
NIOSH Standard Testing Procedures will not be conducted unless previously agreed upon by NIOSH. An
approval will not be issued with a Correlation Testing Only Application.
Resubmittals must state the modification(s) that was (were) made to address the rejection/denial, and
demonstrate that the respirator or documentation now meets all requirements.
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10 Approval History (Section C.10)
Provide additional information on Approval History and any other information pertaining to this
application. Do not list additional requests in the Approval History.
If the application is one of a series being submitted, clearly list the AAR#s of all applications in the series.
Include a suggested processing order. Include an explanation how the applications build upon each
other. When using a common assembly matrix for the entire series of applications, place the assembly
matrix in the last application of the series and reference the application in which it is located in all
applications in the series. Applications in a series will not be approved until the entire series is
complete.
List the application TN where the respirator was last tested by NIOSH.
Example of a Well-Written Approval History for a Self-Contained Breathing Apparatus:
The new mask material is documented on revised specification sheet ZM-FL-A02 Rev A.
The change is documented in the mask's bill of materials (Item 2) on page 3 of drawing 103-01
Revision M.
This modification does not affect the respirator performance, but may affect facepiece fit. Happy
Breathing Company has tested the facepiece covering this extension and finds that it still meets
the requirements of 42 CFR Part 84 for facepiece fit. Happy Breathing Company has not changed
any of the respirator components since the components were granted NIOSH approval under TN-
xxxxx. The Happy Breathing Company is relying on the facepiece fit data accompanying this
submission, AAR#ph24, to obtain this approval.
This change will be applicable to the XXX mask and III respirator and private labels YYY & ZZZ.
11 Description of Respirator (Section C.11)
Information for New Approval Applications and Extension of Approval Applications is entered in the SAF
by selecting options from dropdown options. The respirator description fields vary based on the type of
respirator selected. Both New Approval Applications and Extension of Approval Applications require a
detailed narrative description.
Is this a joint SEI (CBRN NFPA) submission?
Yes or No.
Is this an SEI retrofit respirator?
Yes or No.
Is this a CBRN application?
Yes or No.
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Select type of CBRN, if applicable.
In this case, select SCBA if submitting for CBRN approval.
Is testing required?
Yes or No.
Return sample hardware?
Yes or No.
Note: If No, NIOSH will dispose of the equipment.
Source of submitted samples – Choose from dropdown options:
Prototype, Regular Production Unit, Correlation Test Sample.
If no testing is required, please provide the reason.
Facepiece type – Choose from the dropdown options:
Filtering Facepiece, Full Facepiece, Half-Mask, Quarter-Mask, Mouthpiece, Hood, Helmet, or
Tight-Fitting Full Facepiece with Neckdam Seal.
Fit – Choose from the dropdown options:
Tight-Fit, Loose-Fit, Both Tight- and Loose-Fit, or Mouthbit.
Is this respirator fit checkable?
Yes or No.
If the respirator contains electrical components, have the components been approved by MSHA for
intrinsic safety?
Yes, No, or Not Applicable.
Note: If the respirator is to be used in underground mines or for mine rescue and has electronics,
MSHA intrinsic safety approval must be received prior to submitting to NIOSH. However, if the
respirator is not intended for mine use or mine rescue, then the unit’s electrical components do not
require MSHA approval.
Does the respirator have an inhalation valve?
Yes or No.
Does the respirator have an exhalation valve?
Yes or No.
Move to Air-Supplied Respirator Questions
Type of Supplied-Air Respirator – Choose from dropdown options:
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Self-Contained Breathing Apparatus (SCBA), Supplied-Air Respirator (SAR), or Combination
SCBA/SAR.
SCBA Type – Choose from dropdown options:
Open-Circuit, Closed-Circuit, or Other Technology.
SCBA Use – Choose from dropdown options:
Escape-only or Entry and Escape.
SAR Category – Choose from dropdown options:
A, AE, A and AE, B, BE, B and BE, C, CE, C and CE, or Other.
Selected the Rated Service Time (minutes):
3, 5, 10, 15, 30, 45, 60, 120, 180, or 240.
Airflow – Choose from dropdown options:
Demand, Pressure-Demand, Continuous Flow, or Negative Pressure.
Breathing Gas – Choose from dropdown options:
Compressed Air, Compressed Oxygen, Compressed and Rich Air, Chemical Oxygen, Liquid
Oxygen, or Other Technology.
Enter the Concentration of Oxygen in Breathing Gas (percentage).
Enter the Cylinder Rating (psi).
Regulator Mounting Location – Choose from dropdown options:
Belt, Chest, Facepiece, Back or Backpack, or Helmet.
Are the materials used in the construction which may be exposed to oxygen at pressures above
atmospheric pressures, safe and compatible for their intended use?
Yes or No.
If a hose set is needed, click on “Add Hose Set” and provide the model number, hose type, shortest
length, maximum length, other lengths, total sections, valve type, and pressure.
Also provide a description of the respirator(s).
12 Intended Protection and Safety Design (Section C.12)
Atmosphere-Supplying respirators only:
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Confirm that any materials used in the construction of the respirator which may be exposed to oxygen
pressures above atmospheric pressure are safe and compatible for the intended use (e.g., exposure to
elevated concentrations of oxygen).
Identify CBRN when applicable.
The term “Intended for Mine Use” identifies respirators to be used for emergency use in mines. NIOSH
requires this information to determine if the application must be evaluated and approved by both
NIOSH and the Mine Safety and Health Administration (MSHA). Respirators to be used for mine rescue
and other emergency use in mines must be approved by MSHA under 30 CFR Part 75.1714. In addition,
if the respirator has electrical components, MSHA intrinsic safety approval must be received prior to
submitting to NIOSH. Any questions regarding the need for joint approval, please call NIOSH at 412-386-
4000.
13 Pre-Submission Performance Test Data and Statements (Section C.13)
Respirator pre-submission performance test data must accompany each application and must:
• Specify components used for test configuration by part number.
• Show units of measure for all test data (units of measure must match 42 CFR Part 84 Subparts
H through J criteria).
Submit copies of actual test data with all results and conclusions.
To verify which tests need to be performed as part of the pre-submission testing, please refer to the
Respirator Test Selection Guide. NIOSH expects that applicants will have performed each NIOSH test
and any additional tests the applicants deem appropriate during the process of validating that the device
meets NIOSH approval requirements.
Any respirators that have an EOSTI should list caution “S” on the approval label. Also, the User
Instructions must contain a special section that is labeled “S-Special or Critical User Instructions” where
the EOSTI information is contained. See Approval Labels in Section 7 for an example.
14 Model Numbers and Product Trade Names (Section C.14)
The information provided in this field is how the product will appear in the Certified Equipment List.
A product trade name that uniquely identifies the respirator or family is required. This name will be
listed in the Certified Equipment List for public reference. In version 8 of the electronic standard
application form for a New Approval Application, the model number field can be blank, but the product
trade name field must be completed before proceeding to the next data screen. A product trade name
may indicate a protection, but it may not imply use. Model numbers previously used for particulate
filtering devices approved under 30 CFR 11 standards may not be reused or carried over to devices or
configurations to be approved under 42 CFR Part 84 standards.
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15 Test Samples (Hardware) (Section C.15)
Regular production units submitted for approval must be the result of actual manufacturing processes
(42 CFR Section 84.11(e)).
Applications will be denied if the test samples (hardware) provided for testing did not go through the
manufacturer’s normal assembly, inspection, and test processes.
Applications may be denied even if the component that failed is not related to the “Reason for
Application.”
Use the Respirator Test Selection Guide to determine the minimum number of hardware samples
required for testing. Submit a sufficient number of hardware samples for testing at the time of
application. The hardware samples to be used for testing must be sent under a separate cover from the
application. In the application and on the packing slip with the hardware samples, list the item by part
number and description, and indicate the quantity submitted for testing. Include a copy of the User
Instructions in the box or shipping container with the hardware samples to be used for testing.
The outside of each box or shipping container and packing slip(s) should clearly indicate "Test
Samples/Hardware" along with the name of the applicant, AAR#(s), part number(s), and quantity(ies).
The hardware samples to be used for testing and any additional hardware samples requested by NIOSH
must clearly show the part number on each item, as it is listed on the assembly matrix, regardless of
how it is packaged. If additional hardware samples to be used for testing are requested by NIOSH, mark
the shipment to the attention of the NIOSH employee requesting the samples. Include the AAR#, TN,
and state “Additional Test Samples” on the outside of the box or shipping container. Cross-referenced
lists will not be accepted.
The applicant must submit prepaid return shipping labels or provide other return means with the
hardware samples for any materials to be returned upon completion of testing. “Please Return Samples”
should be indicated on the packing slip. If NIOSH denies an application based upon documentation
issues, the application, and in most cases, all hardware samples will be returned.
NIOSH does not retain hardware samples for any completed projects, approved or denied. The
hardware samples will be promptly destroyed unless the applicant indicates the samples should be
returned and prepaid return shipping instructions are provided. NIOSH is not responsible for customs
charges. The applicant is responsible for all shipping costs and making all arrangements to clear the
hardware samples through customs when shipping hardware samples to be used for testing to or from
NIOSH.
The test sample hardware submitted with the application will be tested. No substitutions, additions, or
deletions are permitted by the applicant once NIOSH receives the application.
If NIOSH evaluators determine a need for additional testing, additional test samples (hardware) may be
requested.
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Saving the Application
Once the application form has been completed, save the data file by selecting FILE, then SAVE AS, from
the menu bar on the main menu screen.
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Section 3 Supplemental Information for Preparing a Self-
Contained Breathing Apparatus or CBRN
Self-Contained Breathing Apparatus Application
3.
1 Quality Assurance Documentation
Understanding the requirements of 42 CFR Part 84 Subpart E and specific quality system characteristics
as noted below are necessary to adequately develop and maintain Quality Assurance and quality control
programs acceptable to NIOSH. Prior to obtaining any approvals under 42 CFR Part 84, all approval
holders are required to have an approved Quality Assurance Manual on file at NIOSH.
If an organization has an approved QA Manual and there is no change, complete the applicable blocks
on the SAF. If a previously approved QA Manual is being revised, it is not necessary to submit the entire
manual. In a separate QA application, submit only the sections that have been revised and an updated
revision history sheet.
3.2 Quality Assurance Manual
Submit a Quality Assurance Manual that documents the following elements at a minimum:
A. Statement of Quality Assurance.
- Upper management approval of the manual (usually a signature).
- A revision history sheet showing date and reason for revision.
- A Table of Contents.
- Management assurance that the QA system meets NIOSH requirements in 42 CFR Part
84 Subpart E.
B. Description of Management Responsibilities as they relate to:
- The company quality policy.
- Personnel/organization structure necessary to carry out these provisions.
- Verification of quality (internal auditing).
- Quality system review.
- International Standards Organization (ISO) certification (if applicable).
C. Structure of Quality System.
- Identify how quality procedures and instructions are prepared and implemented.
D. Contract Review Activities (as applicable).
E. Design Control for aspects of safety, performance, and dependability of the product reliability
programs.
F. Control of All Documents and Data (control of engineering drawings, documentations, and
changes).
G. Quality in Purchasing.
H. Control of Customer-Supplied Product (control of purchased material to include incoming
inspection).
I. Product Identification and Traceability.
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J. Control of Production Processes (lot identification, control of processes, manufacturing,
fabrication, and assembly work conducted in the plant).
K. All Areas of Inspection and Testing: Receiving, In Process, and Final Inspection.
L. Control of Inspection, Measuring, and Test Equipment.
M. Inspection and Test Status.
N. Control of Nonconforming Product.
O. Corrective and Preventive Actions (as applicable).
P. Inventory and Handling Controls.
Q. Control of Quality Records.
R. Internal Quality Audits (audit of final inspection of the completed product).
S. Training.
T. Servicing (as applicable).
Note: If the manual does not incorporate the specific elements within the document, then the manual
must link or list the Standard Operating Procedures (SOPs) for the various elements.
3.3 Product Quality Control Plan and Documentation
Product Quality Control Plan (PQP) documentation is required to be submitted as part of an application
to demonstrate to NIOSH the applicant’s process characteristics involved in controlling and monitoring
the quality of the respirator being manufactured.
Items that must be submitted are the:
A. PQP flowcharts showing all inspection and test operations. Identify each procedure by AAR#.
Inspection or test procedures clearly identified on the flow chart.
B. Sampling plan and classification of defects document as described in 42 CFR Section 84.41 (c),
(d), (e), (f), (g), and (h).
C. In process inspection and test procedures for items listed on the assembly matrix.
D. Final inspection and test procedures for the complete respirator and items listed on the assembly
matrix.
E. Simplified Self-Contained Breathing Apparatus respirator drawing.
F. Assembly matrix.
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3.4 Fees
An application fee of $200 is required at the time of submission for all approval requests. Checks are to
be made payable to NIOSH, dated less than 30 days prior to the submission date, and contain the AAR#.
The specific AAR# for the application must be written on the check. Checks older than 30 days may be
returned. Separate checks are required for each application submitted. Do not issue multiple
application fees on one check. Otherwise, checks will be returned and application processing delayed.
NIOSH will not begin processing the request until all items (application, check, and test samples
(hardware)) are received. If a domestic applicant utilizes Pay.Gov, send a copy of the Pay.Gov receipt to
the NIOSH NPPTL Records Room to facilitate linking the payment to the approval request.
As part of the Initial Review Process, an estimate of the costs anticipated to be incurred during the
evaluation will be provided. An email from the initial reviewer will be sent to the applicant towards the
end of the Initial Review Phase.
This estimate is prepared based on the “Reason for the Application,” the number of approvals affected,
and the assigned tests. In the event other testing or other additional cost items are identified after the
acceptance of the original estimate, the company will be contacted and an addendum to the estimate
will be forwarded for acceptance.
Once the applicant has provided authorization to the initial reviewer via email, the evaluation can begin.
During the Final Review Phase, an invoice for all fees, including testing of equipment, incurred in the
processing of an application will be generated. Invoices will contain specific payment instructions and
identify authorized methods of payment, and will be provided to the approval holder for payment.
Respirator Approval Application-Based fees are as follows:
Administrative Fees:
Fee Type
Legal Citation
Amount
Due Date
Application
42 CFR
§84.20(b)(1)
$200 per application submitted.
Upon receipt of any application
request. To be submitted with
application.
Approval
42 CFR
§84.20(b)(1)
$100 per each certificate of approval
issued.
Upon receipt of the invoice.
Approval
Modification
42 CFR
§84.20(b)(1)
$50 per each certificate of approval
modified.
Upon receipt of the invoice.
Site
Qualification
42 CFR
§84.20(b)(3)
• Existing approval holder, paper review:
$400 per each request to inspect new
p
roduction facility.
• Prospective approval holders:
▫ O
ne day domestic site visit - $2,500.
▫ One day international site visit - $7,500.
Upon agreement on the date of
the site qualification.
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Note: For any modification to an existing approval, such as changes to User Instructions or PQP, the
approval modification fee will be charged for all the approvals affected by this change. For example, if
the User Instructions are revised due to a change in a specific respirator, but the same User Instructions
are used on a family of respirators (example: family consists of 20 approvals), the approval modification
fee of $50 will be charged for all the approvals under that family of respirators (20 X $50 = $1,000).
Testing fees will be charged in accordance with the following fee tables and will be due upon receipt of
the invoice. The final letter (approval or denial) will be issued to the primary contact once all reviews
are complete. The invoice is to be paid within 30 days after receipt.
3.5 Combination Supplied-Air Respirators and Self-Contained Breathing
Apparatus, Self-Contained Breathing Apparatus, or CBRN Self-
Contained Breathing Apparatus Test Fees
All of these tests may not apply to the specific type of respirator being submitted.
These apply only to Supplied-Air and Self-Contained Breathing Apparatus Respirators.
Supplied-Air Testing Fees:
0100 Strength of Hose and Coupling, C and CE SAR
$150.00
0101 Tightness of Hose and Couplings, C and CE, SAR
$150.00
0102 Nonkinkability of Hose, C and CE, SAR $150.00
0103 Gasoline Permeability of Hose/Couplings, C and CE
$450.00
0104 Regulator 100,000 Cycle Test, Demand/PD, C/CE
$3,000.00
0105 Airflow Determination, CF, C and CE SAR
$300.00
0105A Airflow Determination, Demand/PD, C and CE SAR $300.00
0106 Inhalation Airflow Resistance, PD, C and CE SAR
$150.00
0107 Exhalation Airflow Resistance, PD, C and CE SAR
$150.00
0108 Inhalation Airflow Resistance, Demand, C/CE SAR
$150.00
0109 Exhalation Airflow Resistance, Demand, C/CE SAR $150.00
0110 Gas Tightness Test, IAA, C and CE SAR
$450.00
0111 Sound Level in Hood or Helmet, C and CE SAR
$450.00
0112 Protection Level, Abrasive Blast, CE, NaCl or Corn Oil
$450.00
0113 Airflow Resistance, CF, C and CE SAR $150.00
0118 Low Temperature Operation SCBA
$1,200.00
0119 Low Temp Operation, Combo SCBA and C/CE SAR
$1,200.00
0120 Positive Pressure, SCBA
$75.00
0121 Rated Service Time, SCBA, Demand and PD
$75.00
0121A Rated Service Time, CCSCBA, Demand and PD
$75.00
0122 Exhalation Resistance, SCBA, Demand and PD
$150.00
0123 Gas Flow Measurement, SCBA, Demand and PD
$150.00
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0124 Remaining Service Life Indicator, SCBA, Demand/PD
$150.00
0124A Alarm Pressure, CCSCBA, Demand and PD
$150.00
0125 Gas Tightness, IAA, SCBA, Facepiece and Mouthpiece $750.00
0125A Gas Tightness, IAA, SCBA, Hoods or Helmets
$750.00
0126 Bypass Valve Flow, SCBA, Demand and PD
$150.00
0128 Accuracy of Gauge, SCBA
$150.00
0133 Exhalation Breathing Resistance, PD SCBA $150.00
0139 CO
2
Facepiece Level Determination, SCBA
$450.00
0140 Man Tests, SCBA
$3,000.00
0145 Sound Level End of Service Life Indicator, SCBA
$750.00
0147 Mode Transfer Test, SCBA/SAR $150.00
0148 Remote Gauge Leak Flow, SCBA, Demand and PD
$150.00
New Site Qualification Fee, Existing Manufacturer
$400.00
Self-Contained Breathing Apparatus and Retrofit, CBRN:
0200 GB LAT
1
$9,142.00
0201 HD LAT
1
$9,142.00
0202 LRPL
$20,000.00
0202 Partial LRPL $16,000.00
0200/0201 Aerosol Process TDA-99M (SMARTMAN) Only
$600.00
Note:
1
Testing Performed at RDECOM.
Test Fees to be Charged for New and Unspecified Tests:
Emergency Breathing Safety System (EBSS)
testing for SCBA
$500/day for test, plus actual costs for test subjects
and required medical coverage.
$100/day per human test subject.
$1,300/day for medical staff.
A single payment (check or pay.gov) for multiple invoices is allowed. Include the AAR#s for each
associated application on the check or the pay.gov receipt so they will be properly credited. Separate
payments (check or pay.gov) will also be allowed for each application invoice. For application fee
invoices, included the TN number(s) associated with the payment. To indicate a final payment for a
specific application(s), add an -F after the TN number(s) (TN-nnnn-F).
3.6 Annual (Fixed) Certification (Approval) Fees
Annual (fixed) certification (approval) fees will be invoiced to approval holders who hold active or
obsolete certificates of approval. Invoices will be sent in September with payment due by October 30 of
the applicable year. Invoices will itemize the number of manufacturing sites and approvals and apply
the fees per the following table:
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Respirator Certification (Approval) Fee Schedule A—Annual (Fixed) Fees
Fee Type Legal Citation Amount Due Date
Maintenance of
Product
Performance
(Product Audit)
42 CFR
§84.20(b)(5)
• Annual fee: $761 per each approval holder.
• Variable fee: as billed by NIOSH based on the
respirators chosen to be tested each
year.
October 30 of applicable year.
Records
Maintenance
42 CFR
§84.20(b)(1)
$50 per every listed
1
approval on file with
NIOSH on July 1
st
of each year.
October 30 of applicable year.
Quality Assurance
Maintenance
(Site Audit)
42 CFR
§84.20(b)(4
)
• Annual fee: $3,000 per every manufacturing
site registered with NIOSH.
• Variable fee:
2
▫ 1
day domestic audit - $2,500 per site.
▫
2
day domestic audit - $5,000 per site.
▫ 1 day international audit - $7,500 per site.
▫ 2 day international audit - $10,000 per
site.
October 30 of applicable year.
Maintenance of
Testing and
Approval Facilities
42 CFR
§84.20(b)(2)
$34 per every listed
1
approval on file with
NIOSH on July 1
st
of each applicable year.
October 30 of applicable year.
Maintenance of
Test Equipment
42 CFR
§84.20(b)(2)
$36 per every active
3
approval on file with
NIOSH on July 1
st
of each applicable year.
October 30 of applicable year.
1. “Listed” approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects the current listed
approvals maintained by NIOSH.
2.
Applies to design as well as manufacturing sites.
3. Does not include obsolete approvals.
Checks are to be made payable to NIOSH, must be dated less than 30 days prior to the submittal date,
and must reference the AAR# or TN or NIOSH invoice number.
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3.7 Pay.Gov Instructions
Domestic applicants may use the electronic fees transfer program known as Pay.Gov.
Note: Prior to making any payment of respirator approval fees, applicants must establish an account
with Pay.Gov.
A. Follow the web link provided below:
a. PAY.GOV homepage: https://pay.gov/paygov/homepage.
B. On the center of the web page click on the link “Click here to register” to start the process or
go to the web page address provided below:
a. Registration: Pay.gov - Register for a Pay.gov Account.
b. Read the User Responsibility Statement, fill in the box, and select accept.
c. Select the “Continue with Self Enrollment” tab.
d. Complete the required fields in the Online Self Enrollment form and then select
“submit.”
e. Use Pay.Gov username and password to log into the Pay.Gov system from the
homepage.
f. Access the forms necessary to submit payments online using this process.
C. Fee Payment User Instructions.
a. Open the Pay.Gov homepage.
b. Locate the “User Fee Form.”
i. Go to the Find Public Forms section below the login.
ii. Search for forms by three options:
1. Form Name.
2. Agency Name.
3. Search Public Forms.
iii. Use one of three links listed on the six forms in the system for the Centers for
Disease Control and Prevention (CDC).
1. Form Name: CDC Royalty BMLA and User fee Form.
a. Select CDC User Fee Form.
2. Agency Name: CDC Royalty BMLA and User Fee Form.
a. Select CDC User Fee Form.
3. Search Forms: CDC Royalty BMLA and User Fee Form.
a. Select CDC User Fee Form.
4. Click on the form name to open the online fillable form.
iv. Complete the Online CDC User Fee Form.
1. Complete all mandatory blocks marked with asterisks.
2. Under CDC Invoice Number, enter the three digit Applicant-Assigned
Reference Number (AAR#).
a. If payment is for an existing Task Number (TN), enter the
associated TN.
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3. For “Payment Options,” select the “NIOSH User Fee” from the three
choices.
4. Enter a short description in the comments block regarding the
payment. Add any specific identifying information regarding the
submission that may help in processing the payment.
c. When submitting the form, users will be prompted to enter their Automated Clearing
House (ACH) debit information.
D. Currently Pay.Gov accepts payment directly by the Automated Clearing House (ACH) feature
or through credit or debit cards as follows:
a. Credit Cards: Visa, MasterCard, American Express, and Discover.
b. Debit Cards: Visa and MasterCard processed only.
Note: More in-depth instructions and information can be found at Pay.Gov homepage.
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3.8 Drawings for Self-Contained Breathing Apparatus or CBRN Self-
Contained Breathing Apparatus
All drawings must be in English. Drawings are accepted in Adobe PDF, ProEngineer, Autodesk, Smart
Draw, and Corel Draw. Drawings should be named using a unique identifier of the organization’s choice,
R for drawing, the revision level (e.g., a, b, c, etc.), and the file extension representing the software
program (e.g., nnnnRa.dwg). All engineering and CAD drawings must be saved and submitted in full
view mode. All engineering and CAD drawings must be submitted in black and white. The signature
blocks on each submitted drawing must contain the initials or signature of the preparer and approver
along with the approval date for the drawing revision.
3.
8.1 Exploded-View Drawing and Major Subassembly Drawing for a SCBA or
a CBRN SCBA
For Self-Contained Breathing Apparatus, the exploded-view drawing is the major subassembly drawing
and must include the complete respirator with critical or major dimensions, materials, and
characteristics as listed on the Self-Contained Breathing Apparatus drawing checklist. User Instructions
do not need to be illustrated on the exploded-view drawing. Do not include future submittals or
unapproved assemblies on the exploded-view drawing.
Use an identifying numbering system of the major subassemblies on the exploded-view drawing to
reference major subassemblies from the assembly matrix to the exploded-view drawing. The identifying
numbering system on the major subassemblies must match exactly with the assembly matrix.
If a facepiece is shown as item 1 on the assembly matrix, it must also be item 1 on the exploded-view
drawing. The applicant may use dotted lines around subassemblies on an exploded-view drawing to
group the smaller parts together into one major subassembly. If the profile of a component changes,
i.e., from a facepiece to a facepiece with a side window, the components must be shown separately as
1a, 1b, 1c, etc.
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3.8.2 Example of an Exploded-View Drawing for a SCBA or a CBRN SCBA
3.8.3 Major Subassembly Drawing for a SCBA or a CBRN SCBA
Applicants must submit major subassembly drawings for each major subassembly shown on the
exploded-view drawing. If a major subassembly is unchanged from a previous submittal and the
drawing is already on file at NIOSH, the drawing does not have to be resubmitted. The major
subassembly drawings may not contain future submissions or show unapproved assemblies.
All major subassembly drawings must meet the requirements defined in the “Major Subassembly
Drawing Checklists” found in Section 6. All drawings must be under the approval holder’s control and in
compliance with the document control system. Major subassembly drawing numbers and revision levels
must match exactly with those found on the assembly matrix.
DWM
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Major subassemblies must have permanent identifying part numbers marked on them. This part
number must appear in the part number row of the assembly matrix. The part number location must be
clearly shown on the major subassembly drawings.
3.8.4 Material Specifications on Drawings for a SCBA or a CBRN SCBA
For material specifications, use the criteria affecting performance or design.
For example, if an accessory would not affect the performance or design, materials could be identified
as plastic, metal, rubber, etc. However, if the items do affect performance or design, they would be
identified as aluminum, butyl rubber, etc. The phrase “or equivalent” should not be used.
3.9 Component Vendors
If the applicant controls all specifications for the component, the component vendors do not need to be
specified. If the applicant does not control all specifications of the component, then the applicant must
provide the name of the vendor. In accordance with 42 CFR Sections 84.42 (c) and 84.43 (c) the
approval holder is obligated to manufacture in accordance with the approved documentation. NIOSH
reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's
quality control test methods, equipment, or records do not ensure effective quality control over the
respirator for which the approval was issued. See the April 7, 2005 Letter to All Manufacturers on
“Clarification of Supplier and Subcontractor Relationships" for additional information.
3.10 Assembly Matrix
• An assembly matrix is a diagram of major subassemblies and accessories. It must be submitted
electronically in Microsoft Excel 97 (or later) format and it must be formatted as shown in the
example. The assembly matrix cannot be part of the exploded-view drawing.
• An “X” placed in the wrong box on a label or assembly matrix could delay the approval process.
Please verify the placement.
• Only one assembly matrix is necessary for a series of applications involving a common assembly
matrix. This assembly matrix must be submitted with the last application in the series.
• The AAR# for the application that contains the assembly matrix must be identified in the
Approval History section of each application in the series.
• When a new TC number is being requested, identify the rows for the new TC number using the
numbering convention of “schedule#, AAR#, alpha character” in the TC number column. For
example, for a Self-Contained Breathing Apparatus where the schedule# is 13F, followed by the
AAR# MOR699, and the TC number cell for the first row (a) of the new approval, the numbering
convention would be 13F-MOR699a. The second row would be numbered 13F-MOR699b, the
third row would be numbered 13F-MOR699c, etc.
• “TC-”can only appear in the column heading; do not use “TC-” in the assembly matrix row.
• Features that describe the respirator cannot be listed on the assembly matrix as a separate
column.
• Features associated with specific model numbers may be coupled together in the description
column heading (e.g., Model 1201-EZ Flow, Model 1202-EZ Flow, etc.).
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• The listing of User Instructions on Self-Contained Breathing Apparatus assembly matrices is
mandatory.
• More than one assembly matrix may be submitted with an application, if relevant.
• Columns with new information or revised information may be lightly shaded.
• Future submissions or unapproved assemblies should not be shown on the assembly matrices.
• Blank cells need to be entirely blank. The cells should not contain any unnecessary information,
spaces, embedded characters, hidden rows or columns, etc.
• The complete respirator or the respirator components listed on the assembly matrix must exactly
match those illustrated on the exploded-view drawing.
Some components may be an accessory on one approval and a required component on another. If a
component is an accessory, this must be explained in the “Reason for Application.” If this information is
not clearly stated, NIOSH will consider the component as required. The assembly matrix must list all
major subassemblies and accessories. The NIOSH evaluation status for each component or subassembly
must be indicated as follows:
X = An existing component or respirator that has been previously tested and
approved by NIOSH in this configuration.
N = A new component or respirator. If a new TC number has been requested, “N” must
appear in every column across the entire row. If an Extension of Approval is requested,
“N” should only appear in columns for respirators or components new to the approval.
P = Pending. A component or respirator submitted in an earlier application that is currently
being evaluated by NIOSH.
R = A redesign or revision to an existing component or respirator where the part number has
not changed. “R” is to be used indicating a change to any associated document with that
component.
- = A component or respirator designated by the approval holder as obsolete. Do not use
“double dash.” An obsolete item must be shown on the matrix as obsolete for the TC
number/part number combination at least once. Once organizations have submitted an
assembly matrix with obsolete items, they may drop these items from the matrix in
future submissions. If obsoleting an approval, dash marks must appear in every block
that a component for that approval was marked.
A = Accessory item. An item that does not affect the ability of a respirator to meet the
requirements of 42 CFR Part 84. The approval remains in effect whether the accessory is
used or not.
For easier review and evaluation, it is recommended that applicants lightly shade the rows and columns
containing new (N) or redesigned (R) components. If no cells are marked N or R, the applicant should
reconsider whether an application for approval is required. If in doubt, call NIOSH NPPTL Conformity
Verification and Standards Development Branch at (412) 386-4000.
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3.11 Approval Labels and Private Labels
Approval labels used in User Instructions, on packaging, or on devices must be legible. Labeling
requirements vary based on the type and intended use of the respirator. See example label formats for
Self-Contained Breathing Apparatus. The list of protections must be in the same order and identical to
the matrix. Submit draft versions of the appropriate labels.
Labels must be submitted for a New Approval, and for an Extension of Approval when the components
change. Labels must be created in Excel (97 or later) and follow the format of the examples.
Accessories may be listed on the approval label, but are not required. NIOSH will accept draft labels
with the location of the Health and Human Services (HHS) and NIOSH logos noted. Logos are available
on the NIOSH NPPTL homepage. The applicant is responsible for inserting the logos during label
production. Approval Labels may not contain future submittals or show unapproved assemblies.
3.12 List of NIOSH Cautions and Limitations for Self- Contained Breathing
Apparatus or CBRN Self-Contained Breathing Apparatus
SAR (Airline): A*, B, C, D, E, I*, J, K*, M, N, O, S*
SCBA: I*, J, M, N, O, S
CBRN SCER: I*, J, M, N, O, S*, R, X, AA, BB, DD, EE, JJ, GG, II, NN
CBRN SCBA: I*, J, M, N, O, S, Q, R, T, U
* Notes:
A For an SAR, this is not needed if the unit is equipped with an escape bottle.
I Applies if the respirator contains electrical components and the intrinsic safety has not
been evaluated and approved by MSHA or a recognized independent laboratory.
S With unique or unusual design or critical operation requirements or a
private label version.
AA Depending on use or design such as a mouthbit.
LL If protection varies depending on assembled configuration.
Closed-Circuit SCBA: An “S” will be assigned to all units referring users to the Special section
in the User Instructions. The User Instructions are to call out the following listed in Federal
Register Notice Volume 50. No. 222 published 11/18/85:
Limitations:
- Do not use this apparatus where there is direct exposure to flames or in high
radiant heat (this limitations applies to 100 percent oxygen apparatus only).
- Provide proper care, training and maintenance of the apparatus as specifically
described in the manufacturer’s instructions and maintenance manuals.
- After each use of this apparatus, a fully charged breathing gas container and a recharge of
carbon dioxide scrubber will be installed.
- Thorough cleaning and disinfecting of facepiece, breathing tube, and breathing
bag must be done in accordance with manufacturer’s instructions.
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Cautions:
- Keep exposed hair to a minimum when using apparatus near open flames or in radiant
heat.
- A good facepiece seal is important since facepiece leakage will seriously reduce service
time.
- Use of pure oxygen or oxygen enriched air increases flammability and lowers the ignition
temperature of most materials.
Cautions and limitations may vary or additional ones may apply depending on design and performance.
If the respirator contains electrical components and the applicant wishes to list the respirator on the
NIOSH approval label as intrinsically safe, obtain intrinsic safety approval from the MSHA under Title 30
CFR Part 18 or other recognized independent laboratory and submit verification of such approval in the
application. If the respirator is for underground use, MSHA intrinsic safety must be received prior to
submitting for NIOSH approval.
Combination units usually require all cautions and limitations from either type.
3.13 Private Labeling Versus Private Packaging
Private Labeling
Approval Holder A enters into an agreement to allow Company B to sell Approval Holder A’s respirator
as being manufactured by Company B. All packaging, labeling, markings, User Instructions, and
literature should indicate Company B. This approach appears to the user that the approval holder of the
respirator is Company B. The only reference to the actual approval holder is in a Special Instructions S
section. The respirator name, model number, and part number may or may not be the same as what is
used by Approval Holder A. The NIOSH TC number will not be changed. Approval Holder A remains
responsible for the respirator quality and all packaging, labeling, markings, and literature pertaining to
the NIOSH approval. Approval Holder A must ensure that the private labeler does not misrepresent the
NIOSH approval. Private labeling is always submitted to NIOSH by the approval holder for approval.
An Extension of Approval Application, submitted by the approval holder, is necessary for all private label
requests. If a part number or model number changes, the Extension of Approval Application must be
submitted showing this change in the assembly matrix and all labeling.
A Special Cautions and Limitation “S” is to be added to the private label approval label.
A specific section titled “S-Special Instructions Section” is to be added to the private label User
Instructions as follows:
The model/part number “respirator type” has been manufactured by Company (Approval Holder
A) for private label Company B under TC-XXY-nnnn.
Private Packaging
Approval Holder A enters into an agreement to have its respirators sold by Company B. Company B puts
the assembled respirator in a different or additional package. The respirator name, model number, part
number, respirator labeling, markings, User Instructions, and literature show Approval Holder A as the
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approval holder. The packaging may represent Company B and its catalog or other reference number.
However, this packaging must be done in a manner which does not mislead the user to think Company B
is the approval holder. Clarifiers, such as “Sold by Company B and Manufactured by Approval Holder A”
or “Made by Approval Holder A for Company B” must be included on the packaging. The NIOSH
approval label will not be changed. Approval Holder A remains responsible for respirator quality and all
packaging, labeling, markings, and literature that pertains to the NIOSH approval. Approval Holder A
must ensure that the private packager does not misrepresent the NIOSH approval. NIOSH does not need
to be notified of private packaging arrangements (no application needs to be submitted).
Note: Private packaging does not result in any changes to NIOSH documentation on file for the
approved respirator configuration. User Instructions and NIOSH approval labels provided on or with the
package must not be changed. Approval labels and the package artwork are part of the NIOSH
documentation and therefore must not be changed to remain a private packaging arrangement.
For both private labeling and private packaging arrangements, the approval holder is responsible for
notifying the private label or private package company of any changes in approval status, such as stop
sale, rescission, or revocation.
3.14 User Instructions
User Instructions must be submitted to NIOSH for Self-Contained Breathing Apparatus. User
Instructions must be listed on the assembly matrix for Self-Contained Breathing Apparatus, and are
required. An Extension of Approval Application is required for changes to the User Instructions. User
Instructions and associated procedures such as maintenance requirements, inspection procedures, and
donning and doffing instructions that pertain to the respirator submitted for approval must be
submitted as a complete package. When there is a change, NIOSH will not accept only the amended
pages. A complete User Instructions document must be submitted indicating what has been changed
either by highlighting the changed items or a cover page listing the page numbers and detailing
paragraphs updated. The file description for the User Instructions must clearly and specifically identify
the model or product line and revision level. Bold, underline, or otherwise indicate all changes to the
User Instructions from the prior revision level.
When an approval has a design or performance issue, corrections to the User Instructions is not
adequate to address the issue
For Caution and Limitation “S”, Special or Critical User Instructions, noted on the approval label and
listed in the User Instructions:
• Approval holders have discretion in what is identified as special cautions or limitations. To be
“special” the specific attribute of the respirator must go beyond the standard cautions and
limitations and be unique or unusual for the class of respirator.
• If the approval holder states “Special or Critical User Instructions or specific use limitations
apply,” the Special or Critical User Instructions must be readily identified within a separate
section of the User Instructions with the heading, “S - Special or Critical User Instructions.”
• Examples of special or critical instructions are special donning procedures, service life limitations,
and private labeled respirators.
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For private label respirators, the S-Special or Critical User Instructions section in the private label
holder’s User Instructions will state:
“The model/part number “respirator type” has been manufactured by Approval Holder A
(Company) for private label Company B under TC-13F-nnnn.”
If Special or Critical User Instructions or specific use limitations are stated, these items will be reviewed
to ensure the items are correct and appropriate.
For all tight-fitting respirators that must be fit tested prior to use, the following The Occupational Safety
and Health Administration (OSHA) reference must be included in the User Instructions under a Special
“S” titled listing:
Before occupational use of this respirator, a written respiratory protection program must be
implemented meeting all the local government requirements. In the United States, employers
must comply with OSHA 29 CFR 1910.134 which includes medical evaluation, training, and fit
testing.
Requirements Specific to Self-Contained Breathing Apparatus
The approval label may be located on the container or box or inserted in the package or in the User
Instructions.
The location of the approval label and User Instructions within the final packaging arrangement, are to
be stated either on the respirator drawing or as an attachment to these documents. Packaging artwork
is not required, but will be accepted as fulfillment of this requirement.
3.15 Packaging Art Work and Carton Design
In accordance with 42 CFR Section 84.33, the applicant will submit full scale reproductions of approval
labels and markings, and a sketch or description of the method of application and position on the
harness, container, canister, cartridge, filter, or other component, together with the instructions for use
and maintenance of the respirator.
Approval labels will include the HHS and NIOSH logos, the applicant's name and address, the approval
number assigned by NIOSH, and, where appropriate, restrictions or limitations on use of the respirator.
When additional labels, markings, or instructions are required, the applicant will be notified.
Approval labels and markings will only be used by the applicant to whom the labels were issued.
Legible reproductions or abbreviated forms of the label approved by NIOSH for use on each respirator
will be attached to or printed on the following locations:
Respirator type
Label type
Location
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Self-Contained Breathing
Apparatus
Entire
Harness assembly and canister (where applicable).
Supplied-Air Respirator
Entire
Respirator container or instruction card.
When a company receives and accepts a NIOSH approval, the company agrees to manufacture, inspect,
and test the respirator as it stated in the documentation as approved by NIOSH. The company will
maintain the PQP, as submitted and approved, and will not deviate from this plan. The plan will only be
changed after the company submits a request to NIOSH and this plan change is reviewed and approved
by NIOSH.
Each respirator, respirator component, and respirator container will, as required by NIOSH to assure
quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant,
and the name and letters or numbers by which the respirator or respirator component is designated for
trade purposes, and the lot number, serial number, or approximate date of manufacture.
Approval holders may not imply “use” for approved respirators.
Package advertising that is not permitted includes phrases such as:
“NIOSH-Approved Tactical SCBA”
Packaging may include a phrase such as: “NIOSH-Approved CBRN SCBA; recommended by the approval
holder for use in SWAT operations.”
3.16 Summary of Related Documents
Provide a complete and accurate listing of all new or revised files that pertain to the application. Give a
specific filename to each controlled document submitted with the application. The summary of related
documents must precisely match the electronic files submitted. Applications may be returned without
being processed if the summary is incorrect.
The following information must be included:
Filename:
XXX represents the three character NIOSH-Assigned manufacturer’s code and should only appear
on the application.
nnnn represents the unique characters chosen by the applicant.
The filename with extension must be listed, using Specific file naming conventions.
Spaces must not be used in filenames.
Filenames are derived from the controlled document number, not the AAR#.
For example, the filename for drawing 10222 revision A should be 10222Ra.dwg.
For future submissions of the same document, the only change to the filename will be to the
revision level; the next submission of the drawing above would be 10222Rb.dwg.
Files submitted using the AAR# as filenames will be returned.
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Document Type:
Pretest data, drawing, assembly matrix, draft approval label, QA Manual, PQP, service life plan,
User Instructions, etc.
Description:
Detailed description giving specific information identifying model name or number, revision level,
drawing number, and title.
Software program extension:
The software program (including version) used to create the file.
nnnn= unique identifying characters.
a, b, c, etc. = revisions.
.pdf, .xml, .xls, etc. = program used to create file.
In addition to the application file, the manufacturer must submit related project documents. These documents
must be in English and saved with the following file-naming conventions. Any files created in a language other
than English will be returned unprocessed.
3.17 File Naming Conventions
Required Documents
Naming Convention
Abbreviation
Acceptable Software
Packages
File Naming Convention Format
Application Form -
Microsoft Access
Java
Adobe Acrobat
XXXnnnn.MDB
XXXnnnn.xml
XXXnnnn.PDF
Pretest Data PD
Adobe Acrobat
Excel
Microsoft Word
nnnnPD.PDF
nnnnPD.XLS
nnnnPD.XLSX
nnnnPD.DOC
nnnnPD.DOCX
Drawings
R followed by revision
level (if applicable)
Adobe Acrobat
AutoCAD
Scanned file
nnnnRa.PDF
nnnnRb.DWG
nnnnRc.TIF
nnnnRd.GIF
nnnnRe.JPG
nnnnRf.BMP
(a-f indicate various revision levels)
Assembly Matrix
AM followed by revision
level (if applicable)
Excel
nnnnAMa.XLS
nnnnAMb.XLSX
Draft approval labels
DL followed by revision
level (if applicable)
Excel
nnnnnDLa.XLS
nnnnDLb.XLSX
Quality Assurance
(QA) Manual
QM followed by revision
level (if applicable)
Adobe Acrobat
Scanned file
Excel
M
icrosoft Word
nnnnQMa.PDF
nnnnQMb.TIF
nnnnQMc.XLS
nnnnQMd.XLSX
nnnnQMe.DOC
nnnnQMf.DOCX
Plus one signed paper copy
(a-f indicate various revision levels)
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Product Quality
Control Plan (PQP)
PQP followed by revision
level (if applicable)
Adobe Acrobat
Scanned file
AutoCAD
Excel
Microsoft Word
nnnnPQP.PDF
nnnnPQP.TIF
nnnnPQP.DWG
nnnnPQP.XLS
nnnnPQP.XLSX
nnnnPQP.DOC
nnnnPQP.DOCX
Fees
-
Paper or PAY.GOV only
Paper or PAY.GOV only
Service Life Plan
(If Required)
SLP followed by revision
level (if applicable)
Adobe Acrobat
Scanned file
E
xcel
Microsoft Word
nnnnSLP.PDF
nnnnSLP.TIF
nnnnSLP.JPG
nnnnSLP.BMP
nnnnSLP.PNG
nnnnSLP.XLS
nnnnSLP.XLSX
nnnnSLP.DOC
nnnnSLP.DOCX
User Instructions
UI followed by revision
level (if applicable)
Adobe Acrobat
Scanned file
Microsoft Word
nnnnUIa.PDF
nnnnUIb.TIF
nnnnUIc.DOC
nnnnUId.DOCX
(a-d indicate various revision levels)
• If “zipped” files are submitted, provide the individual filename, description, and program for each
working file contained in the zipped file.
• If there is more than one User Instructions or assembly matrix, list each in the assembly matrix
by name.
• If NIOSH has requested replacement files, give the replacement files the same name as the
original files.
• Send replacement files only at the request of NIOSH, and send the replacement files directly to
the NIOSH employee requesting the files. The requestor is responsible for having the corrected
files posted to the project.
• NIOSH will only accept replacement or new files that were requested by NIOSH.
• NIOSH will only accept single documents under a single filename. Multiple documents under a
single filename will not be accepted and the application may be denied.
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Section 4 Approvals and Denials
4.1 Approval Documentation
If the respirator complies with all of the requirements outlined in these procedures and 42 CFR Part 84,
NIOSH will grant an approval and assign a TC number.
All submitted documentation and supporting test data will become part of the approval record. NIOSH
will send a letter to the applicant’s primary contact stating the nature of the approval and will return
final approval label files, if applicable, with the appropriate approval documentation. Applicants may
use consultants or authorized representatives as contacts for the application. These contacts may
submit applications either by request of the company primary contact or in place of the company
primary contact. Foreign companies may provide a U.S. contact as a consultant or authorized
representative. For applicants using consultants or authorized representatives, the final letter of
approval and enclosed documentation will be sent directly to the applicant with a copy of the approval
letter to the consultant or authorized representative. All approval documentation and application
discussions will still be done through the company primary contact.
When application approval labels and assembly matrices contain rows of information for approvals
other than the ones evaluated in the individual application under review, approval letters will indicate
that only the approvals indicated (or marked requested) under the individual application are granted.
4.2 Denial Documentation
If the respirator fails to meet the requirements of 42 CFR Part 84, the application will be denied and all
documentation, CD-Rs or DVD-Rs, and test samples (hardware) will be returned or destroyed. NIOSH
will not retain documentation or test samples (hardware) for any respirator that has failed to meet all of
the requirements. If NIOSH denies an application based upon documentation issues, the application,
CD-Rs or DVD-Rs, and all sample hardware will be returned to the applicant’s U.S. or Canadian address
or authorized representative. It is recommended that foreign applicants have and use their U.S.
representative’s address on return shipping labels.
Note: If any failure occurs in a series of applications, all related applications will also be denied.
Subsequent requests for approval of previously failed units must be submitted with all associated
documentation and the reason for failure must be addressed.
4.3 Denial Prior to Assignment of a Task Number
Some of the reasons applications will not be accepted and will be denied prior to issuance of a TN
include:
• An application is assigned a previously used AAR#.
• A major section of the application such as the assembly matrix, QA Manual, approval labels,
pretest data, User Instructions, or drawing package is missing, is in an unacceptable file format,
or uses an unacceptable file naming convention.
• Test samples (hardware), application package, and payment are not received within two weeks
of one another.
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• Shipping boxes contain sample test (hardware) associated with different applications and
without separate packaging to indicate what sample hardware goes with each application.
• Packages of sample test (hardware) received within the same box are not clearly labeled.
• An assembly matrix is not associated with every application (except QA Applications).
• A complete file list is not included in the related documents section of the application.
4.4 Denial of a Project Undergoing NIOSH Evaluation
Some of the reasons why applications may be denied after issuance of a TN include:
• Assembly matrix, exploded-view drawing, approval labels, or major subassembly drawings are
incorrect (content or format) or show unapproved assemblies.
• Pre-submission test data is not complete. For example, it does not include total resistance on
the complete assembly or all assemblies involved in the submittal(s).
• Sample hardware submitted does not match subassembly drawings, part numbers, or the
assembly matrix drawing.
• Drawings are not in accordance with the documentation control procedures stated in the
applicant’s Quality Assurance Manual.
• Additional information requested by NIOSH is not received within two weeks of the date
requested.
• The application is for a new or unique respirator which cannot be approved under current
regulations for which there is no existing NIOSH policy (e.g., smoke hoods, SAR with pneumatic
tools, etc.).
• Applicant’s pre-submission test data indicates that the respirator would fail the NIOSH regulatory
test requirements or the appropriate pretest data is not submitted with the application.
• The official submittal either (1) requested approval of two respirators of different basic designs
(includes submitting a SCBA unit for entry and escape and an alternate unit for escape-only in the
same application) or (2) requested a new approval and an extension of approval action in the
same application.
• The Standard Application Form (SAF) has errors, deficiencies, or is incorrect.
• Items on the assembly matrix do not correspond exactly to the “Reason for Application,” drawing
revision levels are wrong, components on the exploded-view drawing are improperly numbered,
or documents are otherwise incorrect.
• Protection or intended use claims have not been requested or approval has not been obtained
from other governing agencies (such as MSHA for mine use with MSHA intrinsic safety or intrinsic
safety from recognized laboratories).
• QA documentation does not have sufficient inspections identified, is missing required inspection
steps, or inspections identified are not sufficient to meet the NIOSH requirements.
• The Quality Assurance Application includes other documents, such as a PQP or inspection
procedures, in addition to or instead of the Quality Assurance Manual.
4.5 Respirator Certification (Approval) Program Decision Review Process
NIOSH NPPTL has a structured Decision Review Process that enables applicants to request a review of
decisions regarding NIOSH NPPTL policy statements, test procedures, and test results pertaining to
ongoing respirator approval activities.
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Section 5 Test Selection Guide for Self-Contained Breathing
Apparatus and CBRN Self-Contained
Breathing Apparatus
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
7
SCBA - open-circuit,
entry, demand
Subpart H
TEB-APR-STP-0004
Determination of Exhalation
Valve Leakage
2 complete units plus one each of
all accessories
3 cylinder gauges,
3 remote gauges, as required
RCT-ASR-STP-0118
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Open-Circuit, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0121
Determination of Rated
Service Time - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0122
Determination of Exhalation
Breathing Resistance - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0123
Determination of Gas Flow
Measurements - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0124
Determination of Remaining
Service-Life Indicator - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0125
Determination of Gas
Tightness - Isoamyl Acetate,
(IAA) - Self-Contained
Breathing Apparatus with
Facepieces and Mouthpieces
RCT-ASR-STP-0126
Determination of Bypass
Valve Flow - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0132
Determination of Inhalation
Breathing Resistance - Open-
Circuit, Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
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RCT-ASR-STP-0145
Determination of Sound Level
Measurements for Remaining
Service Life Indicators - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0146
Determination of Diaphragm
Over Pressurization - Open
Circuit, Self-Contained
Breathing Apparatus with Belt
Mounted Regulators and
Breathing Tubes
RCT-ASR-STP-0148
Determination of Remote
Gauge Leak-Flow Test - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0155
Man Test Number 6 - Self-
Contained Breathing
Apparatus Using Liquefied
Gas
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
8
SCBA - open-circuit,
entry, pressure-
demand
RCT-ASR-STP-0118
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Open-Circuit, Self-
Contained Breathing
Apparatus
2 complete units plus one each of
all accessories
3 cylinder gauges
3 remote gauges, as required
RCT-ASR-STP-0120
Determination of Positive
Pressure - Open-Circuit,
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0121
Determination of Rated
Service Time - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0122
Determination of Exhalation
Breathing Resistance - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0123
Determination of Gas Flow
Measurements - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0124
Determination of Remaining
Service Life Indicator - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0125
Determination of Gas
Tightness - Isoamyl Acetate,
(IAA) - Self-Contained
Breathing Apparatus with
Facepieces and Mouthpieces
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RCT-ASR-STP-0126
Determination of Bypass
Valve Flow - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0145
Determination of Sound Level
Measurements for Remaining
Service-Life Indicators - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0146
Determination of Diaphragm
Over Pressurization - Open
Circuit, Self-Contained
Breathing Apparatus with Belt
Mounted Regulators and
Breathing Tubes
RCT-ASR-STP-0148
Determination of Remote
Gauge Leak-Flow Test - Open-
Circuit, Demand And
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0155
Man Test Number 6 - Self-
Contained Breathing
Apparatus Using Liquefied
Gas
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
9
SCBA - closed-circuit,
entry
RCT-ASR-STP-0117
Determination of Positive
Pressure - Closed-Circuit,
Pressure-Demand, Self-
Contained Breathing
Apparatus
2 complete units, plus one each of
all accessories
21 scrubbers or 0
2
generating canisters
or
21 fully charged 0
2
cylinders
plus
1 breathing bag
1 relief valve override tool (if
needed)
3 cylinder gauges
3 remote gauges (if needed)
RCT-ASR-STP-0121A
Determination of Rated
Service Time - Closed-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0124A
Determination of Alarm
Pressure - Closed-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0125
Determination of Gas
Tightness - Isoamyl Acetate,
(IAA) - Self-Contained
Breathing Apparatus with
Facepieces and Mouthpieces
RCT-ASR-STP-0127
Determination of Bypass
Valve Flow - Closed-Circuit,
Demand, Self-Contained
Breathing Apparatus
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RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0134
Determination of Gasoline
Permeation Test on Breathing
Bags - Closed-Circuit, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0135
Determination of Inhalation
and Exhalation Breathing
Resistance - Closed-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0136
Determination of Demand
Gas Flow - Closed-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0137
Determination of Continuous
Gas Flow on Constant Flow
with Demand Flow - Closed-
Circuit, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0138
Determination of Safety Relief
Valve Operation - Closed-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0141
Man Test Number 5 - Closed-
Circuit, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0142
Determination of Vibration
(Ro-Tap Test) For Man Test
Number 1 - Escape, Closed-
Circuit, Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0143
Determination of Low-
Temperature Operation -
Minimum per Manufacturer -
Closed-Circuit, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0144
Determination of Continuous
Gas Flow on Constant Flow -
Closed-Circuit, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0145
Determination of Sound Level
Measurements for Remaining
Service Life Indicators - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0146
Determination of Diaphragm
Over-Pressurization - Open
Circuit, Self-Contained
Breathing Apparatus with Belt
Mounted Regulators and
Breathing Tubes
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RCT-ASR-STP-0148A
Determination of Remote
Gauge Leak-Flow Test -
Closed-Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0155
Man Test Number 6 - Self-
Contained Breathing
Apparatus Using Liquefied
Gas
NOTE: Rated service time is tested during Man test 4,
assuming that all previous Man tests have been
satisfactorily completed.
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
11
SCBA - open-circuit
escape, demand
RCT-ASR-STP-0118
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Open-Circuit, Self-
Contained Breathing
Apparatus
2 complete units plus one each of
all accessories
3 cylinder gauges
RCT-ASR-STP-0121
Determination of Rated
Service Time - Open-Circuit,
Demand and Pressure-
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0122
Determination of Exhalation
Breathing Resistance - Open-
Circuit, Demand and
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0123
Determination of Gas Flow
Measurements - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0125
Determination of Gas
Tightness - Isoamyl Acetate,
(IAA) - Self-Contained
Breathing Apparatus with
Facepieces and Mouthpieces
RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0132
Determination of Inhalation
Breathing Resistance - Open-
Circuit, Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
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12
SCBA - open-circuit
escape, pressure-
demand
RCT-ASR-STP-0118
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Open-Circuit, Self-
Contained Breathing
Apparatus
2 complete units plus one each of
all accessories
3 cylinder gauges
RCT-ASR-STP-0120
Determination of Positive
Pressure - Open-Circuit,
Pressure-Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0121
Determination of Rated
Service Time - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0123
Determination of Gas Flow
Measurements - Open-Circuit,
Demand, Self-Contained
Breathing Apparatus
RCT-ASR-STP-0125
Determination of Gas
Tightness - Isoamyl Acetate, -
Self-Contained Breathing
Apparatus with Facepieces
and Mouthpieces
RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
13
SCBA - open-circuit
escape, constant
flow
RCT-ASR-STP-0114
Determination of Sound Level
Measurement - Escape, Open-
Circuit, Self-Contained
Breathing Apparatus Using
Hoods or Helmets
3 complete units
RCT-ASR-STP-0115
Determination of Rated
Service Time – Constant Flow,
Escape, Open-Circuit, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0116
Determination of Airflow
Resistance - Continuous-Flow,
Escape, Open-Circuit, Self-
Contained Breathing
Apparatus With Hoods
RCT-ASR-STP-0118
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Open-Circuit, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0125A
Determination of Gas
Tightness - Isoamyl Acetate, -
Self-Contained Breathing
Apparatus with Hoods or
Helmets
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RCT-ASR-STP-0128
Determination of Accuracy of
Gauge - Self-Contained
Breathing Apparatus
RCT-ASR-STP-0132
Determination of Inhalation
Breathing Resistance - Open-
Circuit, Demand, Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0139
Determination of Facepiece
Carbon Dioxide
Concentrations - Self-
Contained Breathing
Apparatus
RCT-ASR-STP-0140
Man Tests - Self-Contained
Breathing Apparatus
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
14
SA Type C-CE,
demand
Subpart J
TEB-APR-STP-0004
Determination of Exhalation
Valve Leakage
2 complete units plus one each of
all accessories
All combinations of the maximum
length of hose made up from the
plus
All necessary Quick Disconnects
2 additional 25-foot lengths of air-
line hose
RCT-ASR-STP-0100
Determination of Strength of
Hoses and Couplings - Type C
and CE Supplied-Air
Respirators
RCT-ASR-STP-0101
Determination of Tightness of
Hoses and Couplings - Type C
and CE, Supplied-Air
Respirators
RCT-ASR-STP-0102
Determination of
Nonkinkability of Hoses - Type
C and CE, Supplied-Air
Respirators
RCT-ASR-STP-0103
Determination of Gasoline
Permeation of Hoses and
Couplings - Type C, and CE,
Supplied-Air Respirators
RCT-ASR-STP-0104
Determination of Air-
Regulating Valve 100,000
Cycles Performance - Demand
and Pressure-Demand, Type C
and CE, Supplied-Air
Respirators
RCT-ASR-STP-0105A
Determination of Airflow -
Demand, Type C and CE,
Supplied-Air Respirators
RCT-ASR-STP-0108
Determination of Inhalation
Airflow Resistance - Demand,
Type C and CE, Supplied-Air
Respirators
RCT-ASR-STP-0109
Determination of Exhalation
Airflow Resistance - Demand,
Type C and CE, Supplied-Air
Respirators
RCT-ASR-STP-0110
Determination of Gas-
Tightness Test - Isoamyl
Acetate, - Type C, and CE,
Supplied-Air Respirators
NOTE: For abrasive blast, type CE, supplied-air
respirators, perform all above tests plus
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RCT-ASR-STP-0112
Determination of the Level of
Protection Provided by
Abrasive Blast, Type CE,
Supplied-Air Respirators Using
a Challenge Aerosol of NaCl
(Sodium Chloride) or Corn Oil
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
15
SA Type C-CE,
pressure-demand
TEB-APR-STP-0004
Determination of Exhalation
Valve Leakage
2 complete units plus one each of
all accessories
All combinations of the maximum
length of hose made up from the
plus
All necessary Quick-Disconnects
2 additional 25-foot lengths of air-
line hose
RCT-ASR-STP-0100
Determination of Strength of
Hoses and Couplings - Type C
and CE Supplied-Air
Respirators
RCT-ASR-STP-0101
Determination of Tightness of
Hoses and Couplings - Type C
and CE, Supplied-Air
Respirators
RCT-ASR-STP-0102
Determination of
Nonkinkability of Hoses - Type
C and CE, Supplied-Air
Respirators
RCT-ASR-STP-0103
Determination of Gasoline
Permeation of Hoses and
Couplings - Type C, and CE,
Supplied-Air Respirators
RCT-ASR-STP-0104
Determination of Air-
Regulating Valve 100,000
Cycles Performance - Demand
and Pressure-Demand, Type C
and CE, Supplied-Air
Respirators
RCT-ASR-STP-0105A
Determination of Airflow -
Demand, Type C and CE,
Supplied-Air Respirators
RCT-ASR-STP-0106
Determination of Inhalation
Airflow Resistance - Pressure-
Demand, Type C and CE,
Supplied-Air Respirators
RCT-ASR-STP-0107
Determination of Exhalation
Airflow Resistance - Pressure-
Demand, Type C and CE,
Supplied-Air Respirators
RCT-ASR-STP-0110
Determination of Gas-
Tightness Test - Isoamyl
Acetate, - Type C, and CE,
Supplied-Air Respirators
NOTE: For abrasive blast, type CE, supplied-air
respirators, perform all above tests
plus
RCT-ASR-STP-0112
Determination of the Level of
Protection Provided by
Abrasive Blast, Type CE,
Supplied-Air Respirators Using
a Challenge Aerosol of NaCl
(Sodium Chloride) or Corn Oil
* Actual tests selected may vary depending on design
and intended use.
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Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
16
SA Type C-CE,
constant flow
TEB-APR-STP-0004
Determination of Exhalation
Valve Leakage
2 complete units plus one each of
all accessories
All combinations of the maximum
length of hose made up from the
plus
All necessary Quick Disconnects
2 additional 25-foot lengths of air-
line hose
RCT-ASR-STP-0100
Determination of Strength of
Hoses and Couplings - Type C
and CE Supplied-Air
Respirators
RCT-ASR-STP-0101
Determination of Tightness of
Hoses and Couplings - Type C
and CE, Supplied-Air
Respirators
RCT-ASR-STP-0102
Determination of
Nonkinkability of Hoses - Type
C and CE, Supplied-Air
Respirators
RCT-ASR-STP-0103
Determination of Gasoline
Permeation of Hoses and
Couplings - Type C, and CE,
Supplied-Air Respirators
RCT-ASR-STP-0105
Determination of Airflow -
Continuous Flow, Type C and
CE, Supplied-Air Respirators
RCT-ASR-STP-0110
Determination of Gas-
Tightness Test - Isoamyl
Acetate, - Type C, and CE,
Supplied-Air Respirators
RCT-ASR-STP-0111
Determination of Air Velocity
and Noise Levels - Sound
Level, Type C and CE,
Supplied-Air Respirators
RCT-ASR-STP-0113
Determination of Airflow
Resistance - Continuous-Flow,
Type C and CE, Supplied-Air
Respirators
NOTE: For abrasive blast, type CE, supplied-air
respirators, perform all above tests
plus
RCT-ASR-STP-0112
Determination of the Level of
Protection Provided by
Abrasive Blast, Type CE,
Supplied-Air Respirators Using
a Challenge Aerosol of NaCl
(Sodium Chloride) or Corn Oil
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
18
Combinations of any
respirators in this
guide
All tests for each category as appropriate
plus
All samples for each category as
appropriate
For combination SCBA/SAR:
RCT-ASR-STP-0119
Determination of Low
Temperature Operation -
Minimum Temperature per
Applicant, Combination,
Open-Circuit, Self-Contained
Breathing Apparatus and Type
C, and CE, Supplied-Air
Respirators
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RCT-ASR-STP-0147
Determination of Mode
Transfer Test - Combination,
Open-Circuit, Self-Contained
Breathing Apparatus and
Supplied-Air Respirators
(SCBA/SAR)
For Combination SAR/AP:
RCT-APR-STP-0014
Determination of Leakage Of
Drinking Tube and
Accessories for Respirator
Facepieces
* Actual tests selected may vary depending on design
and intended use.
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
23
CBRN SCBA, Open-
Circuit (CBRN SCBA)
(Must be in
conjunction with Part
84 testing and
NFPA/SEI 1981
submittal)
RCT-CBRN-STP-0200,
0201
Determination of Open-
Circuit, Self-Contained
Breathing Apparatus (SCBA)
Performance During Dynamic
Testing Against Chemical
Agents of Sarin (GB) Vapor
and Distilled Sulfur Mustard
(HD) Vapor and Liquid
GB LAT +
HD LAT +
2 SCBA units, low pressure without
cylinder, live agent testing
4 SCBA units, high pressure,
without cylinder, live agent testing
2 spare SCBA unit for live agent
testing without cylinder
48 Facepieces with P100 filters
configured in the air-purifying
mode for LRPL
2 SCBA units per pressure for
Emergency Breathing Safety
Systems (EBSS) testing
202
Contact NIOSH NPPTL for STP
Draft test procedure in place, but
final STP has not been published.
Contact NIOSH NPPTL for more
information at 412-386-4000.
TEB-CBRN-ASR-STP-
0219
Determination of Open-
Circuit, Self-Contained
Breathing Apparatus,
Emergency Breathing Safety
Systems (EBSS) Functionality
During Low Temperature
Operation
TEB-CBRN-ASR-STP-
0220
Determination of Positive
Pressure - Open-Circuit,
Pressure-Demand, Self-
Contained Breathing
Apparatus During Emergency
Breathing Safety System,
Full-Flow Operation
+Tests performed at RDECOM
* Actual tests selected may vary depending on design
and intended use
Item
Respirator
Type
*NIOSH Test #
Title
Total Materials Needed
24
CBRN SCERs
TEB-APR-STP-0003
Determination of Exhalation
Resistance
4 complete respirators without
cylinders for live agent testing
qualification
6 complete respirators without
cylinders for live agent testing
after environmental conditioning
115 complete respirators for
bench testing minimum
TEB-APR-STP-0004
Determination of Exhalation
Valve Leakage
TEB-APR-STP-0007
Determination of Inhalation
Resistance
RCT-APR-STP-0064
Determination of Facepiece
Carbon-Dioxide and Oxygen
Concentration Levels - Tight-
Fitting, Powered Air-Purifying
Respirators, With the Blower
Unit Off
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CET-APRS-STP-CBRN-
0312
Determination of Field of
View for Full Facepiece
Chemical, Biological,
Radiological, and Nuclear
Respiratory Protective
Devices
CET-APRS-STP-CBRN-
0411
Laboratory Durability
Conditioning Process for
Environmental,
Transportation and Rough
Handling Use Conditions on
Chemical, Biological,
Radiological and Nuclear Air-
Purifying or Self-Contained)
Escape Respirator
CET-APRS-STP-CBRN-
0414
Fogging
Draft test procedure for fogging is
in place, but final STP has not been
published. Contact NIOSH for
further information.
TEB-APR-STP-0417-
CBRN
Determination of
Flammability and Heat
Resistance, CBRN Air-
Purifying Escape Respirators
CET-APRS-STP-CBRN-
0450
Determination of Chemical
Agent Permeation and
Penetration Resistance
Performance Against Sarin
Vapor of Chemical, Biological,
Radiological, and Nuclear Air-
Purifying Escape Respirator
GB (SMARTMAN) Qualifier
LAT(QLAT) Only 1 +
CET-APRS-STP-CBRN-
0450
Determination of Chemical
Agent Permeation and
Penetration Resistance
Performance Against Sarin
Vapor of Chemical, Biological,
Radiological, and Nuclear Air-
Purifying Escape Respirator
GB (SMARTMAN) Remainder
LAT (RLAT) 2 trials +
CET-APRS-STP-CBRN-
0451
Determination of Chemical
Agent Permeation and
Penetration Resistance
Performance Against Sulfur
Mustard Liquid And Vapor of
the Chemical, Biological,
Radiological, and Nuclear Air-
Purifying Escape Respirator
HD (SMARTMAN) QLAT Only 1
+
CET-APRS-STP-CBRN-
0451
Determination of Chemical
Agent Permeation and
Penetration Resistance
Performance Against Sulfur
Mustard Liquid And Vapor of
the Chemical, Biological,
Radiological, And Nuclear Air-
Purifying Escape Respirator
HD (SMARTMAN) RLAT 2 trials
+
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TEB-CBRN-APR-STP-
0452
Determination of Laboratory
Respirator Protection Level
Values for CBRN Air-Purifying
Escape Respirator
CET-APRS-STP-CBRN-
0455
Human Subject Breathing Gas
Test
Draft test procedure for human
subject breathing gas test is in
place, but final STP has not been
published. Contact NIOSH for
further information.
+Tests performed at RDECOM.
* Actual tests selected may vary depending on design
and intended use.
All of the NIOSH Standard Test Procedures are located at:
https://www.cdc.gov/niosh/npptl/stps/respirator_testing.html.
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Section 6 Checklists for Self-Contained Breathing Apparatus
or CBRN Self-Contained Breathing Apparatus
The following checklists will be used by NIOSH to review submitted documents for compliance to this
procedure and 42 CFR Part 84. It is recommended that applicants review their documents using these
checklists prior to submitting them to NIOSH. These checklists may not be all-inclusive.
6.1 NIOSH Respirator Application Checklist
1. _____ The AAR# is unique to the application.
2. _____ All the applicable sections of the SAF are complete.
3. _____ The “Reason for Application” accurately reflects why the application is being submitted
(e.g. New Approval, Extension of Approval, Quality Assurance Approval, Correlation
Testing Only, Resubmission of New Approval, Resubmission of Extension of Approval,
or Amended Application).
4. _____ The NIOSH TN under which this (these) respirator(s) were last tested has been
identified.
5. _____ All the files included with the application are listed in the SAF.
6. _____ All the files supplied are in the acceptable file formats.
7. _____ All the files are properly identified/listed in the SAF.
If Test Samples (Hardware)
8. _____ Shipped under a separate cover.
9. _____ The individual test samples (hardware) for evaluation are identified with the AAR# and
part numbers as listed on the assembly matrix.
10. _____ The individual test samples (hardware) for evaluation are referenced on the assembly
matrix.
11. _____ The shipping container/box is marked with the associated AAR# and/or TN.
12. _____ The testing samples (hardware) package includes a packing slip identifying the item(s) and
quantity(ies) shipped.
Fees
13. _____ The application fee check or electronic funds transfer (Pay.Gov) receipt for $200 is
included.
14. _____ The fee check is dated less than 30 days before the submission date of the application.
15. _____ The check is payable to NIOSH.
16. _____ The check includes the EIN, if a U.S. company or subsidiary.
17. _____ The check includes the AAR#.
Assembly Matrix
18. _____ The assembly matrix matches what is listed in the “Reason for Application” section of
the SAF. All applications, except QA Applications, require an assembly matrix.
19. _____ The assembly matrix and SAF represent the actual configuration of the new or modified
approval.
20. _____ The “Reason for Application” accurately reflects what is being requested (e.g. New
Approvals, Extension of Approval, Quality Assurance Approval, Correlation Testing Only,
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Resubmission of New Approval, Resubmission of Extension of Approval, or Amended
Application).
21. _____ R’s are placed in the boxes that are associated with any change to the referenced
components, including drawings, PQP’s, inspection procedures, or any other
documents.
Drawings
22. _____ The necessary new or revised drawings are included in the application documents.
23. _____ The revision levels on all drawings match those listed on the assembly matrix.
24. _____ Item numbers on the exploded-view drawing match the item numbers on the assembly
matrix.
25. _____ All required information is present on the Self-Contained Breathing Apparatus
drawings, as indicated on the appropriate checklists.
Labels
26. _____ All applicable draft approval labels are included with the application (respirator, along
with other labels as required).
27. _____ The assemblies identified on the label match those identified on the matrix (or matrices)
with the possible exception of accessories and User Instructions.
28. _____ The harness labels, primary company, and private label company, if applicable, are
listed and shown on page two of the applicable drawings.
29. _____ All the part numbers on the approval labels match the part numbers listed in the
assembly matrix.
Cautions and Limitations
30. _____ All appropriate cautions and limitations statements are identified on the individual
approvals.
31. _____ All cautions and limitations statements referred to on the approvals are stated on the
label(s).
User Instructions
32. _____ The User Instructions include all the required information e.g. OSHA 1910.134
statement on fit testing, donning instructions, assembly instructions, additional
warnings and cautions, private label statement (as required), name and contact
information of the appropriate company.
Final Review of Application Documents
33. _____ All documents have been verified for the correct revision numbers and the revision
levels match what is listed in the SAF.
34. _____ Pre-submission testing indicating that all performance requirements specified in 42 CFR
Part 84 is provided in the application and is complete.
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6.2 Exploded-View Drawing Checklist for a Self-Contained Breathing
Apparatus or CBRN Self-Contained Breathing Apparatus
1. _____ Drawing contains all major subassemblies and accessories that appear on the
assembly matrix (except the User Instructions and service life plan (as required)).
2. _____ Parts that are obsolete from the matrix should not appear on the exploded-view drawing.
3. _____ The reference numbering on the exploded-view drawing matches the reference
numbering on the assembly matrix. All matrix assemblies are represented on the
exploded-view drawing and there are no extra assemblies on the exploded-view drawing.
For every reference number on the drawing there is a corresponding number on the
matrix, and vice versa.
4. _____ The drawing is properly titled, signed/initialed, numbered, dated, and contains a
revision level.
5. _____ There are no reference dimensions on the drawing.
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6.3 Major Subassemblies Checklist for a Self-Contained Breathing
Apparatus or a CBRN Self-Contained Breathing Apparatus
1. _____ Numbered, titled, signed/initialed by an authorized representative, with an effective
date and revision level.
2. _____ Dimensions: length, width, or diameter, as applicable are referenced.
3. _____ Material specifications or vendor part number is listed.
4. _____ Part number location is listed.
5. _____ Serial number location, if applicable, is listed.
6. _____ Critical and major characteristics must be identified on the drawing or on a separate
document.
7. _____ Inspection procedures or classification of defects are identified on the drawing or in
additional documentation provided with the drawing.
8. _____ Expiration date is indicated, if applicable.
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6.4 Self-Contained Breathing Apparatus or CBRN Self-Contained
Breathing Apparatus
1. _____ Confirm that any materials used in the construction of the respirator which may be
exposed to oxygen pressures above atmospheric pressure are safe and compatible for
the intended use (e.g., exposure to elevated concentrations of oxygen).
Cylinder and Valve
1. _____ Burst disc pressure is given on the drawing, or there is a note that states that it meets
CGA S-1.1 6.3. The requirement is 90-100% of 5/3 service pressure.
• Cylinder fill pressure x 5 ÷ 3 = upper limit.
• Highest pressure x .90 = lower limit.
2. _____ Torque requirement for connection of cylinder valve to cylinder is listed.
3. _____ Cylinder construction (material(s) of construction, fiber reinforced, type of fiber) is
listed.
4. _____ Full cylinder volume at operating pressure: Compressed Air Volume is listed.
5. _____ Markings on cylinder: compressed breathing air, compressed breathing oxygen, liquefied
breathing air, or liquefied breathing oxygen, adhere to DOT marking requirements.
6. _____ Pressure gauge range has a scale reliable to within + or - 5% of full scale (minimum of
five graduations empty, 1/4, 1/2, 3/4, full).
7. _____ Where pressurized oxygen is used, the gauge must have the words “oxygen” and
“use no oil.” Also, if it is a closed-circuit unit with oxygen, all materials must be
compatible for use with oxygen.
8. _____ Procedure to assure proper gas mixture for refill purposes (percent oxygen) is included.
Applies to specialty gases only; does not apply to grade D air.
9. _____ Specification and dimensions of outlet threads are listed.
Respiratory Inlet Covering (Facepiece or Hood)
1. _____ If a pressure-demand valve is present, shows it is spring loaded.
2. _____ Lens meets impact resistance GGG-M-125d Oct. 11, 1965 (amended July 30, 1969).
3. _____ Lens has statement if antifog is needed or not.
4. _____ Statement to indicate if and when nosecup assembly is needed.
Backpack Harness Assembly
1. _____ Inspection procedures or classification of defects include a visual inspection of
the buckles is included.
2. _____ Location of NIOSH harness label is indicated.
Pneumatic Assembly
1. _____ For all compressed gas SCBA, a statement that it has an inline filter downstream of the
air source that will effectively remove particles from the gas stream (42 CFR Section
84.87).
2. _____ Type of connections on SAR hose (for an SCBA/SAR combination) is listed.
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3. _____ Pressure gauge range has a scale reliable to within + or - 5% of full scale (minimum
of five graduations: empty, 1/4, 1/2, 3/4, full).
4. ______ When pressurized oxygen is used, gauge has the words “oxygen” and “use no oil.”
5. _____ Statement showing all SCBA components critical to the performance of the
respirator will function at the minimum temperature, including seals and O-rings (42
CFR Section 84.98).
6. _____ Statement as to how the remote pressure gauge is attached, i.e., Loctite® or torque is
listed.
7. _____ Parts list showing all parts and materials of the pneumatic assembly.
First Stage Regulator
1. _____ Intermediate Pressure Range is listed.
2. _____ Regulator is designed to fail in the open position.
Second Stage Regulator Assembly
1. _____ Parts list showing all parts and materials of the regulator is included.
2. _____ If a belt mounted regulator assembly, a pressure relief valve is required along with a
statement of diaphragm over-pressurization requirement.
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6.5 Supplied-Air Respirator
Respiratory Inlet Covering (Facepiece/Hood/Helmet)
1. _____ Lens has statement on impact resistance GGG-M-125d, Oct. 11, 1965 (amended July
30, 1969). Does not apply to types A, AE, B, and BE.
Air Supply Valve/Orifice/Demand or Pressure-Demand Regulator
1. _____ Parts list required showing all parts that make up the air supply valve/orifice/regulator.
Hose/Couplings
1. _____ Couplings must be specified by both type and manufacturer, even if the type is a
manufacturer name (example: Foster-Schrader which we would interpret to be a
Schrader style/compatible coupler manufacturer by Foster). The specific model or part
number must be identified; it cannot be listed as “or equivalent.”
2. _____ Maximum pressure rating of hose.
Breathing Tube
1. _____ Inspection procedures or classification of defects include a method for checking the
clamps on the breathing tube.
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6.6 Private Label Checklist for a Self-Contained Breathing Apparatus
or a CBRN Self-Contained Breathing Apparatus
1. _____ An assembly matrix showing private label version under current approval (TC) number is
included.
2. _____ If private label SCBA is a different model/part number than primary approval holder’s
number, part number and description are in a new separate column on the matrix.
3. _____ If the private label is the same model/part number as the primary approval holder’s
model/part number, the approval holder name and private label company name are in
the description column of the primary Self-Contained Breathing Apparatus model/part
number.
4. _____ The harness private label is included on page two of the drawing.
5. _____ The harness label is included on page two of the drawing.
A. _____ Abbreviated/Harness label must include the following items:
a. Private label company name.
b. NIOSH is printed in block letters.
c. Appropriate approval (TC) number(s).
d. Model or part number.
e. Cautions and limitations.
B. _____ A draft of the full private label approval label is included and includes
cautions and limitations special “S.”
C. _____ Private label User Instructions are included.
D. _____ “S” Special User Instructions section is required with the statement:
Model nnnn Self-Contained Breathing Apparatus has been
manufactured by approval holder xxx for private label company yyyy
under TC-13F-nnnn or TC-13F-CBRN-nnnn.
E. _____ Contact information and a contact person must be identified either in the
application or on a separate sheet.
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6.7 Assembly Matrix Checklist for a Self-Contained Breathing Apparatus
or a CBRN Self-Contained Breathing Apparatus
This checklist corresponds to the Example Assembly Matrix in Section 7.2
1. _____ The title of the document is indicated on the top of the page.
2. _____ The assembly matrix has the following information in the top right corner of the page:
a. Title.
b. Applicant’s name and address.
3. _____ The following is indicated below the key box:
a. Date.
b. Revision level, if applicable.
4. _____ New drawings submitted with the application or the drawing revision level reflects the
current revision level on file at NIOSH. If the drawing has changed from what is currently
on file at NIOSH, the altered drawing needs submitted with the appropriate revision
level noted. If the drawing is within another application at NIOSH, this information must
be identified in the “Reason for Application” section.
5. _____ The numbering system used for assemblies shown on the matrix and exploded-view
drawing match.
6. _____ The part number marked on the component must appear in the part number row
(model numbers optional).
7. _____ Features that describe the respirator are not listed as a separate column on the matrix.
Features associated with specific model numbers may be coupled together in the
description (e.g., Model 1201 with Quick Attachment cylinder).
8. _____ Top row (A) must be a general category, i.e., facepiece, etc. Accessories must be
included. “Alternate” will be in the column heading if there are more than one of the
same assemblies.
9. _____ The NIOSH TN (B) where the component was last tested is listed in the bottom row. If
new, indicate N.
10. _____
The AAR# (C) appears in the first column from the left.
11. ____
_
The TC number (D) appears in the second column from left.
a. A new TC number is listed in the proper format: schedule# and AAR# followed
by an alpha character.
b. List “TC-” only in the category heading.
12.
_____ The list of protections (E) appears in the third column from left.
a. Verify the list matches the protections listed in the SAF. See the complete list of
protections and cautions and limitations.
13. _____ The key box (F) must use only the characters X, N, P, R, -, or A.
14. _____ TN/AAR# of the previously approved/pending matrix (G) is noted above the right-hand
side of the table.
15. _____ Current exploded-view drawing number (H) and revision is located directly below the
TN/AAR# of the previously approved/pending matrix.
16. _____ A column for the part number/revision level of the User Instructions must be used.
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Section 7 - Document Examples for a Self-Contained Breathing
Apparatus or a CBRN Self-Contained Breathing
Apparatus
7.1 Example of a Product Quality Plan for Self-Contained Breathing
Apparatus or CBRN Self-Contained Breathing Apparatus
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Double Wing Manufacturing
123 Manufacture Lane
Pittsburgh, PA USA
Phone: 412-555-1212
TN or AAR# of previously approved or pending Matrix: N/A
N/A see exploded-view drawing for each respirator configuration
Exploded-view drawing number: DWM005
(G)
(H)
(F)
7.2 Example of an Assembly Matrix for a Self-Contained Breathing
Apparatus
K
ey:
X=Currently Approved in this Configuration
N=New Component or Configuration
"-"=Obsolete
R=Redesign/Revision
P=Pending
A=Accessory
D
ate: August 15, 2015
Revision: 0
Item 4 6 2 3 8 9
Revision 0 1 2 2 1 2 2 0
Drawing
Number
PRI PG001 SS0
1 H01 CM002 LN001 CS01 N/A
Descript
ion
First
Stage
Re
gulator
Remote
Guage
and
P
ASS
Unit
Mask
Mount
Re
gulator
Interior
Hose
Control
Module
Lens Case
Instruct
ions
Ca
(D)
Protection
(E)
Part
Number
100 200 300 H95 H99 FR333 PG004 C01 C02 C03 C04 R333 IH333 CM001
LENS
10
CASE
20
Instruct
ions
13F-
AARa
30 min/
2216 psi/
SC
/PD
FF 100
SCBA
N N N N N N N N N N N N N
13F-
AARb
30 min/
4500 psi/
SC
/PD
FF 100
SCBA
N N N N N N N N N N N N N
13F-
AARc
45 Min/
4500 psi/
SC
/PD
FF 100
SCBA
N N N N N N N N N N N N N
13F-
AARd
30 Min/
4500 psi/
SC
/PD
FF 100
SCBA
N N N N N N N N N N N N N
N N N N N N N N N N N N N N N N N
(B) NIOSH Task Number
Where the Component was
Last Tested (If New,
Indica te a s "N")
Pass/
Gauge
Un
it
Second
Stage
Re
gulator
Control
Module
2
CLDR001
Full
Facepiece
Backframe
and
Har
ness
Compressed Air
Cylinders
Alternate Cylinder
Hose
Accessories
Instruct
ions
2
FP100
0
HR200
Alternate
Harness
Pressure
Reducer
1
7
5
10
(A)
Alternate
Facepiece
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Double Wing Manufacturing
123 Manufacture Lane
Pittsburgh, PA USA
Phone: 412-555-1212
TN or AAR# of previously approved or pending Matrix: N/A
N/A see exploded-view drawing for each respirator configuration
Exploded-view drawing number: DWM005
(G)
(H)
(F)
7.3 Example of an Assembly Matrix for a CBRN Self-Contained Breathing
Apparatus
Key:
X=Currently Approved in this Configuration
N=New Component or Configuration
"-"=Obsolete
R=Redesign/Revision
P=Pending
A=Accessory
Date: August 15, 2015
Revision: 0
Item 4 6 2 3 8 9
Revision 0 1 2 2 1 2 2 0
Drawing
Number
PRI PG001 SS01 H01 CM002 LN001 CS01 N/A
Descript
ion
First
Stage
Regulator
Remote
Guage
and
PASS
Unit
Mask
Mount
Regulator
Interior
Hose
Control
Module
Lens Case
Instruct
ions
Ca
(D)
Protection
(E)
Part
Number
100 200 300 H95 H99 FR333 PG004 C01 C02 C03 C04 R333 IH333 CM001
LENS
10
CASE
20
Instruct
ions
13F-
AARa-
CBRN
30 min/
2216 psi/
SC/PD/EO
STI 33
FF 100
SCBA
N N N N N N N N N N N N N
13F-
AARb-
CBRN
30 min/
4500 psi/
SC/PD/EO
STI 33
FF 100
SCBA
N N N N N N N N N N N N N
13F-
AARc-
CBRN
45 Min/
4500 psi/
SC/PD/EO
STI 33
FF 100
SCBA
N N N N N N N N N N N N N N
13F-
AARd-
CBRN
30 Min/
4500 psi/
SC/PD/EO
STI 33
FF 100
SCBA
N N N N N N N N N N N N N
N N N N N N N N N N N N N N N N N
(B) NIOSH Task Number
Where the Component was
Last Tested (If New,
Indica te a s "N")
Pass/
Gauge
Unit
Second
Stage
Regulator
Control
Module
2
CLDR001
Full
Facepiece
Backframe
and
Harness
Compressed Air
Cylinders
Alternate Cylinder
EBSS
Hose
Accessories
Instruct
ions
2
FP100
0
HR200
Alternate
Harness
Pressure
Reducer
1
7
5
10
(A)
Alternate
Facepiece
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7.4 Example of an Exploded-View Drawing for a Self-Contained Breathing
Apparatus or a CBRN Self-Contained Breathing Apparatus
Item Part Number Description
1
X000
Facepiece
2
R333
Second Stage Regulator
3
IH333
Intermediate Hose
4
FR333
First Stage Regulator
5
C004
Cylinder
6
PG00X
Pass/Gauge Unit
7
HXX
Harness
8
CM001
Control Module
10
ACS01
Accessory
Approved
Double Wing Manufacturing, Pittsburgh, PA
Drawing: DWW 8/25/2015
Part Number: Model
FF100
Title: SCBA FF100
Release: DDW 8/26/2015
Scale: NTS
Revision:
0
Drawing Number DWM005
1
2
3
4
5
6
7
8
10
DWM
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7.5 Example of an Approval Label for a Self-Contained Breathing Apparatus
Double Wing Manufacturing Company
Almost Heaven, West Virginia, USA
1-800-123-4567
1900 Series SCBA
Open-Circuit, Pressure-Demand, Entry, Self-Contained Breathing Apparatus
These Respirators are approved only in the following configurations:
1. PROTECTION
PD - Pressure-Demand
SC - Self-Contained
2.
CAUTIONS AND LIMITATIONS
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA,
OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as
specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of
these respirators.
S Special or critical User Instructions and/or specific use limitations apply. Refer to User Instructions
before donning.
[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions.
This includes cold temperature limitations, air quality requirements, etc. that were listed on old Part 11
label.]
TC-
Protection
1
Cautions
and
Li
mitations
2
1000 2000 3000 4000 H9
5 H96 H97 H98 H99 C001 C002 C003 C004 R111 R222 R333
LENS
10
ALARM
50
CASE
20
13F-
AARa
30 min/
2216 psi/
SC
/PD
X X X X X X X X X X X IJMNOS
13F-
AARb
30 min/
4500
ps
i/SC/PD
X X X X X X X X X X X X IJMNOS
13F-
AARc
45 min/
4500
ps
i/SC/PD
X X X X X X X X X X IMNOS
13F-
AARd
60 min/
4500
ps
i/SC/PD
X X X X X X X X X IJMNOS
RESPIRATOR COMPONENTS
Alternate Facepiece
Alternate Harness
Alternate Cylinder
Alternate
Regulator
Accessories
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7.6 Example of an Approval Label for a CBRN Self-Contained Breathing Apparatus
Double Wing Manufacturing Company
Almost Heaven, West Virginia, USA
1-800-123-4567
1900 Series CBRN SCBA
Open-Circuit, Pressure-Demand, Entry and Escape CBRN Self-Contained Breathing Apparatus
These respirators are approved only in the following configurations:
Respirator Components
TC-
Protection
1
Alternate Facepiece
Alternate Harness
Alternate Cylinder
Alternate
Regulator
Accessories
Cautions
and
Limitions
2/3
10
00
20
00
30
00
40
00
H95
H96
H97
H98
H99
C0
01
C0
02
C0
03
C0
04
R1
11
R2
22
R3
33
Lens
10
Alarm
50
Case
20
13F-
AARa
-CBRN
30 min/
2216 psi/
SC/PD/
EOSTI 33
X
X
X
X
X
X
X
X
X
X
X
IJMNOS,
ORTUEBSS
13F-
AARb
-CBRN
30 min/
4500 psi/
SC/PD/
EOSTI 33
X
X
X
X
X
X
X
X
X
X
X
X
IJMNOS,
ORTUEBSS
13F-
AARc
-CBRN
45 min/
2216 psi/
SC/PD/
EOSTI 33
X
X
X
X
X
X
X
X
X
X
IJMNOS,
ORTUEBSS
13F-
AARd
-CBRN
60 min/
2216 psi/
SC/PD/
EOSTI 33
X
X
X
X
X
X
X
X
X
IJMNOS,
ORTUEBSS
1. PROTECTION
PD - Pressure-Demand EOSTI - End-of-Service-Time Indicator
SC - Self-Contained CBRN - Chemical, Biological, Radiological, and Nuclear
2. CAUTIONS AND LIMITATIONS
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA,
OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as
specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of
these respirators.
S Special or critical User Instructions and/or specific use limitations apply. Refer to User Instructions
before donning.
3. CAUTIONS AND LIMITATIONS OF USE FOR CBRN SCBA
Q Use in conjunction with personal protective ensembles that provide appropriate levels of protection
against dermal hazards.
R Some CBRN agents may not present immediate effects from exposure, but can result in delayed
impairment, illness, or death.
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T Direct contact with CBRN agents requires proper handling of the SCBA after each use and between
multiple entries during the same use. Decontamination and disposal procedures must be followed. If
contaminated with liquid chemical warfare agents, dispose of the SCBA after decontamination.
U The respirator should not be used beyond six (6) hours after initial exposure to chemical warfare
agents to avoid possibility of agent permeation.
EBSS EBSS Activation or engagement of EBSS in either the donor or receiver mode changes the SCBA use to
Escape-Only, approved service time for either the donor, or the receiver.
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7.7 Example of an Approval Label for a Self-Contained Breathing Apparatus and
a Combination SCBA/SAR
Double Wing Manufacturing Company
Almost Heaven, West Virginia, USA
1-800-123-4567
1955 Series SCBA
Open-Circuit, Pressure-Demand, Entry and Escape, Self-Contained Breathing Apparatus
and
Open-Circuit, Pressure-Demand, Entry and Escape, Combination Self-Contained Breathing Apparatus and
Type C Supplied-Air Respirator
These respirators are approved only in the following configurations:
Respirator Components
TC- Protection
1
Alternate
Facepiece
Alternate Harness
Alternate
Cylinder
Alternate
Hoses
Alternate
Regulator
Accessories
Cautions and
Limitations
2
1
0
0
0
2
0
0
0
3
0
0
0
4
0
0
0
H
9
5
H
9
6
H
9
7
H
9
8
H
9
9
C
0
0
1
C
0
0
2
C
0
0
3
C
0
0
4
2
5
5
0
1
0
0
R
1
1
1
R
2
2
2
R
3
3
3
L
E
N
S
1
0
A
L
A
R
M
5
0
C
A
S
E
2
0
13F-AARa
30 min. 2216
psi SC/PD
X X X X X X X X X X X IJMNOS
13F0-AARb
30 min. 4500
psi SC/PD
X X X X X X X X X X X X IJMNOS
13F0-AARc
45 min. 4500
psi SC/PD
X X X X X X X X X X IJMNOS
13F-AARd
60 min. 4500
psi SC/PD
X X X X X X X X X IJMNOS
13F-AARc
30 min. 2216
psi SC/SA/PD
X X X X X X X X X X X X X X DEIJMNOS
1. PROTECTION
PD - Pressure-Demand SC - Self-Contained SA - Supplied-Air
2. CAUTIONS and LIMITATIONS
D Air-line respirators can be used only when the respirators are supplied with respirable air meeting the
requirements of CGA G-7.1, Grade D or higher quality.
E Use only the pressure ranges and hose lengths specified in the User Instructions.
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA,
OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as
specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of
these respirators.
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S Special or critical User Instructions and/or specific use limitations apply. Refer to User Instructions
before donning.
[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions.
This includes cold temperature limitations, air quality requirements, etc. that were listed on old Part 11 label.]
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7.8 Example of an Approval Label for a Self-Contained Breathing Apparatus
Harness
Double Wing Manufacturing Company
Almost Heaven, West Virginia, USA
1-800-123-4567
Easy-Carry SCBA
Open-Circuit, Pressure-Demand, Entry and Escape Self-Contained Breathing Apparatus
TC-13F-XXX 30 MINUTE 2216 PSIG
TC-13F-YYY 30 MINUTE 4500 PSIG
TC-13F-ZZZ 45 MINUTE 4500 PSIG
TC-13F-AAA 60 MINUTE 4500 PSIG
(Refer to the Approved User Instructions for the Complete List
of Components that Make Up the Approved Assembly)
Cautions and Limitations
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with
MSHA, OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the
configuration as specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and
maintenance of these respirators.
S Special or critical User Instructions and/or specific use limitations apply. Refer to User
Instructions before donning.
[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions.
This includes cold temperature limitations, air quality requirements, special use instructions, etc. that were
listed on old Part 11 label.]
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7.9 Example of an Approval Label for a CBRN Self-Contained Breathing
Apparatus Harness
Double Wing Manufacturing Company
Almost Heaven, West Virginia, USA
1-800-123-4567
Model FFCBRN SCBA
Open-Circuit, Pressure-Demand, Entry and Escape Self-Contained Breathing Apparatus
TC-13F-XXXCBRN 30 MINUTE 2216 PSIG
TC-13F-YYYCBRN 30 MINUTE 4500 PSIG
TC-13F-ZZZCBRN 45 MINUTE 4500 PSIG
TC-13F-AAACBRN 60 MINUTE 4500 PSIG
Refer to the Approved User Instructions for the Complete List
of Components that Make Up the Approved Assembly.
Cautions and Limitations
I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.
J Failure to properly use and maintain this product could result in injury or death.
M All approved respirators shall be selected, fitted, used, and maintained in accordance with
MSHA, OSHA, and other applicable regulations.
N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the
configuration as specified by the manufacturer.
O Refer to User Instructions, and/or maintenance manuals for information on use and
maintenance of these respirators.
S Special or critical User Instructions and/or specific use limitations apply. Refer to User
Instructions before donning.
Q Use in conjunction with personal protective ensembles that provide appropriate levels of
protection against dermal hazard.
R Some CBRN agents may not present immediate effects from exposure, but can result in delayed
impairment, illness, or death.
T Direct contact with CBRN agents requires proper handling of the respirator after each use and
between multiple entries during the same use. Decontamination and disposal procedures must
be followed. If contaminated with liquid chemical warfare agents, dispose of the respirator after
decontamination.
U The respirator should not be used beyond 6 hours after initial exposure to chemical warfare
agents to avoid possibility of agent permeation.
[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions.
This includes cold temperature limitations, air quality requirements, special use instructions, etc. that were
listed on old Part 11 label.]
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Section 8 - Label Format Guidance
• Labels for Self-Contained Breathing Apparatus and CBRN Self-Contained Breathing Apparatus must be
completed in the assembly matrix format shown in the preceding examples.
• The TC number is listed in the far left column. For initial submittals the TC number is the schedule and
AAR# followed by an alpha character, exactly as in the assembly matrix. This links the approval label to
the application and assembly matrix. Upon approval, NIOSH will insert the TC number. “TC-” can only
appear in the column heading, not in the row.
• Protections are the second column from the left.
• Cautions and limitations are the far right column.
• The component columns must list all of the major assemblies and accessories and can be in any order
that the applicant chooses.
• Anytime more than one of the same assemblies for a respirator configuration are listed on the
approval label, they must be identified as alternate components by adding “Alternate” to the column
heading. X is the only character that may be used in the body of the approval label to designate an
approved component.
• If a component is offered as an accessory, the category must be labeled as “accessory” (e.g.,
“Accessory Cover").
• Empty rows are not permitted. Approval labels must not be color coded.
• Wording of the standard protections and cautions and limitations must be identical to the NIOSH
samples. Only appropriate cautions and limitations may be listed. For example, if only cautions and
limitations A, C, and G apply, then only A, C, and G can be footnoted at the bottom of the label.
• The SCBA harness label must clearly indicate the approval holder’s name, address, and phone number,
model/trade name, type of protection, TC number, duration-cylinder pressure-type data, appropriate
cautions and limitations, reference to the User Instructions for major subassembly and component
information, and HHS and NIOSH logos.
• The entire SCBA or SAR label must appear in the User Instructions.
• Protections on SCBA approval labels, User Instructions and assembly matrices must list the cylinder
operating pressure, rated service time, and self-contained code e.g., 2216 psig 30 min SC. Protections
are to include the End-of-Service-Time Indicator version (EOSTI-25 or EOSTI-33).
• If all respirators on the label are of the same series or family, text may be added to identify the
respirator series or family, e.g., continuous flow, pressure-demand, positive pressure, Type C or Type
CE, open-circuit, closed-circuit, etc. This heading is optional on all approval labels.
• Non-NIOSH approval identifiers cannot be represented on any NIOSH labels. Applicants may use
additional areas on the component to identify any other applicable approvals such as the European CE
approval. However, this information must be separated from the NIOSH approval label.
• If the label will not fit on the container, it must be included inside the container. If the label is inserted,
the container must say “NIOSH-Approved - see insert.” The insert may consist of the approval label or
the User Instructions containing the approval label.
• If the respirator is for escape-only, the applicant must use the word escape on full approval labels. For
example, “These escape-only respirators are approved only in the following configurations.” ‘Escape’
may be abbreviated in the protection column but must be spelled out in the legend. “Esc” is the only
acceptable abbreviation for escape.
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APPENDIX
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Centers for Disease Control
and Prevention (CDC)
National Institute for Occupational
Safety and Health (NIOSH)
National Personal Protective
Technology Laboratory (NPPTL)
P.O. Box 18070
Pittsburgh, PA 15236
Phone: 412-386-4000
Fax: 412-386-4051
September 24, 2012
LETTER TO ALL RESPIRATOR MANUFACTURERS
Subject: Sampling Procedures
The National Institute for Occupational Safety and Health (NIOSH) requires that respirator approval
holders inspect and/or test samples of respirators and components as part of their quality control
plans. This requirement is stated in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84),
specifically in §§ 84.41(b) through 84.41(i). Some applicants or approval holders have had difficulty
understanding how to select and use a sampling procedure which meets the requirements. This
letter is intended to explain the practical use of common standard procedures acceptable to NIOSH.
This letter will not discuss statistical theory underlying acceptance sampling. If applicants or
approval holders intend to use alternatives to the procedures described here, they must understand
the concepts of acceptance sampling and process control. The use of more modern methods such as
calculating process capability values (Cpk) or employing statistical process control (SPC) is
encouraged where this is compatible with the approval holder’s operations and provides equivalent
assurance of respirator performance. Justification to demonstrate the equivalence of these
procedures must be provided in the application seeking approval.
1. Selection of Sampling Procedures
1.1 Sampling by Variables. The standard sampling procedure specified in 42 CFR Part 84 is MIL-STD-
414 [U.S. Department of Defense 1957]. This is a variable sampling plan, which means that the
characteristic must be something that can be measured numerically on a continuous scale.
Examples include the diameter of a hole in inches, the mass of a cartridge in grams, or the leakage
of an exhalation valve in milliliters per minute. This procedure is only valid when the characteristic
being measured has a statistically normal distribution over the population being sampled. The
ANSI/ASQ Z1.9 standard [American National Standards Institute 2003b] is derived from MIL-STD-
414, and NIOSH considers it to be equivalent.
1.2 Sampling by Attributes. The MIL-STD-105D sampling procedure [U.S. Department of Defense
1963] is explicitly accepted as an equivalent procedure in 42 CFR Part 84. This is an attribute sampling
plan, which means that each characteristic is simply checked to see whether it is acceptable. Due to
its simplicity, this standard and its derivatives are by far the most common in use. It has the
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advantage that it can be applied to characteristics which do not involve a numerical measurement
(such as visual checks) as well as to those that are measurable. No calculations are needed to
determine acceptance, and the procedure is valid whether the Page 2 – Letter to All Respirator
Manufacturers 9-2012 characteristic has a normal distribution or not. Typically the sample sizes will
be larger than the corresponding variable sampling plan. Procedures derived from this standard, and
which NIOSH considers to be equivalent, include MIL-STD-105E [U.S. Department of Defense 1989]
and ANSI/ASQ Z1.4 [American National Standards Institute 2003a].
1.3 Zero-Defect Sampling by Attributes. Another attribute sampling plan which NIOSH accepts as equivalent
is the Squeglia C=0 procedure [Squeglia 2008]. While not directly derived from MIL-STD-105E, its plans are
matched to that procedure and provide an acceptable statistical assurance of lot quality. The chief difference
is that in all cases, the lot is only accepted if there are zero defects found in the sample (C=0). This procedure
usually requires fewer samples than MIL-STD-105D and related standards, and is the simplest to use of those
listed in this letter. However, it is generally only suitable when defects in production are extremely rare.
1.4 Equivalent Standards. The ANSI/ASQ standards mentioned above are revised periodically. In general,
NIOSH will consider later editions of a given procedure to be equivalent. There may also be other national or
international standards based on MIL-STD-414 or MIL-STD-105D that can be considered equivalent. If such a
standard is used, NIOSH may request a copy from the applicant to verify its equivalence.
1.5 Obtaining Sampling Procedure Documents. One feature of MIL-STD plans is that as works of the United
States Government, they may be copied free of charge. Those mentioned can be downloaded from the
Internet Archive at http://www.archive.org/ and may be available elsewhere. However, all MIL-STD
documents in this letter have been cancelled by the Department of Defense and are no longer maintained or
revised. The corresponding ANSI/ASQ standards are successors to the MIL-STD documents and have various
minor improvements and clarifications added. Copies of these standards may be purchased from the
American Society for Quality, the American National Standards Institute, or others who deal in national
standards.
2. Acceptable Quality Level (AQL)
• Meaning of AQL. The acceptable quality level is an indicator of the percent defective that
can be
considered satisfactory for a particular characteristic. Smaller AQL values mean that
fewer defectives
will be tolerated in an acceptable lot.
• Selection of AQL. The classification of defects document submitted with each application as required
by 42 CFR Section 84.41(c) through 84.41(e) must identify the severity level of each
characteristic. The
AQL to be used for sampling is shown in the table below and is defined in 42 CFR Section 84.41(g). The
AQL value does not depend on lot size or any other factor, and it is generally
improper to modify the
AQL for any reason other than the defect classification.
1
These are called “index values” in the Squeglia C=0 procedure.
Defect Classification
AQL
1,2
Major A
1.0
Major B
2.5
Minor
4.0
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2
It is acceptable to use a smaller (more stringent) AQL value.
2.3 Critical Characteristics. Characteristics identified as Critical in the classification of defects
are not
assigned an AQL and are not eligible for any form of sampling. Each item made must be
100% inspected as
required by 42 CFR Section 84.41(f) and the entire lot rejected when a defect is
found. Any plans to perform
rework on the lot must be approved as part of the product quality
plan.
2.4 Cross-References. See MIL-STD-414 section A4; ANSI/ASQ Z1.9-2003 sections A2.1, A4; MIL-STD-105D
section 4; MIL-STD-105E sections 3.1, 4.4; ANSI/ASQ Z1.4-2003 section 4;
Squeglia C=0 pages 3, 6.
3. Inspection Level
3.1 Meaning of Inspection Level. The inspection level decides the number of samples to be
drawn for a
particular lot size and determines the sampling plan’s ability to discriminate between
conforming and
nonconforming lots. Lower inspection levels increase the risk that a
nonconforming lot will be accepted.
3.2 Selection of Inspection Level. The inspection level to be used is shown in the “normal”
column of the
table below and is defined in 42 CFR Section 84.41(h). As a special exception, NIOSH is
permitted under 42
CFR Section 84.41(i) to allow a lower inspection level for destructive testing only. The minimum level NIOSH
will accept under this exception is in the “destructive” column. Approval of a level lower than the “normal”
level is entirely at NIOSH’s option and will only be
granted if the rest of the inspection plan ensures
adequate control over product quality.
1
Only permitted with specific prior approval from NIOSH.
The Squeglia C=0 procedure does not use the concept of inspection levels and NIOSH treats it as equivalent
to inspection level II of MIL-STD-105D.
3.3 Cross-References. See MIL-STD-414 section A7.1; ANSI/ASQ Z1.9-2003 section A7.1; MIL-STD-105D
sections 9.2, 9.3; MIL-STD-105E sections 4.9.1, 4.9.2; ANSI/ASQ Z1.4-2003
sections 9.2, 9.3.
4. Normal, Reduced, and Tightened Inspection
4.1 Use of Switching Rules. Most sampling procedures referenced in this letter contain rules
allowing
reduced inspection under certain conditions. Reduced inspection may be used only
when all conditions
listed in the switching rules are met. This includes the requirement that
production is not irregular or
delayed. A history of lot acceptance at one manufacturing site cannot be used to move to reduced sampling
at another site. Approval holders may choose to
stay at normal inspection even when conditions for
reduced inspection are met. However,
tightened
inspection is not optional and must be used where
specified by the rules. The Squeglia
C=0 procedure does not recommend switching rules, and reduced
Procedure
Minimum Inspection Level
Normal
Destructive
1
MIL-STD-414
IV
I
ANSI/ASQ Z1.9-2003
II
S-3
MIL-STD-105D
II
S-2
MIL-STD-105E
II
S-2
ANSI/ASQ Z1.4-2003
II
S-2
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inspection is not permitted by NIOSH for that procedure. Tightened inspection is not required for the
Squeglia C=0 procedure.
4.2 Records to Support Reduced Inspection. To use reduced inspection, the approval holder
must
maintain inspection records showing that the conditions in the applicable procedure are
met. Such
records must be available for review during NIOSH on-site audits.
4.3 Cross-References. See MIL-STD-414 sections A8, B14, C14, D14; ANSI/ASQ Z1.9-2003
section A10; MIL-
STD-105D section 8; MIL-STD-105E sections 4.6, 4.7, 4.8; ANSI/ASQ Z1.4-2003 section 8; Squeglia C=0
pages 14, 16.
5. Lots or Batches
5.1 Definition of Lot. Each procedure listed in this letter requires that product be grouped into
inspection
lots (the term “batch” means the same as “lot”). Each lot consists of product which
has been manufactured
under essentially the same conditions in the same production facility and
at essentially the same time. For
example, if a production line is shut down for a week for maintenance, it is wrong to consider product made
before and after the shutdown as part of the
same lot.
5.2 Selection of Samples from Lot. Each sample drawn from a lot must be representative of the
lot. For
example, when drawing a sample of 200 pieces from a lot of 10,000 it would be
improper to select the first
200 respirators produced to use as the sample. As another example, if
respirators being produced on five
machines are being combined into an inspection lot, then one-
fifth of the sample drawn must come from
each machine. As noted in section 6.2 of this letter,
each sample taken for double or multiple sampling must
be representative of the whole lot.
5.3 Inspection Lot vs. Other Lot Designations. The grouping of finished respirators into lots for shipment or
other purposes may differ from the grouping used for inspection. The lot number
marked on the respirator
or its container, as required by 42 CFR Section 84.33(g), does not necessarily
need to be the same number
used for inspection purposes. However, the approval holder must
maintain traceability between lot
numbering systems if more than one is used. For example, a
shipping lot number must be traceable to the
corresponding production lot number (or numbers).
5.4 Cross-References. See MIL-STD-414 sections A5, A7.2; ANSI/ASQ Z1.9-2003 sections
A2.4, A5, A7.2;
MIL-STD-105D sections 5, 7.2; MIL-STD-105E sections 3.12, 3.13, 4.3, 4.5.1;
ANSI/ASQ Z1.4-2003 sections 5,
7.2; Squeglia C=0 page 2.
6. Specific Considerations for Attribute Plans
6.1 Following Arrows to Select Appropriate Sampling Plan. Where the sampling plan indicated
leads to an
arrow in the table, follow the arrow to the next available sampling plan. This will point to a new code letter
row in the table with the acceptance and rejection numbers and a new
corresponding
sample size to be
used.
As an example, consider sampling of a lot of 200 pieces under MIL-STD-105D for a Major A characteristic at
inspection level II. Code letter G is selected from Table I, and an AQL of 1.0 is
used. An arrow pointing
downward is contained in Table II-A for these conditions, indicating
that code letter G is not available and
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code letter H must be used. This means that the
appropriate sample size is 50 pieces, not 32, and that the
lot is accepted if there are 0 or 1 defective pieces, and rejected if there are 2 or more defectives.
6.2 Single, Double, or Multiple Sampling. Most attribute procedures include double or multiple
sampling
plans (the Squeglia C=0 procedure only has single plans). Any of these options
included in the procedure
may be selected. Note that each sample drawn must be representative
of the entire lot. Double and
multiple sampling tend to require fewer samples when lot quality is
either much better or much worse than
the AQL. Single sampling is simpler to administer and
apply correctly than double or multiple sampling and
is the overwhelmingly popular choice.
As an example, consider a lot of 200 pieces under MIL-STD-105D for a Minor characteristic at
inspection
level II. Code letter G is selected from Table I, and an AQL of 4.0 is used. For single
sampling, Table II-A
indicates that the sample size is 32. The lot is accepted if there are 3 or fewer defective pieces, and it is
rejected if there are 4 or more defectives. For double sampling,
Table III-A is used instead and an initial
sample of 20 would be drawn. The lot is accepted if
there are 0 or 1 defectives, and it is rejected if there are
4 or more defectives. If there are 2 or 3 defectives, then a second sample of 20 is drawn from the lot and
inspected. If after both samples
(totaling 40 pieces) are inspected there are a total of 4 or fewer defectives,
then the lot is
accepted; if 5 or more defectives, then the lot is rejected. Multiple sampling (Table IV-A)
works in a similar fashion, except that there are up to seven rounds of sampling to reach a decision.
6.2.1 Cross-References. See MIL-STD-105D sections 7.4, 9.5, 10.1.1, 10.1.2, 10.1.3;
MIL-STD-105E
sections 4.5.3, 4.9.4, 4.10.1.1, 4.10.1.2, 4.10.1.3; ANSI/ASQ Z1.4-2003
sections 7.4, 9.5, 10.1.1,
10.1.2, 10.1.3.
7. Specific Considerations for Variable Plans
7.1 Variability Unknown vs. Variability Known. A variability unknown method should
normally
be used.
The variability known method may only be used when the production process is under strict control and the
process parameters influencing final respirator performance are
well understood. Data must be provided
with the application for approval, available during on- site audits, and continuously updated to support the
standard deviation value (σ) used.
7.2 Single Specification Limit vs. Double Specification Limit. This is selected on the basis of whether there
is only one limit value (such as penetration less than or equal to 5%) or two limit
values (such as cartridge
mass between 95 and 105 grams) for the characteristic.
7.3 Standard Deviation Method vs. Range Method. Either method may be selected. The
standard deviation
method generally requires fewer samples, but more complex computations.
7.4 Form 1 vs. Form 2. The two forms are equivalent and either one may be selected. Form 2 is
recommended as it yields figures which must be calculated anyway to satisfy the switching rules.
7.5 Cross-References. See MIL-STD-414 Introduction, section A6.2; ANSI/ASQ Z1.9-2003
Introduction,
section A6.2.
8. Scope
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86
8.1 Limitation to Approved Quality Control Plans. Approval holders may perform additional
testing and
inspection not listed in their approved quality control plans. Sampling for these
additional inspections is
not required to meet the requirements set forth in 42 CFR Part 84 and this
letter. However, there must
be a reasonable basis for selecting the sampling plans used.
8.2 Limitation to Required Testing. In some cases, applicants may wish to list testing and
inspection in their
quality control plans above that required by NIOSH for effective quality
control of respirator performance.
Sampling done for these additional inspections is not required
to meet the requirements in 42 CFR Part 84
and this letter. Additional testing should be identified
clearly, such as with the notation “additional
inspection,” on documents submitted with the
application to avoid delay and requests for clarification
during processing. Any such testing
listed in the approved quality control plan must be conducted as
required by 42 CFR Section 84.42(c).
9. Common Errors
9.1 Selection of Inadequate Inspection Levels. The minimum acceptable inspection level is
described in
section 3.2 of this letter. If a product quality control plan does not specify
inspection levels, NIOSH assumes
that the level in the “normal” column of the table will be
used. Use of lower levels without specific
approval, whatever the reason, is a failure to conform
to NIOSH requirements and can result in revocation of
approval under 42 CFR Section 84.43(c).
9.2 Selection of Plan Based on Desired Sample Size. It is entirely improper to choose a desired
sample size
and work backwards to identify a proposed AQL and inspection level which will
yield this result. To do so
reflects a fundamental misunderstanding of the basis for sampling
plans. The appropriate AQL and
inspection level are stated in sections 2.2 and 3.2 of this letter.
9.3 Selection of Defect Classification Based on Desired AQL. As in 9.2, the defect classification
drives the
selection of AQL, not the other way around. Each defect must be classified based
solely on the definitions in
42 CFR Section 84.41(d).
9.4 Modification of AQL or Inspection Level Based on Lot Size or Other Factors. The AQL and
inspection level
are chosen by the criteria in sections 2.2 and 3.2 of this letter. Approval holders
are free to use higher
inspection levels if greater discrimination is desired, or to use lower (more
stringent) AQLs if a smaller
percent defective is desired. However, these should not be modified
based on lot size or inspection history,
as provisions already exist to account for those factors.
Changing AQL values or inspection levels is likely to
result in a statistically invalid plan.
9.5 Inappropriate Use of Reduced Inspection. As described in section 4.1 of this letter, reduced
inspection is
permitted only when all conditions of the relevant procedure are met. When there
are significant delays or
changes in production processes, approval holders must revert to normal
inspection. It will be considered a
nonconformance during NIOSH on-site audits if the records
described in section 4.2 of this letter are not
available.
9.6 Incorrect Sample Size When Following Arrows in Sampling Tables. When using attribute
sampling, be
careful when following arrows in the sampling plan tables. A different sample size
must be used to
correspond with the new code letter as described in section 6.1 of this letter.
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9.7 Improper Drawing of Samples. Each sample drawn must be representative of the entire lot as described
in section 5.2 of this letter. The typical method is to select samples at random.
However, other methods
(such as every tenth piece) may be used so long as the sample is not
biased in any way as a result. If a lot
contains multiple sublots, the sample must contain a
proportional number of pieces from each sublot.
10. References
American National Standards Institute [2003a]. Sampling procedures and tables for inspection
by
attributes. Milwaukee, WI: American Society for Quality, American National Standard
ANSI/ASQ Z1.4-2003.
American National Standards Institute [2003b]. Sampling procedures and tables for inspection
by variables
for percent nonconforming. Milwaukee, WI: American Society for Quality,
American National Standard
ANSI/ASQ Z1.9-2003.
Squeglia NL [2008]. Zero acceptance number sampling plans. 5th ed. Milwaukee, WI:
American Society for
Quality.
U.S. Department of Defense [1957]. Sampling procedures and tables for inspection by variables
for percent
defective. Washington, DC: Office of the Assistant Secretary of Defense (Supply and Logistics), Military
Standard MIL-STD-414 (including Notice 1, 8 May 1968).
U.S. Department of Defense [1963]. Sampling procedures and tables for inspection by attributes.
Washington, DC: U.S. Government Printing Office, Military Standard
MIL-STD-105D (including Change Notice 2, 20 March 1964).
U.S. Department of Defense [1989]. Sampling procedures and tables for inspection by attributes.
Washington, DC: Department of Defense, Military Standard MIL-STD-105E.
For further information regarding sampling, contact Vance Kochenderfer via electronic mail at
or by telephone at 412-386-4029. General inquiries may be directed to the
Technology Evaluation Branch at
npptl@cdc.gov or 412-386-4000.
S
incerely yours,
H
einz W. Ahlers
Chief, Technical Evaluation Branch
National Personal Protective Technology Laboratory
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DEPARTMENT OF HEALTH & HUMAN SERVICE Public Health Service
Centers for Disease Control
and Prevention (CDC)
National Institute for Occupational
Safety and Health (NIOSH)
National Personal Protective
Technology Laboratory (NPPTL)
P.O. Box 18070
Pittsburgh, PA 15236
Phone: 412-386-4000
Fax: 412-386-4051
April 7, 2005
L
ETTER TO ALL RESPIRATOR MANUFACTURERS
S
ubject: Clarification of Supplier and Subcontractor Relationships
B
ackground
Nat
ional Institute for Occupational Safety and Health (NIOSH or the Institute) approval holders have established
relationships with suppliers and subcontractors who are manufacturing
,
components or subassemblies for
approved respirator configurations. A growing number of
approval holders wish to ship NIOSH-Approved
respirators directly from a subcontractor to distribution centers or customers, and replacement parts directly to
a repair center. The Institute
has identified two possible approval holder relationships with suppliers and
subcontractors. Listed below are the responsibilities and requirements NIOSH has established for these
relationships.
D
efinitions
Approval Holder:
The party of record to whom certificates of approval have been issued. The
approval holder maintains
responsibility for, and control of, product design, performance, configuration management, manufacture,
quality, and support.
S
upplier:
A supplier produces components or subassemblies under their own quality
system for delivery to the approval
holder. The approval holder confirms the acceptability of incoming goods by accepting a Certificate of
Compliance and inspecting incoming goods to ensure compliance with all
product design, performance, and
Quality Assurance criteria (drawings and engineering control). The approval holder releases the product for
distribution and sale.
S
ubcontractor:
The a
pproval holder may authorize a subcontractor to release NIOSH
-
approved respirators directly from their
facility for distribution and sale, or
to release components and subassemblies directly to an authorized repair
center. The approval holder maintains responsibility for, and control of,
product design, performance,
configuration management, manufacture, quality, and support by maintaining influence over, and active
involvement in, the subcontractor's quality system. As such, the subcontractor's facility
is considered to be a
manufacturing site for the approval holder.
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Page 2 -Letter to All Respirator Manufacturers
Subcontractor Relationship Responsibilities
The approval documentation on file at NIOSH must demonstrate that the following criteria have been
met for NIOSH recognition of a subcontractor.
-
As with all other NIOSH approvals, the approval holder maintains responsibility for all aspects
of the approval: control over product drawings, material specifications, parts
lists, and
manufacturing processes; control over the requirements for final inspection and
testing; and
approval of any changes to the above.
- The approval holder must assure that a subcontractor has demonstrated the ability to
supply
product that consistently meets the established release criteria, and has adequate
quality
systems and procedures in place to assure product quality on an ongoing basis.
-
The approval holder must establish and maintain active involvement and influence over
subcontractor qu
ality systems. This can be demonstrated in many different ways. One
example of th
is involvement and influence can be exhibited by participating in the
subcontractor's management reviews (as defined by ISO 9001, 2000, section 5.6)
required by
the subcontractor's Quality System. A second example is participation in the subcontractor's
Material Review Board.
-
The approval holder's methods for maintaining active involvement and influence over
their
subcontractor's quality system needs to be documented in a plan or procedure that suits the
individual situation and manufacturing complexity of the secured goods. This
plan or
procedure must be formally submitted to NIOSH.
- The approval holder will maintain copies of subcontractor quality records that
demonstrate
compliance with NIOSH performance requirements. It is important to
assure that, in the
event of a broken relationship, both the Approval Holder and NIOSH
have continued access to
those records.
-
All submissions related to the approval must be made by an authorized representative of
the
approval holder. The subcontractor's Quality Manual and related quality system
documents
must represent how the approval holder establishes and maintains active
involvement and
influence over the subcontractor's quality system. This information
must be specifically
indicated and documented as part of a Quality Assurance
Application. As wi
th all Quality Manuals, a process must be established and followed for
ongoing
resubmission of the Quality Manual and related quality system documents in the
event of
significant changes, and on a periodic basis, per NIOSH requirements.
-
All subcontractor relationships must
be
listed as an approval holder's manufacturing site, with a
designated point of contact, on the NIOSH Standard Application Form (SAF) for direct shipment
from the subcontractor to be acceptable under the NIOSH Approval.
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Page 3 - Letter to All Respirator Manufacturers
- All manufacturing sites for NIOSH-Approved products, including subcontractor facilities, will
be audited by NIOSH on a regular basis. The Institute will not contact the
subcontractor
directly, but will always work through the approval holder's designated representative for
the specific manufacturing site.
S
incerely yours,
Hei
nz W. Ahlers
Acting Branch Chief
Respirator Branch
National Personal Protective Technology Laboratory
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Definitions
The following definitions are provided for clarification of terms used in these procedures:
Accessory - An item provided with a respirator that does not affect the respirator’s ability to meet the
requirements of 42 CFR Part 84. The approval remains effective whether or not the accessory is used.
Alternate Contact - A contact designated by the prospective approval holder that can interface with
NIOSH regarding applications and other NIOSH business such as audits and product investigations.
Amended Application - An application submitted at NIOSH’s request that shows changes to correct an
inaccuracy detected during the NIOSH application evaluation. The Applicant-Assigned Reference
Number (AAR#) and Task Number (TN) will remain the same.
Applicant - The individual, partnership, company, corporation, association or organization that designs,
manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate
of approval for such respirator.
Applicant-Assigned Reference Number (AAR#) - A unique identifying number of the applicant’s
choosing. The number must start with the three character manufacturer’s code. The AAR# must never
be reused.
Approval - A certificate or formal document issued by the Institute (in this instance NIOSH) stating that
an individual respirator or combination of respirators has met the minimum requirements of this part
(42 CFR 84), and that the applicant is authorized to use and attach an approval label to any respirator,
respirator container, or instruction card for any respirator manufactured or assembled in conformance
with the plans and specifications upon which the approval was based, as evidence of such approval.
Approval Holder - The entity to which a certificate or formal document has been issued by NIOSH
stating that an individual respirator or combination of respirators has met the minimum requirements
of 42 CFR Part 84. The approval holder is authorized to use and attach an approval label to any
respirator, respirator container, or instruction card for any respirator manufacturers or respirator
assembled in conformance with the plans and specifications upon which the approval was based.
Approval Labels - The label that is attached to the respirator, container, instructions, or packaging
once approved by NIOSH. All major subassemblies in the approved respirator configuration must be
on the approval label. Accessories may be listed on the approval label, but are not required.
Assembly Matrix - A diagram of all major subassemblies and accessories that apply to approvals in a
respirator family. Components are identified by category, description, drawing number and revision,
part number, and applicability to the listed approvals.
Authorized Representative - The person responsible for completing and submitting the Standard
Application Form to NIOSH. This person can be an employee of the prospective approval holder or an
independent consultant hired by the company to complete the Standard Application Form. Designated
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by prospective approval holder to interface with NIOSH regarding applications and other NIOSH
business such as audits, and product investigations.
Belt Mounted - An air-purifying canister, chemical cartridge, or particulate filter or an air-supplied
regulating valve or regulator that is mounted on the user’s belt with an adaptor.
Canister - A gas or vapor removing component which meets the requirements of 42 CFR Part 84,
subpart I, Tables 5, 6, and 7 only. Canisters may incorporate particulate filters and can be used for
escape from immediately dangerous to life or health environments, which sufficient oxygen. Usually
approved with under schedule 14G respirators.
Cartridge - A gas or vapor removing component which meets the requirements of 42 CFR Part 84,
subpart L, Table 11. Cartridges may incorporate particulate filters. Cartridges cannot be used in
immediately dangerous to life or health environments and are usually part of 84A or 23C approval
schedules.
Chest and Back Mounted - Canisters fastened to a user’s body, either on the back or chest, that have a
breathing tube running from the canister to the facepiece inlet.
Chin Mounted - A canister, cartridge, or filter mounted on the full facepiece. Chin-style gas masks
typically have a medium-sized (250-500 cm
3
) canister rigidly attached to a full facepiece.
Combination Particulate Filtering and Gas/Vapor Removing - Cartridges and canisters that protect the
user from both particulates and gases and vapors.
Common Assembly Matrix - An assembly matrix (diagram) that contains all of the information for a
series of applications. A common assembly matrix should be found in the last application of the series.
Also, a suggested processing order and an explanation as to how the applications interrelate must be in
the Approval History, if applicable. In addition, assembly matrices should not contain information for
future submissions. (See “Series of Applications”).
Component - Essential parts to a respirator that provide function and effective performance of the
product. (See “Major Subassemblies”).
Controlled Document - Documents signed, released, and placed in an applicant’s document control
system.
Correlation Testing - Testing conducted to compare an applicant’s test equipment and results to
NIOSH’s. The applicant must submit a new application with the wording “Correlation testing only;
respirator is not submitted for approval” in the “Reason for Application” section.
Critical Characteristic - A feature that, if not manufactured properly, could have an adverse impact on
the safety or health of the user. 100% testing or inspection is required prior to shipment to ensure
conformance with all technical requirements of the approval.
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As defined in 42 CFR Part 84: “Critical” A defect that judgement and experience indicate is likely to
result in a condition immediately hazardous to life or health for individuals using or depending upon
the respirator.
Critical User Instructions - Instructions that are important to operate a particular respirator. For
instance, checking the service life indicator on a CCER is a critical user instruction.
Delist - Respirator listing is removed from the Certified Equipment List when NIOSH approval is
rescinded or revoked.
Design - The overall specification for the respirator that includes materials, physical envelope and
shape, manufacturing processes, and Quality Assurance requirements.
Discontinued - See obsolete.
Exploded-View Drawing - A drawing of the complete respirator assembly showing all major
subassemblies and accessories and their proximity to one another.
Family of Products - A group or series of respirators sharing a common major subassembly, such as a
facepiece or regulator. The applicant determines the basis for the respirator families.
Facepiece - A respirator component designed to provide a gas-tight or dust-tight fit with the face and
may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas
source.
Facepiece Mounted - A canister, cartridge, or filter mounted on the facepiece.
Features - Descriptors that relate to the makeup, shape, proportions, outward appearance, prominent
characteristics, or qualities of the part, but are not separate components or devices. Do not list
features on the approval label (e.g., “super-soft face seal”).
Filter - A particulate removing component of a respirator which meets the requirements of
42 CFR Part 84, subparts K or KK.
Field-Replaceable - Any component, major subassembly, or accessory (e.g., cartridges, hoses,
regulators) that can be replaced by the user following the manufacturer’s User Instructions without
any special knowledge, skills, abilities, or equipment.
Filtering Facepiece - An N, R, or P class particulate respirator where the entire facepiece is composed
of the filtering media. The unit may have an exhalation valve, but has no replaceable parts.
Full Facepiece - A type of facepiece that covers a user from the hairline to below the chin.
Gas/Vapor Removing Respirator - A type of respirator that provides protection against specific gases
and vapors.
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Half-Mask - A type of facepiece that fits over the nose and under the chin and is used to protect users
Hardware - Regular production units submitted for approval must be the result of actual
manufacturing processes.
Hazardous Atmosphere - Any atmosphere that contains toxic or disease producing gas, vapor, dust,
fume, mist, or pesticide, that is either immediately or not immediately dangerous to life or health.
Also, any oxygen-deficient atmosphere.
Helmet - A rigid protective headgear incorporated into the design of a respirator that covers the user’s
head and possibly the user’s neck.
Helmet Mounted - A canister, cartridge, or filter mounted on the helmet.
Hood - A light, flexible device covering only the head and neck, or head, neck, and shoulders of a user.
Hood Mounted - A canister, cartridge, or filter mounted on the hood.
Immediately Dangerous to Life or Health - Conditions that pose an immediate threat to life or health
or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive
materials, which are likely to have adverse cumulative or delayed effects on health.
Inactive - See obsolete.
Intrinsically Safe - Not capable of releasing enough electrical or thermal energy under normal or
abnormal conditions to cause ignition of a flammable mixture such as methane or natural gas or air
comprised of an easily ignitable composition.
Major Subassemblies - Those components or subassemblies (1) that are essential to the respirator’s
function and effective performance; (2) that affect the respirator’s performance or design; and (3)
which are field-replaceable items.
Manufacturer’s Code - A unique three-letter code assigned to each approval holder by NIOSH.
Model Number - An identifier of a product given by the manufacturer. A model number is not
required to identify each unique configuration.
Mouthpiece - A respirator component that is held in the teeth with a clamp to close the nostrils that
provides a gas-tight or dust-tight fit with the mouth.
New Design - An entirely new or substantially modified respirator, component, or arrangement of
components (some of which may have been used on previously approved respirators) which NIOSH has
not evaluated in this configuration.
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Not Immediately Dangerous to Life or Health - Any hazardous atmosphere which may produce
physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse
physiological symptoms after prolonged exposure.
Nuisance Level Contaminants - Contaminants where the concentration in the atmosphere is below the
established PEL (OSHA permissible exposure limit) or REL (NIOSH recommended exposure limit),
whichever is lower. Nuisance level protection capability is not evaluated by NIOSH.
Obsolete - A respirator is considered obsolete when it is no longer manufactured or supported by the
approval holder. However the NIOSH approval is still listed and the respirators can still be used until
the units can no longer be maintained in an approved configuration. Approval remains active and is
shown in the CEL as obsolete.
Part Number - The unique number referenced by users to identify respirator parts. The identifying
number located on the component must match the part number shown on all labels (abbreviated and
full) and on the assembly matrix. The location of the part number on the component hardware must
be shown on the drawings. Applicants sometimes refer to the part number as catalog number,
manufacturer number, production component number, among other terms.
Particulate Filtering Respirator - A type of respirator that protects users against solid particles or
liquids such as dusts, fumes, and mists by trapping the particles with its fibers. The filters are classified
by NIOSH as N, R, or P accompanied by either 95 (95%), 99 (99%), or 100 (99.97%) to indicate filtration
levels.
Permissible Exposure Limit (PEL) - An OSHA permissible exposure concentration limit based on health
data evaluation. Users working in contaminate levels below this concentration are not required by
OSHA to have respiratory protection.
Pre-filter - An accessory item situated in front of the approved filter that removes coarse particles but
does not meet 42 CFR Part 84 criteria for particulate filters. A pre-filter is a filter often used prior to an
N-, R-, or P-series filter or cartridge. Pre-filters are not classified as N-, -R, or P-series filters. When pre-
filters are used, the complete assembly must meet the resistance requirements of 42 CFR Part 84. Pre-
filters may be listed on the approval labels. If shown on the approval label, pre-filters must be listed as
an accessory and designated as a pre-filter.
Pre-Submission Test Data - Respiratory performance test data must accompany each application and
must specify components used for test configuration by part number, show units of measure for all
test data (matching 42 CFR Part 84 criteria), and submit copies of actual test data with all results and
conclusions.
Performance - The actual operational performance of the respirator with respect to the applicable
regulations and design parameters. The respirator must meet or exceed the requirements of the
NIOSH regulations under 42 CFR Part 84 when evaluated against NIOSH standard test procedures
(STPs) as appropriate to the type of respirator.
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Primary Contact - The person designated by the prospective approval holder to receive all official
NIOSH correspondence, including but not limited to approval and denial letters, manufacturers
meeting notices, and notices seeking input for standards development. If this person changes, it is the
responsibility of the manufacturer to notify NIOSH, in writing, of the person taking over this
responsibility. The preference is for the Primary or Alternate Contact to make the notification to
NIOSH prior to the change. Alternatively, a corporate officer may notify NIOSH.
Private Label - A respirator labeled as belonging to an organization that is not the approval holder.
Private-labeled respirators are assigned the same TC number issued to the approval holder for the
original product. Only the approval holder can apply for a private label.
Private Packaging - A respirator that is repackaged and sold by a company that is not the approval
holder. All part numbers, model numbers, and approval labels must be the same as those approved by
NIOSH. However, the packaging may reference the packaging company instead of the approval holder.
The approval holder is responsible for ensuring that private packaging arrangements do not mislead
the end user.
Product Quality Control Plan (PQP) - Summarizes the manufacturing, inspection, test operations, and
applicable documents used in regular production of a specific respirator family.
Product Trade Name - A name that uniquely identifies a respirator or respirator family. A product
trade name is required because of the way approval holders market and users reference certified
respirators. The product trade name must not imply use for a specific hazard.
Protection - A different type of protection is defined as protection against a different atmospheric
contaminant (e.g., particulates, chlorine gas, ammonia gas, mercury vapor, etc.). A different level of
protection is defined by a change in the type of facepiece (half-mask, full facepiece) or mouthpiece,
filtering efficiency (such as N95 as opposed to N100), and/or the air supply capability (e.g., pressure,
duration, demand flow, continuous flow, etc.).
Prototype - Defined as a respirator or component that (a) involves a new design produced using rapid
prototyping methods, temporary tooling, non-production tooling, or regular production tooling in a
new fashion, and (b) has demonstrated by the applicant’s pre-testing to meet 42 CFR Part 84 minimum
design and performance requirements. Respirators may not be submitted for approval while in this
defined prototype stage (limited production tooling and processes). NIOSH will request samples made
on regular production tooling and production quality control (Ref. 84.30 (c)) if the approval holder
request approval. For non-approval prototype testing use a new application form and state “Prototype
Testing Only - Respirator is Not Submitted for Approval” in the “Reason for Application.”
Quality Assurance (QA) - A planned and systemic pattern of all activities necessary to provide
confidence that all respirators will perform satisfactorily in operation.
Quality Assurance (QA) Manual - Documents the approval holder’s quality systems including the
organizational structure, responsibilities, procedures, processes, and resources for implementing
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quality management and policy. Hard copies with original approval signatures need submitted and will
be retained in NIOSH’s files.
Quarter-Mask - A type of facepiece that covers the mouth and nose where the lower sealing surface
rests between the mouth and chin. Quarter-masks are most commonly found on dust and mist
respirators.
Recommended Exposure Limit (REL) - A NIOSH recommended exposure concentration limit based on
health data evaluation. Users working in contaminate levels below this concentration are not required
by OSHA to have respiratory protection.
Regular Production Unit - A respirator or component made on regular production tooling, or that is
identical to units made using regular production tooling, and is not made with any operations that will
not be included in regular production.
Rescission - The approval holder voluntarily requests the certificate of approval be withdrawn for a
product. The approval is no longer valid. Respirators in the field are no longer NIOSH-Approved.
Respirators are not listed in the CEL.
Respirator - Any device designed to provide the wearer with respiratory protection against inhalation
of a hazardous atmosphere.
Resubmission of an Application - Resubmission of a previously denied application. Resubmitted
applications receive a new task number (TN) and are placed at the end of the application processing
queue. All documentation must be updated to the current dates and revision levels.
Revocation - NIOSH reserves the right to revoke, for cause, any certificate of approval issued pursuant
to the provisions of 42 CFR Part 84. Such causes include, but are not limited to, misuse of approval
labels and markings, misleading advertising, and failure to maintain or cause to be maintained the
quality control requirements of the certificate of approval. The approval is no longer valid. Respirators
in the field are no longer NIOSH-Approved. Respirators are not listed in the CEL.
SEI Retrofit - An update or correction to a suspected performance or design issue to a Self-Contained
Breathing Apparatus (SCBA) that is approved by NIOSH and the Safety Equipment Institute. This type
of SCBA is approved jointly by NIOSH and SEI for use in firefighting operations.
Series of Applications - A series of associated applications submitted at the same time (in the same
bundle or package). A common assembly matrix that contains all of the information for the submitted
series is located in the last application of the series. Assembly matrices must not contain information
regarding future submissions.
Service Life Plan - A document that contains information on the reliability engineering methodology
and appropriate service life dates that users may rely on for determining safe and reliable performance
of the respirator under intended use conditions.
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Simplified Drawings - Exploded-view and major subassembly drawings that accompany the
application. Any additional drawings necessary for clarification of a major subassembly or part may
also be included.
Standard Application Form (SAF) - The electronic form used to submit respirator approval requests to
NIOSH.
Subcontractor - The entity contracted to produce products under the direction/oversite of the
prospective approval holder.
Supplier - The entity that produces components or subassemblies under their own quality system for
delivery to the approval holder.
User Instructions - Detailed instructions provided to the user that describes how to properly inspect,
don, and use the product.
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ACRONYMS
AAR# - Applicant Assigned Reference Number
ABMS - Automated Breathing Metabolic Simulator
AP - Air-Purifying
APRS - Air-Purifying Respirator Section
AQL - Acceptable Quality Level
AS - Air-Supplied
ASR - Air-Supplied Respirator (See SAR)
BMS - Breathing Metabolic Simulator
CAR - Corrective Action Request
CBRN - Chemical, Biological, Radiological, and Nuclear
CCER - Closed-Circuit Escape Respirator
CEL - Certified Equipment List
CFR - Code of Federal Regulations
CGA - Compressed Gas Association
CV&SDB - Conformity Verification and Standards Development Branch
EBSS - Emergency Breathing Support System
EIN - Employer Identification Number
ESLI - End-of-Service-Life Indicator
EOSTI - End-of-Service-Time Indicator
ETB - Evaluation and Testing Branch
HHS - Department of Health and Human Services
HSBG - Human Subject Breathing Gas
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IDLH - Immediately Dangerous to Life or Health
LRPL - Laboratory Respirator Protection Level
MSHA - Mine Safety and Health Administration (Department of Labor)
NFPA - National Fire Protection Association
NIOSH - National Institute for Occupational Safety and Health
NPPTL - National Personal Protective Technology Laboratory
OSHA - Occupational Safety and Health Administration (Department of Labor)
PAPR - Powered Air-Purifying Respirator
PEL - Permissible Exposure Limit (OSHA)
PQP - Product Quality Control Plan
QA - Quality Assurance
REL - Recommended Exposure Limit (NIOSH)
RPD - Respiratory Protective Devices
RPU - Regular Production Unit
SAF - Standard Application Form
SAP - Standard Application Procedure
SAR - Supplied-Air Respirator
SCBA - Self-Contained Breathing Apparatus
SCP - Standard Conditioning Procedure
SCSR - Self-Contained Self-Rescuer
SEI - Safety Equipment Institute
SOP - Standard Operating Procedure
STP - Standard Test Procedure
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TC Number - Testing and Certification Number; the NIOSH approval number designation
TN - Task Number; a unique number assigned by NIOSH to each application
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Revision History
Date
Section
Action
8-Jan-18
Section 1
1.1.9 Submitting
Test Samples
First paragraph, third sentence. Changed: cylinder pressure to
pressure reducers,
Added second paragraph: All sample components must be
identified and labeled with the corresponding part number as
listed on the assembly matrix.
8-Jan-18
Section 1
1.2.2
Extensions of
Approval
Application
Added second paragraph under second drawing: This includes
any minor changes to any document that is part of the approval
record. These changes should be submitted for an extension of
approval at your earliest convenience. NOTE: documents not up-
to-date in the NIOSH record could be identified during a site
audit and result in a non-conformance.
8-Jan-18
Section 1
1.2.3
Quality Assurance
Approval
Application
First bullet Changed from: Used for new or updated Quality
Assurance (QA) Manuals only.
To Current NIOSH approval holders may use this type of
application to submit new or updated Quality Assurance (QA)
Manuals. This type of application is limited to current approval
holders.
8-Jan-18
Section 2
9 (Section C.9)
Reason for
Application
Third paragraph. Added: Also list the Corrective Action Request
(CAR) number associated with the application.
8-Jan-18
Section 2
11 (Section C.11)
Description of
Respirator
After the 11th entry - If the respirator contains electrical
components … Added: NOTE: If the respirator is to be used
in underground mines or for mine rescue and has
electronics, MSHA intrinsic safety approval must be
received prior to submitting to NIOSH.
8-Jan-18
Section 2
12 (Section C.12)
Intended Protection
and Safety Design
End of second paragraph. Added: In addition, if the respirator
has electronic components, MSHA intrinsic safety approval must
be received prior to submitting to NIOSH.
8-Jan-18
Section 2
13 (Section C.13)
Pre-Submission
Performance Test
Data and
Statements
Second paragraph. First line. Deleted: ESLI
8-Jan-18
Section 2
15 (Section C.15)
Test Samples
Third paragraph, second sentence. Added: as it is listed on the
assembly matrix
8/
4/2022 SCBA and CBRN SCBA
103
8-Jan-18
Section 3
3.1 Quality
Assurance
Documentation
Second paragraph. Third sentence. Added: in a separate QA
Application,
8-Jan-18
Section 3
3.5 Combination
Supplied-Air
Respirators and
SCBA …
Paragraph under Test Fees to be Charged for New and
Unspecified Tests: Deleted: Do not issue a single payment
(check or pay.gov) for multiple invoices. Separate payments
(check or pay.gov) are required for each application invoice
received. Include the AAR# on the payment so it is properly
credited.
Added: A single payment (check or pay.gov) for multiple
invoices is allowed. Include the AAR#s for each associated
application on the check or the pay.gov receipt so they will be
properly credited. Separate payments (check or pay.gov) will
also be allowed for each application invoice. For application fee
invoices, include the TN number(s) associated with the
payment. To indicate a final payment for a specific
application(s), add an -F after the TN number(s) (TN-nnnn-F).
8-Jan-18
Section 3
3.6
Annual (Fixed) Fees
…
Deleted: Only one application per check.
8-Jan-18
Section 3
3.8
Drawings for SCBA
…
Fourth sentence Deleted: However, it is suggested that
applicants also use their three character manufacturer’s code in
drawing filenames (XXXnnnnRa.dwg).
8-Jan-18
Section 3
3.12
List of NIOSH
Cautions …
E
nd of cautions and limitations. Added: If the respirator
contains electrical components and the applicant wishes to list
the respirator on the NIOSH approval label as intrinsically safe,
intrinsic safety approval must be received from MSHA under Title
30 CFR Part 18 or a recognized independent laboratory.
Verification of such approval must be submitted with the
application. If the respirator is for underground use, MSHA
intrinsic safety approval must be received prior to submitting to
NIOSH.
8-Jan-18
Section 3
3.13
Private Labeling …
Third paragraph Added: A specific section titled "S-Special ...
8-Jan-18
Section 3
3.14
User Instructions
Second sentence. Added words. Sentence now reads. User
Instructions must be listed on the assembly matrix for Self-
Contained Breathing Apparatus, and are required.
8/
4/2022 SCBA and CBRN SCBA
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8-Jan-18
Section 3
3.14
User Instructions
Sixth paragraph. Added: under a Special "S" titled listing:
12-Mar-18
Section 3
3.16
Summary of
Related Documents
Added at the end: In addition to the application file, the
manufacturer must submit related project documents. These
documents must be in English and saved with the following file-
naming conventions. Any files created in a language other than
English will be returned unprocessed.
8-Jan-18
Section 3
3.17
File Naming
Conventions
Added an additional bullet: NIOSH will only accept single
documents under a single filename. Multiple documents under a
single filename will not be accepted and the application may be
denied.
8-Ja
n-18
Section 4
4.4
Denial of a Project
Undergoing NIOSH
Evaluation
8th bullet. Deleted: a filter media and alternate. Added: a
SCBA unit for entry and escape and an alternate unit for escape
only. Now reads: The official submittal either (1) requested
approval of two respirators of different basic designs (includes
submitting a SCBA unit for entry and escape and an alternate
unit for escape only in the same application)
8-Jan-18
Section 4
4.4
Denial of a Project
Undergoing NIOSH
Evaluation
11th bullet: added with MSHA intrinsic safety. Now reads:
Protection or intended use claims have not been requested or
approval has not been obtained from other governing agencies
(such as MSHA for mine use with MSHA intrinsic safety or
intrinsic safety from recognized laboratories).
8-Aug-22
Section 5
Test Selection
Guide for Self-
Contained
Breathing
Apparatus and
CBRN Self-
Contained
Breathing
Apparatus
Updated: Correct links to STPs
8-Jan-18
Section 6
6.1 NIOSH
Respirator
Application
Checklist
Test Samples
Added to item 9 : as listed on the assembly matrix.
8-Jan-18
Section 6
6.1 Private Label
Checklist …
Item 28. Changed to: The harness labels, primary company,
and private label company, if applicable, are listed and shown on
page two of the applicable drawings.
8-Jan-18
Section 6
6.2 Exploded-view
Drawing Checklist …
Item 1: Added: (as required).
8/
4/2022 SCBA and CBRN SCBA
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8-Jan-18
Section 6
6.5
Respiratory Inlet
Covering
I
tem 1. Second sentence. Changed from: Does not apply to
types B, BE, C, and CE.
To: Does not apply to types A, AE, B, and BE.
8-Jan-18
Section 6
6.6 Private Label
Checklist …
Item 5A. Added: /Harness
Item 5A.c. Added numbers(s)
8-Jan-18
Section 6
6.7 Assembly
Matrix …
Item 7: Deleted Nuisance OV.
Added: Quick Attachment cylinder.
8-Jan-18
Section 8
Label Format
Guidance
Bullet 12 Added second sentence: Protections are to include
the End-of-Service-Time Indicator version (EOSTI-25 or EOSTI-
33).
8-Jan-18
Appendix
Acronyms
Added: CAR - Corrective Action Request
