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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

Supplied-Air Respirators, Industrial Self-Contained 

Breathing Apparatus, and 

Combination Supplied-Air Respirators/Industrial SelfContained Breathing Apparatus

Under 42 CFR Part 84

Revised: August 4, 2022
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Table of Contents

Introduction ..................................................................................................................................................................4

Section 1 General Information for Supplied-Air Respirators and Combination SAR/SCBA.................................. 5

1.1 Getting Started...................................................................................................................................... 5

1.1.1 Who May Apply ........................................................................................................................... 5

1.1.2 Approval ...................................................................................................................................... 5

1.1.3 Applicants Without a Three Character Manufacturer’s Code ....................................................... 5

1.1.4 Applicants Without NIOSH Approval............................................................................................ 5

1.1.5 Where to Find the Standard Application Form............................................................................. 6

1.1.6 Submitting the Application .......................................................................................................... 6

1.1.7 Documents to Submit with the Application ................................................................................. 6

1.1.8 Submitting the Application and Associated Documents................................................................ 6

1.1.9 Submitting Test Samples (Hardware)........................................................................................... 6

1.2 Types of Applications............................................................................................................................. 7

1.2.1 New Approval Application............................................................................................................ 7

1.2.2 Extension of Approval Application............................................................................................... 8

1.2.3 Quality Assurance Approval Application.................................................................................... 11

1.2.4 Resubmission Application.......................................................................................................... 11

1.2.5 Amended Application ................................................................................................................ 12

1.2.6 Correlation Testing Only Application ......................................................................................... 12

1.3 Approval Label Protections and Cautions and Limitations for SARs and Combination SAR/SCBA ........ 13

Section 2 Specific Instructions for Preparing a SAR and Combination SAR/SCBA Application........................... 14

Section 3 Supplemental Information for Preparing an Application................................................................... 23

3.1 Quality Assurance Documentation ...................................................................................................... 23

3.2 Quality Assurance Manual................................................................................................................... 23

3.3 Product Quality Control Plan and Documentation............................................................................... 24

3.4 Fees..................................................................................................................................................... 25

3.5 Supplied-Air Respirator and Combination SAR/SCBA Test Fees........................................................... 26

3.6 Annual (Fixed) Certification Fees......................................................................................................... 27

3.7 Pay.Gov Instructions............................................................................................................................ 29

3.8 Drawings for a Supplied-Air Respirator and a Combination SAR/SCBA ............................................... 31

3.8.1 Exploded-View and Major Subassembly Drawing for a SAR and a Combination SAR/SCBA ..... 31

3.8.2 Example of an Exploded-View Drawing for a SAR and Combination SAR/SCBA ......................... 31

3.8.3 Major Subassembly Drawings for a SAR..........................................................................................32

3.8.4 Material Specifications on Drawings for a SAR and Combination SAR/SCBA.............................. 32
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3.9 Component Vendors............................................................................................................................ 32

3.10 Assembly Matrix................................................................................................................................ 32

3.11 Approval Labels and Private Labels.................................................................................................... 34

3.12 List of NIOSH Cautions and Limitations for a SAR and a Combination SAR/SCBA............................... 34

3.13 Private Labeling Versus Private Packaging ........................................................................................ 35

3.14 User Instructions ............................................................................................................................... 36

3.15 Packaging Art Work and Carton Design ............................................................................................. 37

3.16 Summary of Related Documents ....................................................................................................... 38

3.17 File Naming Conventions................................................................................................................... 39

Section 4 Approvals and Denials ...................................................................................................................... 41

4.1 Approval Documentation .................................................................................................................... 41

4.2 Denial Documentation......................................................................................................................... 41

4.3 Denial Prior to Assignment of a Task Number...................................................................................... 41

4.4 Denial of a Project Undergoing NIOSH Evaluation ............................................................................... 42

4.5 Respirator Certification (Approval) Program Decision Review Process................................................ 42

Section 5 Supplied-Air Respirator Test Selection Guide.................................................................................... 43

Section 6 Supplied-Air Respirator and Combination SAR/SCBA Checklists ....................................................... 52

6.1 NIOSH Respirator Application Checklist............................................................................................... 52

6.2 Exploded-View Drawing Checklist for a Supplied-Air and Combination Supplied-Air/SCBA................. 54

6.3 All Major Subassemblies Checklist for a Supplied-Air Respirator and Combination SAR/SCBA ............ 55

6.4 Supplied-Air Respirator ....................................................................................................................... 56

6.5 Self-Contained Breathing Apparatus.................................................................................................... 57

6.6 Self-Contained Breathing Apparatus.................................................................................................... 58

6.7 Private Label Checklist for a Supplied-Air Respirator and Combination SAR/SCBA Checklist ............... 59

6.8 Document Examples for Supplied-Air Respirators and Combination SAR/SCBA................................... 60

Section 7 - Documents Examples for a Supplied-Air Respirator ........................................................................... 61

7.1 Example Supplied-Air Respirator Product Quality Plan........................................................................ 61

7.2 Example Product Quality Plan for Self-Contained Breathing Apparatus Respirators............................ 62

7.3 Example of an Exploded-View Drawing for a Supplied-Air Respirator................................................ 623

7.4 Example of an Exploded-View Drawing for a Full Facepiece Combination SAR/SCBA .......................... 64

7.5 Example Assembly Matrix Combination SAR and SCBA Respirators..................................................... 65

7.6 Example of an Approval Label for a Supplied-Air Respirator with Egress SCBA.................................... 66

7.7 Example of an Approval Label for a Supplied-Air Respirator................................................................ 67

Section 8 - Label Format Guidance....................................................................................................................... 68

Appendix ............................................................................................................................................................. 69

Definitions........................................................................................................................................................... 80

Acronyms ............................................................................................................................................................ 88
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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 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 Supplied-Air Respirators (SAR), Industrial Self-Contained Breathing 

Apparatus (SCBA), and Combination Supplied-Air Respirator and Industrial Self-Contained Breathing 

Apparatus (SAR/SCBA). Please see the appropriate application for the respirator being submitted.

Schedule 13F

• Self-Contained Breathing Apparatus for Entry or Escape, Demand or Pressure-Demand, OpenCircuit or Closed-Circuit;

• Combination Supplied-Air Respirator and Escape Only Self-Contained Breathing Apparatus;

and

• Combination Supplied-Air Respirator and Self-Contained Breathing Apparatus.

Schedule 19C 

• Supplied-Air Respirators.

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 for Entry or Escape, Demand or PressureDemand, Open-Circuit or Closed-Circuit, Combination Supplied-Air Respirator and Escape-Only SelfContained Breathing Apparatus, Combination Supplied-Air Respirator and Self-Contained Breathing 

Apparatus, or Supplied-Air Respirator. The paragraphs are numbered to correspond with the sections 

of version 8 of the standard application form (SAF). 

Additional guidance and information related to SARs is included in the sections that follow and should 

be used as reference.
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Section 1 General Information for Supplied-Air Respirators and 

 Combination Supplied-Air Respirators-Self-Contained 

 Breathing Apparatus

Instructions Specific for Preparing an Application for a Supplied-Air Respirator (19C 

and 13F Approvals). 

This guide applies strictly to Supplied-Air Respirators and Combination Supplied-Air 

Respirators and Self-Contained Breathing Apparatus. Please see the appropriate 

application and instructions for submitting an application for a different class of 

respirator.

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 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 

visit. 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 is only performed for new applicants (those without a NIOSH approval). Approval 

holders with joint NIOSH and Mine and Safety 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. 

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 SAR and Combination SAR/SCBA respirators 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

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 for

which it is to be used. For example, a facepiece that is to be used on three projects must have all three 
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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, and Correlation Testing Only 

Application, Resubmission of New Approval Application, and Resubmission of an 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 Extensions of 

Approval Applications identify the data fields that are being 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.

1.2.1 New Approval Application

• Used for new design, substantially different design, or different type or level of protection 

requested for an existing NIOSH-Approved respirator. 

• 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 If an applicant submits a new respirator with two new facepieces, for example, a halfmask and full facepiece that use the same air-supply assembly, NIOSH requires two 

separate applications resulting in two new approvals because each facepiece represents 

a separate design and level of protection.

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). 
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• Quality Assurance Manual (Manual to be submitted separately as a 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 Extension 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. 

• All TC numbers affected must be listed in the “Reason for Application.” 

• 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. 

• A product is made obsolete. 

• The approval holder wants to add multiple accessories to one previously approved respirator.

Additional Component Previously Approved SAR

• An approval holder requests the addition of an accessory to multiple previously approved 

respirators. 

The approval holder, 

company ABC, requests the 

addition of multiple 

accessories to their 

previously approved SAR 

described in TC-19C-xxxx

Voice Communication Unit

Regulator Docking Bracket

Spectacle Kit
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Additional Component Previously Approved SARs

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 a typographical error in a drawing. 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 result in a non-conformance.

If the type or level of protection changes, a New Approval Application must be submitted. For 

example, a Supplied-Air Respirator with a flow regulator may be submitted and approved. A 

subsequent submission of the same mask with a different flow regulator 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 full 

facepiece 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. 

The approval holder, company 

ABC, requests a single 

accessory to be added to 

multiple previously approved 

SARs.

TC-19C-1234

TC-19C-2345

TC-19C-1357
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• 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 airline hose to be used as an alternate to our ‘abc’ hose on our 

half-mask Supplied-Air Respirators, models 123, 456, and 789. No other components are affected. 

This request is for use of an alternate airline hose only." The Extension of Approval Application must 

clearly indicate:

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 to allow an alternate breathing tube, 

and the details are provided. 

This Extension of Approval Application is for our EZLine Supplied-Air Respirator family to allow 

an alternate breathing tube. This breathing tube, part number 12345, will be an alternate 

breathing tube for all approvals listed on the EZLine assembly matrix (EZLineAMrC.xls) which is 

included in our list of documents. The 12345 breathing tube utilizes a 45 degree elbow which 

allows greater mobility to the user than the original 67890 tube. The internal dimensions and 

the connectors are the same in both tubes. Test data is included to prove that the respirator 

performs the same regardless of which breathing tube is used. 

Specifies the change(s)

This request is for use of an alternate breathing tube only. No other components or processes 

are affected. Both breathing tubes are the same diameter and manufactured from the same 

materials. The performance of the respirator has not changed. 

States how the change(s) affect(s) the product

The current breathing tube design, 67890 has a 90 degree connector that, for some users, does 

not allow enough mobility. The new breathing tube has a 45 degree elbow connection that 

allows greater mobility for some users, but does not affect the respirator performance. 
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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.

When adding an accessory to a previously 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.

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 

• Current NIOSH approval holders may use this type of application to submit new or update 

Quality Assurance (QA) Manuals. This type of application is limited to current approval holders.

• No other actions will be accepted under this type of application. 

• QA Manual changes must include a revision history sheet showing the 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.

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 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 change(s) impact(s) any of these aspects of the 

covered respirator(s), then applicants must submit an Extension of Approval Application to address this 

(these) change(s). 

1.2.4 Resubmission Application

• 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’ or ‘Resubmittal of Extension’ as appropriate. The 

“Reason for Application” must include the changes made to address the respirator or documentation 

deficiencies, an explanation 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.
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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 presubmission 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 SARs and 

Combination SAR/SCBA

PROTECTIONS

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 for SARs

A Not for use in atmospheres containing less than 19.5 percent oxygen.

B Not for use in atmospheres immediately dangerous to life or health.

C Do not exceed maximum use concentrations established by regulatory standards.

D Airline 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’s 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.

K The Occupational Safety and Health Administration regulations require gas-proof goggles to be 

worn with this respirator when used against formaldehyde.

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.

CAUTIONS AND LIMITATIONS for SCBAs

A Not for use in atmospheres containing less than 19.5 percent oxygen.

J Failure to properly use and maintain this product could result in injury or death.

K The Occupational Safety and Health Administration regulations require gas-proof goggles to be 

worn with this respirator when used against formaldehyde.

L Follow the manufacturer's User Instructions for changing cartridges, canister and/or filters.

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.
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Section 2 Specific Instructions for Preparing a Supplied-Air 

 Respirator and Combination Supplied-Air Respirator/

 Self-Contained Breathing Apparatus Application 

The paragraphs in this section are numbered to correspond to the different sections on 

version 8 of 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 applications are only 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.

• 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.
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Resubmission of Extension of Approval Application

• Resubmission will only be 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 Standard Test Procedures (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 submittal of the application.

• Explain what testing is required and indicate 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.

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.
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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 dropdown calendar. The NIOSH date of application is when the application 

is assigned a TN by NIOSH.

7 Type of Product (Section C.7)

Select Supplied-Air Respirator since this application applies only to Supplied-Air 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.

Standard SCBAs under 42 CFR Part 84 must receive joint approval from MSHA and NIOSH if the 

unit is intended for mine use or mine rescue.

Do we need to note anything for joint approval?

Note: For firefighter SCBAs, joint approval with SEI is needed, therefore refer to the CBRN SCBA 

SAP for guidance.

Is this application dependent upon the approval of an application in process? 

If Yes, specify the applicable AAR# or TN.

If the same respirator is being added as a private label, the second application cannot be approved until 

the first application is approved.
8/4/2022 17 SAR SAP

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.

Resubmittal Application 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.

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 
8/4/2022 18 SAR SAP

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 Supplied-Air Respirator:

The new outer air supply tube material documented on revised specification sheet ASH-FL-A02 

Revision A.

The change is documented on the tube bill of materials (Item 2) on page 3 of drawing 104-01 

Revision D.

This modification does not affect facepiece fit, breathing resistance, airflow, nonkinkability, and

permeation. Happy Breathing Company has tested the respirator with this tube and finds that 

it still meets the requirements of 42 CFR Part 84 for breathing resistance, airflow, 

nonkinkability, and permeation. Happy Breathing Company has not changed any of the 

connectors, air supply control valves, or other respirator components since they were granted 

NIOSH approval in TN-xxxxx. Happy Breathing Company is relying on the breathing resistance, 

airflow, and other data accompanying this submission, AAR#ph24, to obtain this approval.

This change will be applicable to the XXX mask 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.

Note: SEI submissions are for SCBA respirators only. If submitting for SEI joint approval, please 

refer to the SCBA SAP.

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.

Select Type of CBRN, if applicable.

In this case, select SCBA if submitting for CBRN approval.
8/4/2022 19 SAR SAP

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, the unit requires 

approval from MSHA for its electrical components. 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 Supplied-Air Respirator Questions

Type of Supplied-Air Respirator – Choose from dropdown options: 

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.
8/4/2022 20 SAR SAP

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, minimum

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)

Supplied-Air Respirators only: 

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 their intended use (e.g., exposure 

to elevated concentrations of oxygen).

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 Section 75.1714. In 

addition, if the respirator has electronic 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. 
8/4/2022 21 SAR SAP

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 84 subparts H 

and 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 the applicant 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.

Note for resistance testing: 

Applicant data must include airflow for all combinations of related Supplied-Air Respirators (including

combination units). This data must be representative of each complete assembly (including facepiece)

seeking approval. For airflow testing, NIOSH will test and verify the highest and lowest airflow 

combinations reported by the applicant.

For non-NFPA SCBAs the requirement on end-of-service-time indicator (EOSTI) is a minimum of 25% of 

full capacity. See the CBRN SCBA SAP for NFPA compliance to EOSTI.

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 SAF 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 Part84 standards.

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 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 
8/4/2022 22 SAR SAP

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. Crossreferenced 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 hardware samples 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.

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. 
8/4/2022 23 SAR SAP

Section 3 Supplemental Information for Preparing an 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 (QA) 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 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. 

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. 
8/4/2022 24 SAR SAP

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 must be 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 Supplied-Air Respirator drawing. 

F. Assembly matrix. 
8/4/2022 25 SAR SAP

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 hardware samples) 

are received. If a domestic applicant utilizes Pay.Gov, 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 

production facility. 

• Prospective approval holders: 

 ▫ One day domestic site visit - $2,500.

 ▫ One day international site visit - $7,500.

Upon agreement on the date of 

the site qualification. 

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 
8/4/2022 26 SAR SAP

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 Supplied-Air Respirator and Combination Supplied-Air/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 combination SAR/SCBA respirators.

 

New Site Qualification Fee, Existing Manufacturer $400.00

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

0114 Sound Level Hood/Helmet Escape SCBA $450.00

0115 Rated Service Time, CF, Escape SCBA $150.00

0116 Airflow Resistance, CF, Escape SCBA with Hood $150.00

0117 Positive Pressure, PD, CCSCBA, $150.00

0118 Low Temperature Operation SCBA $1,200.00

0119 Low Temperature 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
8/4/2022 27 SAR SAP

0123 Gas Flow Measurement, SCBA, Demand and PD $150.00

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

0127 Bypass Valve Flow, CCSCBA, Demand and PD $150.00

0128 Accuracy of Gauge, SCBA $150.00

0132 Inhalation Breathing Resistance, Demand SCBA $150.00

0133 Exhalation Breathing Resistance, PD SCBA $150.00

0134 Gasoline Permeation of Breathing Bag, CCSCBA $750.00

0135 Inhalation and Exhalation Resistance, CCSCBA, D/PD $150.00

0136 Demand Gas Flow, CCSCBA, Demand and PD $150.00

0137 Continuous Gas Flow, CCSCBA, CF and Demand Flow $450.00

0138 Safety Relief Valve Operation, CCSCBA, Demand/PD $150.00

0139 CO2 Facepiece Level Determination, SCBA $450.00

0140 Man Tests, SCBA $3,000.00

0141 Man Test 5, CCSCBA $150.00

0142 Vibration (Ro-Tap), Man Test 1, CCSCBA, Demand Esc $750.00

0143 Low Temperature Operation, CCSCBA $1,200.00

0144 Gas Flow, Constant Flow CCSCBA $300.00

0145 Sound Level End-of-Service-Life Indicator, SCBA $750.00

0146 Diaphragm Over pressurization, Belt Mounted SCBA $300.00

0147 Mode Transfer Test, SCBA/SAR $150.00

0148 Remote Gauge Leak Flow, SCBA, Demand and PD $150.00

0148A Remote Gauge Leak Flow, CCSCBA, Demand and PD $150.00

0155 Man Test 6, SCBA Liquefied Gas $2,400.00

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 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: 
8/4/2022 28 SAR SAP

Respirator Certification 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 listed1 approval on file with 

NIOSH on July 1st 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 listed1 approval on file with 

NIOSH on July 1st of each applicable year. October 30 of applicable year. 

Maintenance of 

Test Equipment

42 CFR 

§84.20(b)(2)

$36 per every active3 approval on file with 

NIOSH on July 1st 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#, TN, or NIOSH invoice number. 

 
8/4/2022 29 SAR SAP

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.

3. For “Payment Options,” select the “NIOSH User Fee” from the three 

choices.
8/4/2022 30 SAR SAP

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. 
8/4/2022 31 SAR SAP

3.8 Drawings for a Supplied-Air Respirator and a Combination Supplied- 

 Air Respirator/Self-Contained Breathing Apparatus

All drawings must be in English. Drawings are accepted in Adobe Acrobat, 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 Supplied-Air 

 Respirator and a Combination Supplied-Air/Self-Contained Breathing 

 Apparatus

For Supplied-Air Respirators, 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 Supplied-Air Respirator 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 explodedview 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.

3.8.2 Example of an Exploded-View Drawing for a Supplied-Air Respirator and a 

 Combination Supplied-Air/Self-Contained Breathing Apparatus
8/4/2022 32 SAR SAP

3.8.3 Major Subassembly Drawings for a Supplied-Air Respirator

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. 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 Supplied-Air Respirator and a 

 Combination Supplied-Air Respirator/Self-Contained Breathing Apparatus

For material specifications, use the criteria of 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 formats 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 
8/4/2022 33 SAR SAP

example, for a Supplied-Air Respirator the schedule# is 19C, followed by the AAR# MOR699, the 

TC number cell for the first row of the new approval would be 19C-MOR699a. The second row 

would be numbered 19C-MOR699b, the third row would be numbered 19C-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.).

• The listing of User Instructions on Supplied-Air Respirator 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 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 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 or redesigned (N or R) components. If no cells are marked N or R, the 
8/4/2022 34 SAR SAP

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.

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 Supplied-Air Respirators. 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 all New Approval, and for Extensions 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 a Supplied-Air Respirator 

 and a Combination Supplied-Air Respirator/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

Special Cautions and Limitations. 

* 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.

K When used with half mask, gas proof goggles are required for formaldehyde. 

S With unique or unusual design or critical operation requirements or a private label 

version.

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.

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.
8/4/2022 35 SAR SAP

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, first 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 approval 

must be received first prior to submitting to NIOSH.

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 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 
8/4/2022 36 SAR SAP

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 Supplied-Air Respirators and Combination SuppliedAir Respirators and Self-Contained Breathing Apparatus. User Instructions must be listed and are 

required to be listed on the assembly matrix for Supplied-Air Respirators. 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 the paragraphs that were 

updated. A complete User Instructions document must be submitted. 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 an issue or a 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. 

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-19C-nnnn.” 
8/4/2022 37 SAR SAP

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 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 Supplied-Air Respirators and Combination SAR/SCBAs

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

Self-Contained Breathing 

Apparatus

Entire Harness assembly and canister (where applicable).

Supplied-Air Respirator Entire Respirator container or instruction card. Both for 

combination units.

When a company receives and accepts a NIOSH approval, they are agreeing to manufacture, inspect, 

and test the respirator as they stated in their 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 the plan change is reviewed and approved 

by NIOSH. 
8/4/2022 38 SAR SAP

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 Airline Paint Spray Respirator.” 

 A trade name implying use, such as “Airline Paintspray Plus Respirator.” 

Packaging may include a phrase such as: “NIOSH-Approved Airline respirator; recommended by the 

approval holder for lacquer paints.” 

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.

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.
8/4/2022 39 SAR SAP

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

Microsoft Word

nnnnQMa.PDF

nnnnQMb.TIF

nnnnQMc.XLS

nnnnQMd.XLSX

nnnnQMe.DOC

nnnnQMf.DOCX

Plus one signed paper copy

(a-f indicate various revision levels)

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

User Instructions (UI) 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 them in the assembly matrix 

by name.

• If NIOSH has requested replacement files, give the replacement files the same name as the 

original files.
8/4/2022 40 SAR SAP

• Send replacement files only at the request of NIOSH, and send them directly to the NIOSH 

employee requesting the files. The requestor is responsible for having the corrected files 

posted to your project.

• NIOSH will only accept replacement or new files that have been requested by NIOSH.

• NIOSH will only accept single documents under a single file name. Multiple documents under a 

single file name will not be accepted and the application may be denied.
8/4/2022 41 SAR SAP

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 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 sample hardware will be returned or destroyed. NIOSH will not 

retain documentation or sample hardware for any respirator that has failed to meet all of the 

requirements. If NIOSH denies an application based upon documentation issues, the application, CDRs 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, in an unacceptable file format, or 

uses an unacceptable file naming convention.

• Sample hardware, application package, and payment are not received within two weeks of one 

another.
8/4/2022 42 SAR SAP

• Shipping boxes contain sample hardware associated with different applications and without 

separate packaging to indicate what sample hardware goes with each application. 

• Packages of sample 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 supplied-air respirator with a regulator along with an alternate that is a 

regulator with a hot/cold tube in the same application) or (2) requested a new approval and an 

extension of approval 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 mining (along with MSHA intrinsic safety)). 

• QA documentation does not have sufficient inspections identified, 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 has a structured Decision Review Process that enables applicants to request a review of 

decisions regarding NPPTL policy statements, test procedures, and test results pertaining to ongoing 

respirator certification activities.
8/4/2022 43 SAR SAP

Section 5 Supplied-Air Respirator Test Selection Guide

Item Respirator Type *NIOSH Test # Title Total Materials Needed

7 SCBA - open-circuit, 

entry, demand

 Subpart H

TEB-APR-STP0004Determination of Exhalation 

Valve Leakage

2 complete units plus one 

each of all accessories

3 cylinder gauges,

3 remote gauges, as required

RCT-ASR-STP0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0124

Determination of Remaining 

Service Life Indicator - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP0126

Determination of Bypass 

Valve Flow - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP0140Man Tests - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0145

Determination of Sound Level 

Measurements for Remaining 

Service Life Indicators - SelfContained Breathing 

Apparatus
8/4/2022 44 SAR SAP

RCT-ASR-STP0146

Determination of Diaphragm 

Over Pressurization - Open 

Circuit, Self-Contained 

Breathing Apparatus with Belt 

Mounted Regulators and 

Breathing Tubes

RCT-ASR-STP0148

Determination of Remote 

Gauge Leak-Flow Test - OpenCircuit, Demand And 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0155

Man Test Number 6 - SelfContained 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, pressuredemand

RCT-ASR-STP0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

 2 complete units plus one 

each of all accessories

 3 cylinder gauges

 3 remote gauges, as required

RCT-ASR-STP0120

Determination of Positive 

Pressure - Open-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0124

Determination of Remaining 

Service Life Indicator - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP0126

Determination of Bypass 

Valve Flow - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus
8/4/2022 45 SAR SAP

RCT-ASR-STP0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP0140Man Tests - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0145

Determination of Sound Level 

Measurements for Remaining 

Service Life Indicators - SelfContained Breathing 

Apparatus

RCT-ASR-STP0146

Determination of Diaphragm 

Over Pressurization - Open 

Circuit, Self-Contained 

Breathing Apparatus with Belt 

Mounted Regulators and 

Breathing Tubes

RCT-ASR-STP0148

Determination of Remote 

Gauge Leak-Flow Test - OpenCircuit, Demand And 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0155

Man Test Number 6 - SelfContained 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-STP0117

Determination of Positive 

Pressure - Closed-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus

2 complete units, plus one 

each of all accessories

21 scrubbers or O2

generating canisters

or

 21 fully charged O2 cylinders

plus

 1 breathing bag

 1 relief valve override tool 

(if needed)

 3 cylinder gauges

 3 remote gauges (if needed)

RCT-ASR-STP0121A

Determination of Rated 

Service Time - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0124A

Determination of Alarm 

Pressure - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP0127

Determination of Bypass 

Valve Flow - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0134

Determination of Gasoline 

Permeation Test on Breathing 

Bags - Closed-Circuit, SelfContained Breathing 

Apparatus
8/4/2022 46 SAR SAP

RCT-ASR-STP-

0135

Determination of Inhalation 

and Exhalation Breathing 

Resistance - Closed-Circuit, 

Demand And Pressure-

Demand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-

0136

Determination of Demand 

Gas Flow - Closed-Circuit, 

Demand and Pressure-

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

RCT-ASR-STP-

0148A

Determination of Remote 

Gauge Leak-Flow Test - 

Closed-Circuit, Demand and 

Pressure-Demand, Self-

Contained Breathing 

Apparatus
8/4/2022 47 SAR SAP

RCT-ASR-STP0155

Man Test Number 6 - SelfContained 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-STP0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

2 complete units plus one 

each of all accessories

3 cylinder gauges

RCT-ASR-STP0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP0140Man 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

12 SCBA - open-circuit 

escape, pressuredemand

RCT-ASR-STP0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

 2 complete units plus one 

each of all accessories

 3 cylinder gauges

RCT-ASR-STP0120

Determination of Positive 

Pressure - Open-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus
8/4/2022 48 SAR SAP

RCT-ASR-STP0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP0140Man 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-STP0114

Determination of Sound-Level 

Measurement - Escape, OpenCircuit, Self-Contained 

Breathing Apparatus Using 

Hoods or Helmets

 3 complete units

RCT-ASR-STP0115 

Determination of Rated 

Service Time - Constant-Flow, 

Escape, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP0116 

Determination of Airflow 

Resistance - Continuous-Flow, 

Escape, Open-Circuit, SelfContained Breathing 

Apparatus With Hoods

RCT-ASR-STP0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP0125A

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Hoods or Helmets

RCT-ASR-STP0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus
8/4/2022 49 SAR SAP

RCT-ASR-STP0140Man 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-STP0004Determination 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 minimum 

hose lengths 

plus

All necessary quickdisconnects

2 additional 25 foot lengths of 

air-line hose

RCT-ASR-STP0100

Determination of Strength of 

Hoses and Couplings - Type C 

and CE Supplied-Air 

Respirators

RCT-ASR-STP0101

Determination of Tightness of 

Hoses and Couplings - Type C 

and CE, Supplied-Air 

Respirators

RCT-ASR-STP0102

Determination of 

Nonkinkability of Hoses - Type 

C and CE, Supplied-Air 

Respirators

RCT-ASR-STP0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP0104

Determination of AirRegulating Valve 100,000 

Cycles Performance - Demand 

and Pressure-Demand, Type C 

and CE, Supplied-Air 

Respirators

RCT-ASR-STP0105A

Determination of Airflow -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP0108

Determination of Inhalation 

Airflow Resistance - Demand, 

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP0109

Determination of Exhalation 

Airflow Resistance - Demand, 

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP0110

Determination of GasTightness Test - Isoamyl 

Acetate, (IAA) - Type C, and 

CE, Supplied-Air Respirators

NOTE: For abrasive blast, type CE, supplied-air 

respirators, perform all above tests plus

RCT-ASR-STP0112

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-STP0004Determination of Exhalation 

Valve Leakage

All combinations of the 

maximum length of hose 

made up from the minimum 

hose lengths plus

All necessary quickRCT-ASR-STP- disconnects

0100

Determination of Strength of 

Hoses and Couplings - Type C 

and CE Supplied-Air 

Respirators
8/4/2022 50 SAR SAP

RCT-ASR-STP0101

Determination of Tightness of 

Hoses and Couplings - Type C 

and CE, Supplied-Air 

Respirators

2 additional 25-foot lengths of 

airline hose

All combinations of the 

maximum length of hose 

made up from the minimum 

hose lengths 

plus

All necessary quickdisconnects

2 additional 25-foot lengths of 

airline hose

RCT-ASR-STP0102

Determination of 

Nonkinkability of Hoses - Type 

C and CE, Supplied-Air 

Respirators

RCT-ASR-STP0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP0104

Determination of AirRegulating Valve 100,000 

Cycles Performance - Demand 

and Pressure-Demand, Type C 

and CE, Supplied-Air 

Respirators

RCT-ASR-STP0105A

Determination of Airflow -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP0106

Determination of Inhalation 

Airflow Resistance - PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP0107

Determination of Exhalation 

Airflow Resistance - PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP0110

Determination of GasTightness Test - Isoamyl 

Acetate, (IAA) - Type C, and 

CE, Supplied-Air Respirators

NOTE: For abrasive blast, type CE, supplied-air 

respirators, perform all above tests

plus 

RCT-ASR-STP0112

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

16 SA Type C-CE,

 constant flow TEB-APR-STP0004

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 minimum 

RCT hose lengths plus -ASR-STP0100

Determination of Strength of 

Hoses and Couplings - Type C 

and CE Supplied-Air 

Respirators

RCT-ASR-STP0101

Determination of Tightness of 

Hoses and Couplings - Type C 

and CE, Supplied-Air 

Respirators

All necessary quickdisconnects

2 additional 25-foot lengths 

of airline hose

RCT-ASR-STP0102Determination of 

Nonkinkability of Hoses - Type 
8/4/2022 51 SAR SAP

C and CE, Supplied-Air 

Respirators

RCT-ASR-STP0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP0105

Determination of Airflow -

Continuous Flow, Type C and 

CE, Supplied-Air Respirators

RCT-ASR-STP0110

Determination of GasTightness Test - Isoamyl 

Acetate, (IAA) - Type C, and 

CE, Supplied-Air Respirators

RCT-ASR-STP0111

Determination of Air Velocity 

and Noise Levels - Sound 

Level, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP0113

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-STP0112

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-STP0119 

Determination of LowTemperature Operation - 

Minimum Temperature per 

Applicant, Combination, 

Open-Circuit, Self-Contained 

Breathing Apparatus and 

Type C, and CE, Supplied-Air 

Respirators

RCT-ASR-STP0147 

Determination of Mode 

Transfer Test - Combination, 

Open-Circuit, Self-Contained 

Breathing Apparatus and 

Supplied-Air Respirators 

(SCBA/SAR)

For Combination SAR/AP:

RCT-APR-STP0014

Determination of Leakage Of

Drinking Tube and 

Accessories for Respirator 

Facepieces

 * Actual tests selected may vary depending on 

design and intended use
8/4/2022 52 SAR SAP

Section 6 Supplied-Air Respirator and Combination Supplied-Air 

 Respirator/Self-Contained Breathing Apparatus

 Checklists

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 a New Approval, Resubmission of an Extension of 

Approval, or Amended Application).

4. _____ The NIOSH TN where 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) shipped under separate cover

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 as listed 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 

Approval, Extension of Approval, Quality Assurance Approval, Correlation Testing Only
8/4/2022 53 SAR SAP

Approval, Resubmission of a New Approval, Resubmission of an 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 Supplied-Air Respirator 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 abbreviated 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 

applicableassembly 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. 
8/4/2022 54 SAR SAP

6.2 Exploded-View Drawing Checklist for a Supplied-Air and Combination SuppliedAir/SCBA 

1. _____ Drawing contains all major subassemblies and accessories that appear on the 

assembly matrix (except the User Instructions).

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. 
8/4/2022 55 SAR SAP

6.3 All Major Subassemblies Checklist for a Supplied-Air and Combination 

Supplied-Air/SCBA 

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.
8/4/2022 56 SAR SAP

6.4 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 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 NIOSH would interpret to be a 

Schrader style/compatible coupler manufacturer by Foster). The specific model or part 

number must be identified; “or equivalent” cannot be used

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.
8/4/2022 57 SAR SAP

6.5 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 

their intended use (e.g., exposure to elevated concentrations of oxygen). 

Cylinder & 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. Requirement is 90 to 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 U.S. 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 identified are listed. 

Respiratory Inlet Covering (Facepiece)

1. _____ If a pressure-demand valve, 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 anti-fog is needed or not.

4. _____ Statement to indicate if and when nose cup assembly is needed.
8/4/2022 58 SAR SAP

6.6 Self-Contained Breathing Apparatus 

Backpack Harness Assembly

1. _____ Inspection procedures or classification of defects include a visual inspection of the 

buckles.

2. _____ Location of NIOSH harness label is indicated. 

Pneumatic Assembly

1. _____ For all compressed gas SCBA, a statement that it has an in-line 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. 

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 84.98).

6. _____ Statement as to how the remote pressure gauge is attached, i.e., loctite or torque.

7. _____ Parts list showing all parts and materials of the pneumatic assembly.

First Stage Regulator

1. _____ Intermediate Pressure Range is listed 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.
8/4/2022 59 SAR SAP

6.7 Private Label Checklist for a Supplied-Air Respirator and Combination 

Supplied-Air Respirator/Self-Contained Breathing Apparatus Checklist

1. _____ An assembly matrix showing private label version under current approval (TC) number is 

included.

2. _____ If private label SAR 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 Supplied-Air Respirator model/part number.

4. _____ The harness private label is included on page two of the applicable drawing.

A. _____ Harness label must include the following items:

a. Private label company name.

b. NIOSH printed in block letters.

c. Appropriate approval (TC) number.

d. Protection (SA, PD, DE, etc.).

e. Model or part number.

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 Supplied-Air Respirator has been manufactured 

by approval holder xxx for private label company yyyy under TC19C-nnnn.

E. _____ Contact information and a contact person must be identified either in the 

application or on a separate sheet.
8/4/2022 60 SAR SAP

6.8 Document Examples for Supplied-Air Respirators and Combination 

 Supplied-Air Respirators/Self-Contained Breathing Apparatus

This checklist corresponds to the Example Assembly Matrix in Section 7.5

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 hot/cold tube). 

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.
8/4/2022 61 SAR SAP

Section 7 - Documents Examples for a Supplied-Air Respirator

7.1 Example Supplied-Air Respirator Product Quality Plan

Double Wing Manufacturing, Pittsburgh, PA Product Quality Plan (PQP)

DWFP Air Line Respirator Revision A, Date: 7/21/2015

Item Description Inspection Class Location AQL Test 

Method

Recorded 

Results

1 Full Facepiece Assembly 

Correct

Major A Assembly 

Station

100% Visual Assembly 

Station

Facepiece 

Leak Test

Major A Assembly 

Station

100% TP-00LT

Valve Leak 

Test

Major B Assembly 

Station

2.5% TP-00VL

2 Breathing Tube Assembly 

Correct

Major A Assembly 

Station

100% Visual Assembly 

Station

Flow Test Minor Assembly 

Station

4% TP-00BT

3 Flow Controller Flow Test Major A Assembly 

Station

100% TP-00FC Assembly 

Station

4 Air-line Hose Assembly 

Correct

Major A Assembly 

Station

1% Visual Assembly 

Station

Leak Test Major B Assembly 

Station

2.5%, 

Destructive

TP-00LH

Pull Test Major B Assembly 

Station

2.5%, 

Destructive

TP-00PT

5 Belt Assembly 

Correct

Minor Assembly 

Station

4% Visual Assembly 

Station

6 Accessory, 

Spectacle Kit

Assembly 

Correct

Minor Incoming 

Inspection

4% Visual Incoming 

Inspection
8/4/2022 62 SAR SAP

7.2 Example Product Quality Plan for Self-Contained Breathing 

Apparatus Respirators
8/4/2022 63 SAR SAP

7.3 Example of an Exploded-View Drawing for a Supplied-Air Respirator

Item Description Part Number

1 Full Facepiece 123FP

2 Breathing Tube 234BT

3 Flow Controller 345FC

4 Supply Hose 456SH

5 Belt 567BT

6 Accessory, Spectacle Kit 678AS

X User Instructions UI001

Approved Double Wing Manufacturing, Pittsburgh, PA

Drawing: 

DWW 

7/25/2015

Part Number: Title: LWFP Airline Respirator, 

Exploded-View 

Release: 

DDW 

7/26/2015

Scale: 

NTS

Revision: 

0

Drawing Number DWM003

4

5

1

2

6

3
8/4/2022 64 SAR SAP

7.4 Example of an Exploded-View Drawing for a Full Facepiece Combination 

Supplied-Air and Self-Contained Breathing Apparatus

Item Part Number Description

1 1000 Facepiece

2 R333 Second Stage Regulator

3 IH333 Intermediate Hose

4 FR333 First Stage Regulator

5 C004 Cylinder

6 PG004 Gauge Unit

7 H99 Harness

8 AL001-XX Air-Line Hose

9 ALC002 Air-Line Connection

X UI003 User Instructions

 

Approved Double Wing Manufacturing, Pittsburgh, PA

Drawing: 

DWW 

8/25/2015

Part Number: 

Model FF100SA

Title: Supplied-Air/SCBA 

Combination

Release: 

DDW 

8/26/2015

Scale: 

NTS

Revision: 

0

Drawing Number DWM007

1 2

3

4

5

6

7

8

9
8/4/2022 65 SAR SAP

7.5 Example Assembly Matrix Combination SAR and SCBA Respirators

Double Wing Manufacturing

123 Manufacturer Lane

Pittsburgh, PA USA

Phone: 412-555-1212

(G) TN or AAR # of a previously approved or pending matrix: N/A

(H) N/A see exploded-view drawing for each respirator configuration

Exploded-view drawing number: LWM007

Date: August 1, 2015 

Revision: 0

Item 7 1 5 8 2 4 6 9 3 X Description Harness Facepiece Cylinder Alternate Hoses/Length Second Stage Regulator First Stage Regulator Gauge Unit Airline Connection Intermediate Hose User Instructions

a b

Revision 1 2 2 0 0 0 1 2 1 0

AAR#

(C)

NIOSH 

Approval 

Number

TC- 

(D)

Protection 

(E)

Drawing 

Number

DR

H99 

DR

FP10

DRC004 DR

AL 

001-

50 

DR 

AL

001-

100 

DR

R333 

DR 

FR 

333 

DR 

PG 

004 

DR 

ALC002 

DR 

IH 

333 

DN

002 

UI

LMW

003 

13FAARaPD/SA/ESC

5 minutes

Model/Part 

Number

H99 1000 C004 AL

001-

50

AL

001-

100

R

333 

FR

333 

PG

004 

ALC

002 

IH

333 

002

UI

NIOSH Task Number where 

component was last tested. 

If new, indicate as “”N”

N N N N N N N N N N N

(B) N 1000 N N N N N 1001 1001 1001 N

 

Key:

X = currently approved in 

 this configuration

N = New Component or 

 Configuration

“-“ = Obsolete

R = Redesign

P = Pending

A = Accessory
8/4/2022 66 SAR SAP

7.6 Example of an Approval Label for a Supplied-Air Respirator with Egress SCBA

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

T500 SAR

Type C and CE Continuous Flow Supplied-Air Respirator with 10 Minute Escape Cylinder

These respirators are approved only in the following configurations:

RESPIRATOR COMPONENTS

TC- Protection1 Harness Alternate Facepiece Cylinder Alternate Hoses/Length Alternate Regulator Cautions and 

Limitations2

CROWN 100

0

200

0

300

0

100

1

100

2 943-25 943-50 943-100 3021

302

2

13FAARaPD/SA/ESC 

5 minutes X X X X X X X X X X X ABCDEJLMNOS

1. PROTECTION

PD - Pressure-Demand

SA - Supplied-Air

ESC - Escape-Only

3. CAUTIONS AND LIMITATIONS

A Not for use in atmospheres containing less than 19.5 percent oxygen.

B Not for use in atmospheres immediately dangerous to life or health.

C Do not exceed maximum use concentrations established by regulatory standards.

D Airline respirators can be used only when the respirators are supplied with respirable air meeting the 

requirements of CGA G-7. Grade D or high quality.

E Use only the pressure ranges and hose lengths specified in the User’s Instructions.

J Failure to properly use and maintain this product could result in injury or death.

L Follow the manufacturer's User Instructions for changing cartridges, canister and/or filters.

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
8/4/2022 67 SAR SAP

7.7 Example of an Approval Label for a Supplied-Air Respirator

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

T500 SAR

 Type C and CE Continuous Flow Supplied-Air Respirator 

These respirators are approved only in the following configurations:

T200 T100 T28061 T26-1 T28-0 T20-25 T20-50 T16-4 T18-1 T24-0 T24-4

19CAARa SA/CF T5000 

SA

X X X X X X X X X X BCDEJMNOS

19CAARb SA/CF T5000 

SB

X X X X X X BCDEJMNOS

Hose 

50'

Breathing 

Tube

Visor

Inner 

Lenses

Outer 

Lenses Facepiece

Hood 

or 

Helmet

Flow 

Regulator 

and Belt

Cape Quick 

Disconnect

Hose 

25'

Cautions and 

Limitations2 TC- Protection1 Model

Respirator Components

1. PROTECTION

CF - Continuous Flow 

SA - Supplied-Air

 

2. CAUTIONS AND LIMITATIONS

B Not for use in atmospheres immediately dangerous to life or health.

C Do not exceed maximum use concentrations established by regulatory standards.

D Airline 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’s Instructions.

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 air quality requirements, special use instructions, etc.]
8/4/2022 68 SAR SAP

Section 8 - Label Format Guidance • Labels for Supplied-Air Respirators 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 submissions 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 subassemblies for a respirator configuration is listed on the 

approval label, the subassemblies 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 included in the footnote 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 psi 30 min SC.

• 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 separate 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. On abbreviated 

cartridge labels, escape must follow each gas and vapor listed. “Esc” is the only acceptable 

abbreviation for escape.
8/4/2022 69 SAR SAP

APPENDIX
8/4/2022 70 SAR SAP

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-STD414 [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-STD414, 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 

advantage that it can be applied to characteristics which do not involve a numerical measurement 
8/4/2022 71 SAR SAP

(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.

2 It is acceptable to use a smaller (more stringent) AQL value.

Defect Classification AQL1,2

Major A 1.0

Major B 2.5

Minor 4.0
8/4/2022 72 SAR SAP

2.3 Critical Characteristics. Characteristicsidentified 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 determinesthe 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 isin 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

inspection is not permitted by NIOSH for that procedure. Tightened inspection is not required for the

Squeglia C=0 procedure.

Procedure Minimum Inspection Level

Normal Destructive1

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
8/4/2022 73 SAR SAP

4.2 Recordsto 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; MILSTD-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

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
8/4/2022 74 SAR SAP

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 parametersinfluencing 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 fewersamples, 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

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.
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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 Arrowsin 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.

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 piecesfrom each sublot.

10. References

American National Standards Institute [2003a]. Sampling procedures and tablesfor inspection by

attributes. Milwaukee, WI: American Society for Quality, American National Standard ANSI/ASQ Z1.4-2003.
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American National Standards Institute [2003b]. Sampling procedures and tablesfor 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 tablesfor 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 tablesfor 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 vck6@cdc.gov

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.

Sincerely yours,

Heinz 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

LETTER TO ALL RESPIRATOR MANUFACTURERS

Subject: Clarification of Supplier and Subcontractor Relationships

Background

National 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.

Definitions

Approval Holder: The party ofrecord 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.

Supplier:

A supplier produces components orsubassemblies 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.

Subcontractor:

The approval 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 forthe approval holder.
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Page 2 -Letter to All Respirator Manufacturers

Subcontractor Relationship Responsibilities

The approval documentation on file atNIOSH must demonstrate that the following criteria have

been met forNIOSH recognition of a subcontractor.

- As with all otherNIOSH approvals, the approval holder maintains responsibility for all 

aspects ofthe approval: control over product drawings, material specifications, parts lists,

andmanufacturing processes; control overthe requirements forfinal inspection and

testing; and approval of any changesto 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 andmaintain active involvement and influence over

subcontractor quality systems. This can be demonstrated inmany different ways. One

example ofthisinvolvement 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 formaintaining active involvement and influence over

their subcontractor's quality system needs to be documented in aplan or procedure that 

suitsthe individual situation and manufacturing complexity ofthe secured goods. This

plan or procedure must be formally submitted toNIOSH.

- 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.

- Allsubmissionsrelated 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 overthe subcontractor's quality system. Thisinformation must

be specifically indicated and documented aspart of aQuality Assurance Application. As

with all Quality Manuals, a process must be established and followed for ongoing

resubmission ofthe Quality Manual and related quality system documents inthe event of

significant changes, and on aperiodic basis, per NIOSH requirements.

- All subcontractor relationships must belisted as an approval holder's manufacturing site, 

with a designated point of contact, on theNIOSH Standard Application Form (SAF) for

directshipment fromthe subcontractorto be acceptable undertheNIOSH Approval.
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Page3-LettertoAllRespiratorManufacturers

- 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.

Sincerely yours,

Heinz 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.
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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 

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 cm3) 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. 
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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. 

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. 
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Gas/Vapor Removing Respirator - A type of respirator that provides protection against specific gases 

and vapors.

Half-Mask - A type of facepiece that fits over the nose and under the chin and is used to protect users 

from toxic materials.

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. 
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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.

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 prefilters are used, the complete assembly must meet the resistance requirements of 42 CFR Part 84. Prefilters 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 
8/4/2022 85 SAR SAP

NIOSH regulations under 42 CFR Part 84 when evaluated against NIOSH standard test procedures 

(STPs) as appropriate to the type of respirator. 

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.
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Quality Assurance (QA) Manual - Documents the approval holder’s quality systems including the 

organizational structure, responsibilities, procedures, processes, and resources for implementing 

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.
8/4/2022 88 SAR SAP

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
8/4/2022 89 SAR SAP

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
8/4/2022 90 SAR SAP

TC Number - Testing and Certification Number; the NIOSH approval number designation

TN - Task Number; a unique number assigned by NIOSH to each application
8/4/2022 91 SAR SAP

Revision History 

Date Section Action

12/14/2017

12/14/2017

Section 1

1.19

Submitting 

Test Samples

Added a last sentence to the first paragraph in this section: All 

sample components must be identified and labeled with their 

corresponding part numbers as listed on the assembly matrix.

12/14/2017

Section 1

1.2.2

Extension of 

Approval 

Application

Added second paragraph below the second drawing: Any changes 

to NIOSH-approved records (documents) must be submitted to NIOSH. 

This includes any minor changes to any document that is part of the 

approval record. These changes should be submitted for an extenion 

of approval at your earliest convenience. NOTE: Documents that are 

not up-to-date in the NIOSH records could be identified during a site 

audit and result in a non-conformance.

12/14/2017

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 used this type of application 

to submit new or updated Quality Assurance (QA) Manuals. This type 

of application is limited to current approval holders.

12/14/2017

Section 2

9 (Section C.9)

Reason for 

Application

Third paragraph. Added: Also, list the Corrective Action Request 

(CAR) number associated with the application.

12/14/2017

Section 2

12 (Section 

C.12) 

Intended 

Protection and 

Safety Design. 

Added at the end of the last paragraph: NOTE: If this respirator is to 

be used in underground mines and has electronics, MSHA intrinsic 

safety approval must be received prior to submitting to NIOSH.

12/14/2017

Section 2

15 (Section 

C.15)

Test Samples

Third paragraph. Second sentence. 

Added: as it is listed on the assembly matrix,

Sentence now reads: 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.

12/14/2017

Section 3

3.1 

Quality 

Assurance 

Documentation

Second paragraph. Third sentence. Changed to read: In a separate 

application, submit only the sections that have been revised and an 

updated revision history sheet. 
8/4/2022 92 SAR SAP

12/14/2017

Section 3

3.5 

Supplied-Air 

Testing Fees

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, 

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).

12/14/2017

Section 3

3.6 

Annual 

Certification 

Fees Deleted last sentence in section: Only one application per check.

12/14/2017

Section 3

3.8

Drawings for 

SAR ...

Deleted sentence: However, it is suggested that applicants also use 

their three character manufacturer’s code in drawing filenames 

(XXXnnnnRa.dwg).

12/14/2017

Section 3

3.12

List of NIOSH 

Cautions ...

Special Cautions and Limitations Notes. For K. Added: for 

formaldehyde.

12/14/2017

Section 3

3.12

List of NIOSH 

Cautions ...

Added additional paragraph at end: If the respirator contains 

electrical components and the applicant wishes to list the respirator 

on the NIOSH approval label as intrinsically safe, first 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 approval must be received first prior to 

submitting to NIOSH.

12/14/2017

Section 3

3.13 

Private 

Labeling Third paragraph. Added: A specific section titled "S-Special ..."

12/14/2017

Section 3

3.14

User 

Instructions

First paragraph. Second sentence. Changed to read: User 

Instructions must be listed and are required to be listed on the 

assembly matrix for Supplied-Air Respirators. .

12/14/2017

Section 3

3.14

User 

Instructions

Fifth paragraph. Starting with For all tight-fitting respirators that 

must be ... Added: under a Special "S" titled listing.
8/4/2022 93 SAR SAP

3/8/2018

Section 3

3.16

Summary of 

Related 

Documents

Added to 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 filenaming conventions. Any files created in a language other than 

English will be returned unprocessed.

12/14/2017

Section 3

3.17

File Naming 

Convention

Added an additional bullet to end of bulleted list: 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.

12/14/2017

Section 4

4.4

Denial of a 

Project 

Undergoing 

NIOSH 

Evaluation

Eighth bullet. Added to item (1). Now reads: The official submittal 

either (1) requested approval of two respirators of different basic 

designs (includes submitting a supplied-air respirator with a regulator 

along with an alternate that is a regulator with a hot/cold tube in the 

same application) or (2) requested a new approval and an extension 

of approval in the same application.

12/14/2017

Section 4

4.4

Denial of a 

Project 

Undergoing 

NIOSH 

Evaluation Eleventh bullet: Added: (along with MSHA intrinsic safety) 

8/4/2022

Section 5

Supplied-Air 

Respirator Test 

Selection 

Guide Updated: Correct links to STPs

12/14/2017

Section 6

6.1 

NIOSH 

Respirator 

Application 

Checklist Added to item 9: as listed on the assembly matrix.

12/14/2017

Section 6

6.1 

NIOSH 

Respirator 

Application 

Checklist

Item 25 changed to read: All required information is present on the 

Supplied-Air Respirator drawings, as indicated on the appropriate 

checklists.
8/4/2022 94 SAR SAP

12/14/2017

Section 6

6.1 

NIOSH 

Respirator 

Application 

Checklist Item 29. Added: applicable

12/14/2017

Section 6

6.4

Self-Contained 

Breathing 

Apparatus

Deleted from item 1: B, BE, C, and CE.

Added to item 1: A, AE, B, and BE.

12/14/2017

Section 6

6.5

Supplied-Air 

Respirator

Under Respiratory Inlet Covering (Facepiece)

Deleted: or Hood.

12/14/2017

Section 6

6.7

Private Label 

Checklist for ... Item 4. Added: applicable

12/14/2017

Section 6

6.8

Document 

Examples

Item 7.

Deleted: Nuisance OV

Added: hot/cold tube

3/12/2018

Section 7

7.5

Example 

Assembly 

Matrix Replaced table to add row for drawing number.

12/14/2017

Appendix

Acronyms Added: CAR - Corrective Action Request