3/12/2018 1 APR and CBRN APR 

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

Air-Purifying Respirators and Chemical, Biological, 

Radiological, and Nuclear Air-Purifying Respirators

Under 42 CFR Part 84

Revised March 12, 2018
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Table of Contents

Introduction ..................................................................................................................................................................5

Section 1 General Information for an Air-Purifying Respirators and CBRN Air-Purifying Respirators...................7

1.1 Getting Started...............................................................................................................................................7

1.1.1 Who May Apply ...................................................................................................................................7

1.1.2 Approval...............................................................................................................................................7

1.1.3 Applicants Without a Three-character Manufacturer’s Code ............................................................7

1.1.4 Applicants Without NIOSH Approval ..................................................................................................7

1.1.5 Where to Find the Standard Application Form...................................................................................8

1.1.6 Submitting the Application..................................................................................................................8

1.1.7 Documents to Submit with the Application........................................................................................8

1.1.8 Submitting the Application and Associated Documents.....................................................................8

1.1.9 Submitting Test Samples (Hardware)..................................................................................................9

1.2 Types of Applications.....................................................................................................................................9

1.2.1 New Approval Application ...................................................................................................................9

1.2.2 Extension of Approval Application....................................................................................................10

1.2.3 Quality Assurance Approval Application ..........................................................................................14

1.2.4 Resubmission Application .................................................................................................................14

1.2.5 Amended Application ........................................................................................................................15

1.2.6 Correlation Testing Only Application ................................................................................................15

1.3 Particulate Filter Information Pertaining to APRs or CBRN APRs...............................................................16

1.3.1 Approval Label Protections and Cautions and Limitations for ARPs or CBRN APRs........................16

Section 2 Specific Instructions for Preparing an APR or a CBRN APR Application Package ..................................20

Section 3 Supplemental Information for Preparing an APR or a CBRN APR Application......................................31

3.1 Quality Assurance Documentation..............................................................................................................31

3.2 Quality Assurance Manual...........................................................................................................................31

3.3 Product Quality Control Plan and Documentation .....................................................................................32

3.4 Fees...............................................................................................................................................................33

3.5 Air-Purifying Respirator and CBRN Air-Purifying Respirator Test Fees.......................................................34

3.6 Annual (Fixed) Certification (Approval) Fees..............................................................................................37

3.7 Pay.Gov Instructions....................................................................................................................................39

3.8 Drawings for an Air-Purifying Respirator or a CBRN Air-Purifying Respirator..........................................41

3.8.1 Exploded-View Drawing for an APR or a CBRN APR.........................................................................41

3.8.2 Example of an Exploded-View Drawing for an APR or a CBRN APR.................................................42
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3.8.3 Major Subassembly Drawings for an APR or a CBRN APR ...............................................................42

3.8.4 Material Specifications on Drawings for an APR or a CBRN APR .....................................................42

3.9 Component Vendors....................................................................................................................................43

3.10 Assembly Matrix ........................................................................................................................................43

3.11 Approval Labels and Private Labels...........................................................................................................44

3.12 List of NIOSH Cautions and Limitations for an APR or a CBRN APR .........................................................45

3.13 Private Labeling Versus Private Packaging...............................................................................................45

3.14 User Instructions........................................................................................................................................47

3.15 Service Life Plan for a CBRN Air-Purifying Escape Respirator (APER) ......................................................48

3.16 Packaging Art Work and Carton Design ....................................................................................................49

3.17 Summary of Related Documents...............................................................................................................50

3.18 File Naming Conventions...........................................................................................................................50

Section 4 Approvals and Denials.............................................................................................................................54

4.1 Approval Documentation ............................................................................................................................54

4.2 Denial Documentation................................................................................................................................. 54

4.3 Denial Prior to Assignment of a Task Number............................................................................................54

4.4 Denial of a Project Undergoing NIOSH Evaluation......................................................................................55

4.5 Respirator Certification (Approval) Program Decision Review Process.....................................................56

Section 5 Respirator Tests for an Air-Purifying Respirator or a CBRN Air-Purifying Respirator ...........................57

Section 6 Air-Purifying Respirator or CBRN Air-Purifying Respirator Checklists...................................................83

6.1 NIOSH Respirator Application Checklist......................................................................................................83

6.2 Exploded-View Drawing Checklist for an APR or a CBRN APR....................................................................86

6.3 All Major Subassemblies Checklist for an APR or a CBRN APR.................................................................. 87

6.4 Supplied-Air Respirator, Also Applicable for Combination APR/SAR Applications .................................. 88

6.5 Negative Pressure Checklist for an APR or a CBRN APR ............................................................................89

6.6 Private Label Checklist for an APR or a CBRN APR......................................................................................90

6.7 Assembly Matrix Checklist for an APR or a CBRN APR .............................................................................91

Section 7 - Document Examples for an Air-Purifying Respirator or CBRN Air-Purifying Respirator......................93

7.1 Example of a Product Quality Control Plan for an APR or a CBRN APR ....................................................93

7.2 Example of a Full Facepiece Exploded-View Drawing for an APR or a CBRN APR ....................................94

7.3 Example of an Exploded-View Drawing for a Full Facepiece Combination SAR/APR...............................95

7.4 Example of an Assembly Matrix for a Combination Air-Purifying/Supplied-Air Respirator.....................96

7.5 Example of an Assembly Matrix for a Half-Mask Air-Purifying Respirator...............................................97

7.6 Example of an Assembly Matrix for a CBRN Air-Purifying Respirator.......................................................97

7.7 Example of an Approval Label for a Half-Mask Air-Purifyng Respirator...................................................97

7.8 Example of an Approval Label for a Full Facepiece CBRN Air-Purifying Respirator................................101
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7.9 Example of an Approval Label for a Filter for an Air-Purifying Respirator.................................................97

7.10 Example of an Approval Label for a Chemical Cartridge for an Air-Purifying Respirator.......................105

7.11 Example of an Approval Label for a SAR with Egress Cartridges and Filters ..........................................107

7.12 Example Label for an Abbreviated Filter for Air-Purifying Respirators...................................................109

7.13 Example Label for an Abbreviated Cartridge for an Air-Purifying Respirator............................................97

7.14 Example Label for a Gas Mask Canister for an Air-Purifying Respirator.................................................111

7.15 Example Label for a CBRN Air-Purifying Respirator Canister .................................................................. 112

Section 8 - Label Format Guidance.............................................................................................................................97

Appendix .................................................................................................................................................................. 116

Letter to All Respirator Manufacturers...................................................................................................................117

Definitions................................................................................................................................................................. 131

Acronyms...................................................................................................................................................................139
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Introduction

This document is a revision to the NIOSH Standard Application Procedure for the Approval of 

Respirators dated August 2015. It is intended to add clarity to the approval process under Title 

42, Code of Federal Regulations (CFR) Part 84 (also known as 42 CFR Part 84). It is recommended 

that applicants review the entire document before submitting a respirator for approval. 

This Standard Application Procedure (SAP) correlates with version 8 of the Standard Application 

Form (SAF). 

NPPTL has developed individual instructions for each class of respirator. The information in this 

document pertains to the approval of Air-Purifying Respirators and Chemical, Biological, 

Radiological, and Nuclear Air-Purifying Respirators. Please see the appropriate application for 

the type of respirator being submitted. 

This standard application procedure should be followed for the following classes of respirators:

Schedule 14G

• Filter Self-Rescuers;

• Gas Mask Respirators With or Without N, R, or P-Classified Filters;

• Combination Gas Mask Respirators With or Without N, R, or P Filters/Supplied-Air

Respirators;

• Tight-Fitting Air-Purifying Respirators with Chemical, Biological, Radiological, and

Nuclear Protection; and

• Air-Purifying Escape Respirators with Chemical, Biological, Radiological, and Nuclear

Protection.

Schedule 23C

• Chemical Cartridge Only Air-Purifying Respirators; and

• Combination Chemical Cartridge Air-Purifying/Supplied-Air Respirators.

Schedule 84A 

• Particulate Only Filters Air-Purifying Respirators (Not Filtering Facepieces),

• Combination Chemical Cartridge and Particulate Filter Air-Purifying Respirators, and

• Combination Chemical Cartridge and Particulate Filter Air-Purifying/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 an Air-Purifying Respirator or a Chemical, Biological, Radiological, 

and Nuclear Air-Purifying Respirator. The paragraphs are numbered to correspond with the 

sections of version 8 of the SAF. 
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Additional guidance and information related to APRs and CBRN APRs is included in the sections 

that follow and should be used as a reference.
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Section 1 General Information for Air-Purifying 

 Respirators and CBRN Air-Purifying Respirators 

Instructions for Preparing an Application Package for an Air-Purifying Respirator

or a CBRN Air-Purifying Respirator (14G, 23C, or 84A Approvals).

This guide applies strictly to Air-Purifying Respirators (APRs) and Chemical,

Biological, Radiological, and Nuclear Air-Purifying Respirators (CBRN APRs). 

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.
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However, subsequent applications will not be reviewed until the site qualification is completed 

and the initial application is approved.

The site qualification visit is only performed for new applicants (those without NIOSH approval). 

Approval holders with joint NIOSH and Mine Safety and Health Administration (MSHA) approval 

have routine site audits conducted annually. NIOSH performs routine site audits for all approval 

holders every two years. 

1.1.5 Where to Find the Standard Application Form

The standard application form, version 7 can be downloaded from the NIOSH NPPTL 

website. SAF versions 8 and 9 may be requested from the NPPTL Records Room once the 

manufacturer’s code is issued.

1.1.6 Submitting the Application

Applications should be submitted on CD-R or DVD-R. Neither rewritable CDs nor thumb drives 

will be accepted. Due to computer security policies, NIOSH cannot accept thumb drives. Only 

one application per CD-R or DVD-R will be accepted. CD-Rs and DVD-Rs will be destroyed once 

the project is closed, unless a prepaid shipping label is sent with the media.

Compressed or “zip” files are recommended for applications submitted via email. Applicants 

that choose to email the attachments to NIOSH at recordsroom@cdc.gov risk having the 

information stripped by mail routers.

Note: For part 84 APR applications, please use a standard Applicant-Assigned Reference 

Number (AAR#). For the CBRN APR application, please use the same AAR# but add the CBRN on 

the end.

Example:

Part 84 application AAR#: LWN001 CBRN APR Application AAR#: LWN001CBRN 

1.1.7 Documents to Submit with the Application

Checklists specific to the type of application being completed are included in Section 6. Fee 

schedules are included in Section 3. Tests required for APRs and CBRN APRs are included in 

Section 5. Documents must be named in accordance with the prescribed naming convention, 

using an acceptable software package. 

1.1.8 Submitting the Application and Associated Documents

The CD-R or DVD-R with the completed application form and associated documents, including 

the application fee check or pay.gov receipt, must be sent to:

NIOSH NPPTL

CV&SDB, Records Room

626 Cochrans Mill Road

Pittsburgh, PA 15236
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1.1.9 Submitting Test Samples (Hardware) 

NIOSH NPPTL

CV&SDB, Evaluation and Testing

626 Cochrans Mill Road

Pittsburgh, PA 15236

All boxes containing test samples (hardware) must be marked with the AAR# and include a 

packing slip. Test samples (hardware) submitted for a series of applications must be identified 

for each project for which it is to be used. For example, a facepiece that is to be used on three 

projects must have all three Applicant-Assigned Reference Numbers (AAR#s) on the packaging. 

If there are multiple containers, each container must be labeled with all the appropriate 

information. All sample components must be identified and labeled with the corresponding 

part numbers as listed on the assembly matrix.

If test samples (hardware) is being sent to NIOSH for the testing of multiple projects, please 

include this information in the first application where testing will be performed and label the

test samples (hardware) package with each AAR#. 

1.2 Types of Applications

The types of applications include: New Approval Application, Extension of Approval Application, 

Quality Assurance Approval Application, Amended Application, Correlation Testing Only

Application, Resubmission of New Approval Application, and Resubmission of Extension of 

Approval Application. 

If there is any doubt about the appropriate type of application to submit, call the NIOSH NPPTL 

Conformity Verification and Standards Development Branch (CV&SDB) at (412) 386-4000.

Several screens in the Standard Application Form for New Approval Applications and Extension 

of Approval Applications identify the data fields that will be entered directly into the NIOSH 

Certified Equipment List (CEL). The product description should be short and succinct for an 

accurate reporting of the respirator in the CEL.

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 For example, if an applicant submits a new respirator with two new facepieces, a 

half-mask and full facepiece that use the same new filter, NIOSH requires two 
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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). 

• 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. 

• Service Life Plan (for units that are sealed and cannot be opened prior to use 

e.g., CBRN Air-Purifying Escape Respirators (APERs)). 

• User Instructions. 

• Test Samples (Hardware). 

The following must be addressed in the “Reason for Application”: 

• Currently, U.S. Food and Drug Administration (FDA) surgical mask clearance only 

covers non-valve Air-Purifying Respirators.

• If an organization has submitted a respirator to the FDA for a pre-market notification 

to market this respirator as a medical device under 21 CFR Section 807 Subpart E, 

Premarket Notification 510(k), the organization must include a copy of the FDA 

510(K) letter indicating clearance along with the K number or the date of submission 

to the FDA. 

Note: NIOSH approval will not be issued until the medical device clearance is 

received from the FDA if the approval holder plans to market as a medical device.

• If the respirator contains or has been treated with an antimicrobial or antiviral 

treatment, include supporting documentation indicating FDA clearance, or specific 

data and third party certification that the treatment does not pose a hazard to the 

respirator user. Also, include data supporting any claims being made about the 

treatment.

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 APR. 
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• A new accessory is added to a previously approved APR. 

• 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 Accessories Previously Approved APR 

The approval holder, company 

ABC, requests the addition of 

multiple accessories to their 

previously approved APR 

described in TC-14G-xxxx.

Voice Communication Unit

Radio Unit

Welding Visor
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• An approval holder requests the addition of a component to multiple previously 

approved respirators.

Additional Component Previously Approved APRs 

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.

Submit any changes to NIOSH approved records (documents) to NIOSH. This includes minor 

changes to any document that is part of the approval record. These changes should be 

submitted for an Extension of Approval at the earliest convenience. Note, that documents not 

up-to-date in the NIOSH record could be identified during a site audit and result in a nonconformance.

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

example, a full facepiece with a new filter assembly may be submitted and approved. The 

subsequent submission of the same mask with a new filter assembly would be considered 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 

head strap arrangement on an existing APR half-mask model. 

The approval holder, company 

ABC, requests new approvals 

for various respirator family 

configurations with a new 

multi-gas cartridge.

TC-xxx-1234

TC-xxx-2345

TC-xxx-1357
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Extension of Approval Applications must contain or reference the following items as described 

in detail in Sections 2 and 3. 

• NIOSH Standard Application Form. 

• Pretest Data. 

• Simplified Drawings. 

• Assembly Matrix. 

• Draft Approval Label(s). 

• 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. 

• Service Life Plan (for units that are sealed and cannot be opened prior to use 

e.g., CBRN APERs). 

• User Instructions. 

• Test Samples (Hardware). 

In the “Reason for Application”: Describe exactly and completely the change or additions to 

the approved respirator(s) and how the change(s) will affect the previously approved 

respirator(s). Provide a succinct description of the previously approved respirator(s). For 

example, "An Extension of Approval to allow our ‘xyz’ alternate filter to be used as an 

alternative to our ‘abc’ filter on our nonpowered half-mask particulate respirators, models 123, 

456, and 789. No other components are affected. This request is for use of an alternate filter 

only." The Extension of Approval Application request 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 Instructions).

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 filter media and the details are provided. 

This Extension of Approval Application is for our model XXX N95 Air-Purifying Respirator, 

[TC-84A-9999]. The request for approval is to allow use of filter material manufactured 

by ABC, part number 12345, as an alternate to the filter material currently used which is 

manufactured by DEF, part number 67890. 
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Specifies the change(s)

This request is for use of an alternate filter media only. No other components or 

processes are affected. Both filter media are made of electrostatically-charged melt 

blown polypropylene and both pass the testing required to meet the criteria for N95 

protection. 

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

The current filter design with the DEF filter requires two separate filter layers from two 

separate roll-stocks to be assembled into the mask. The new filter material from ABC 

also uses two filter layers, but the two filter layers are bonded together on the sides so 

that both filters are on the same roll-stock.

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

• Used for new or updated Quality Assurance (QA) Manuals only. This is for current NIOSH 

approval holders only.

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

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

reason for revision. 

Note: NIOSH will only accept QA Applications that request updates to the QA Manual. No 

other requested actions will be accepted under a QA Application. QA Applications will not be 

accepted until the requestor has at least one NIOSH-Approved product.

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). 
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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 on how the respirator or 

documentation now meets NIOSH requirements, and the task number (TN) of the previously 

denied application. Failure to provide this information will result in the application being 

denied again. 

1.2.5 Amended Application

• Amended Applications are only accepted when requested by NIOSH. 

• Used for open applications with an identified inaccuracy.

• Only the portion requested by NIOSH should be submitted. 

• The AAR# and TN will remain the same. 

1.2.6 Correlation Testing Only Application

• Choose this type of application if the respirator is being submitted to be correlated with 

NIOSH Standard Testing Procedures (STPs). NIOSH will only perform correlation testing 

using one of the NIOSH Standard Test Procedures. The results of this testing cannot be 

used as pre-submission test data when submitting the respirator for NIOSH approval. No 

approval will be issued with a Correlation Testing Only Application. 

Independent or internal testing is still required prior to submittal of the application. Explain 

what testing is required, by STP number. NIOSH will only test the number of samples 

specified in the STP or 42 CFR Part 84. Specify the number of trials in the “Reason for 

Application” section.
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1.3 Particulate Filter Information Pertaining to Air-Purifying 

Respirators and CBRN Air-Purifying Respirators 42 CFR Part 84 requirements for particulate filters allow for a limited number of multiple 

approvals of one filter. 

One filter can be approved as an N, R, and P class as well as for multiple efficiency levels (95, 99, 

100). The protections listed on the approval label for the filter may identify only the class (N, R, 

P) and efficiency levels at which the filter is approved. The available multiple efficiency levels 

are:

 R100/P99 N100/R99 N99/R95 N100/R95

 R100/P95 N100/P99 N99/P95 N100/R99/P95

 R99/P95 N100/P95 HE/P100 

No other combinations are permitted. If a filter is identified using a single part number, the 

least protective class approved in either configuration will appear on the label. If the approval 

holder wants to show different classifications based upon different configurations, different 

part numbers must be used for each configuration. 

1.3.1 Approval Label Protections and Cautions and Limitations for Air- 

 Purifying Respirators and CBRN Air-Purifying Respirators

PROTECTIONS

N100-Particulate Filter (99.97% 

filter efficiency level) Effective 

against particulate aerosols free 

of oils; time use restrictions may 

apply.

R100-Particulate Filter 

(99.97% filter efficiency level) 

Effective against all 

particulate aerosols; time use 

restrictions may apply.

P100-Particulate Filter 

(99.97% filter efficiency 

level) Effective against all 

particulate aerosols. 

N99-Particulate Filter (99% filter 

efficiency level) Effective against 

particulate aerosols free of oil; 

time use restrictions may apply. 

R99-Particulate Filter (99% 

filter efficiency level) Effective 

against all particulate 

aerosols; time use restrictions 

may apply.

P99-Particulate Filter (99% 

filter efficiency level) 

Effective against all 

particulate aerosols. 

N95-Particulate Filter (95% filter 

efficiency level) Effective against 

particulate aerosols free of oil; 

time use restrictions may apply. 

R95-Particulate Filter (95% 

filter efficiency level) Effective 

against all particulate 

aerosols; time use restrictions 

may apply.

P95-Particulate Filter (95% 

filter efficiency level) 

Effective against all 

particulate aerosols. 

CBRN - Chemical, Biological, Radiological, and Nuclear
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AG - Acid Gas (gas mask only) 

AM - Ammonia CD - Chlorine Dioxide CF - Continuous Flow 

CL - Chlorine CN - Chloroacetophenone CO - Carbon Monoxide 

CS - Chlorobenzylidene Malononitrile DE - Demand 

EO - Ethylene Oxide ESC - Escape FM - Formaldehyde 

HC - Hydrogen Chloride HF - Hydrogen Fluoride HN - Hydrogen Cyanide 

HS - Hydrogen Sulfide MA - Methylamine MV - Mercury Vapor 

ND - Nitrogen Dioxide OV - Organic Vapor SB - Supplied-Air Abrasive Blast 

PH - Phosphine SA - Supplied-Air SD - Sulfur Dioxide 

TDI - Toluene-2, 4-diisocyanate VC - Vinyl Chloride 

CBRN - CAP 1, 2, 3, etc. - Capacity N Minutes 

Escape-Only CBRN 15, 30, 45, etc. - Capacity N Minutes 

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 - 7.1 Grade D or higher quality.

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

G If airflow is cut off, switch to filter and/or cartridge or canister and immediately exit to 

clean air.

H Follow established cartridge and canister change schedules or observe ESLI to ensure 

that cartridges and canisters are replaced before breakthrough occurs.

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.

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.

P NIOSH does not evaluate respirators for use as surgical masks.

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning.

AA This respirator is to be used for escape-only and will protect against the inhalation of 

certain respiratory hazards.

BB Not for use for entry into atmospheres immediately dangerous to life or health.
3/12/2018 18 APR and CBRN APR 

CC For entry, do not exceed maximum use concentrations established by regulatory 

standards.

LL This respirator contains filter or cartridge components that are not approved for all 

protections in all configurations. Check the specific row on the NIOSH approval label to 

ensure proper use.

CBRN - SPECIFIC CAUTIONS and LIMITATIONS

R Some CBRN agents may not present immediate effects from exposure, but can result in 

delayed impairment, illness, or death. 

T Direct contact with CBRN agents requires proper handling of the respirator after each 

use and between multiple entries during the same use. Decontamination and disposal 

procedures must be followed. If contaminated with liquid chemical warfare agents,

dispose of the respirator after decontamination.

U The respirator should not be used beyond six (6) hours after initial exposure to chemical 

warfare agents to avoid possibility of agent permeation.

V Not for use in atmospheres immediately dangerous to life or health or where hazards 

have not been fully characterized.

W Use replacement parts in the configuration as specified by the applicable regulations 

and guidance.

X Consult manufacturer’s User Instructions for information on the use,storage, and

maintenance of these respirators at varioustemperatures.

Y The respirator providesrespiratory protection against inhalation of radiological and

nuclear dust particles. Procedures for monitoring radiation exposure and full radiation

protection must be followed. 

Z If during use, an unexpected hazard is encountered such as a secondary CBRN device,

pockets of entrapped hazard or any unforeseen hazard, immediately leave the area for

clean air

DD Thisrespirator providesrespiratory protection against inhalation of certain gas and vapor

chemical agents, biological particulates, and radiological and nuclear dust particles. This

respirator provides limited dermal (skin) protection to the head area and eyes.

EE Eye irritation may be experienced based upon the CBRN agent and exposure

(concentration and duration).

JJ CBRN Agents, depending on how they are used, may provide disabling effect as a result

of skin exposure.

GG Direct contact with CBRN agents requires proper handling of the respirator after use.

Correct disposal procedures must be followed.

HH When used at defined occupational exposure limits, the rated service time cannot be

exceeded. Follow established canister change outschedules or observe End-of-ServiceLife Indicators to ensure that canisters are replaced before breakthrough occurs.

II Thisrespirator provides protection from certain inhalation hazards associated with fire.

NN This respirator is a one-time-use device with no replaceable parts. Discard after use

regardless of contaminant exposure.
3/12/2018 19 APR and CBRN APR 

QQ Use in conjunction with personal protective ensemblesthat provide appropriate levels of

protection against dermal hazard. Failure to do so may result in personal injury even

when the respirator is properly fitted, used, and maintained.

UU The respiratorshould not be used beyond eight (8) hours after initial exposure to chemical

warfare agentsto avoid possibility of agent permeation. If liquid exposure is encountered,

the respirator should not be used for more than two (2) hours. 
3/12/2018 20 APR and CBRN APR 

Section 2 Specific Instructions for Preparing an Air-Purifying 

Respirator or a CBRN Air-Purifying Respirator

Application Package 

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

sections on version 8 of the Standard Application Form (SAF). 

1 Project Reference Numbers (Section C.1)

Enter the three character NIOSH-Assigned manufacturer’s code.

Check box if the applicant currently has a NIOSH-Approved product. 

Assign a unique reference number to this application. 

This reference number must start with the three character NIOSH-Assigned manufacturer’s 

code. There is no character limit on this reference number. This number must appear on 

each hardware sample package and the payment. Never reuse the Applicant-Assigned 

Reference Number (AAR#) except on Amended Applications requested by NIOSH.

NIOSH assigns a unique Task Number (TN) to each project. This number is emailed to the 

applicant once the application is received along with accompanying documents, check or 

payment confirmation, and test samples (hardware). All inquiries must refer to either the 

NIOSH-Assigned TN or the AAR#.

2 Type of Application (Section C.2)

Select from: New Approval Application, Resubmission of New Approval Application, Extension 

of Approval Application, Resubmission of Extension of Approval Application, Quality Assurance 

Application, Correlation Testing Only Application, or Amended Application. 

New Approval Application

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

protection requested for an existing NIOSH-Approved respirator.

Resubmission of New Approval Application

• Resubmission 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.
3/12/2018 21 APR and CBRN APR 

• A change is made to an approval label, assembly matrix, User Instructions, or 

drawings.

• A private label request is made.

• A product is made obsolete.

Resubmission of Extension of Approval Application

• Resubmission 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.
3/12/2018 22 APR and CBRN APR 

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.

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 Air-Purifying Respirator since this application applies only to Air-Purifying 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? 

Not applicable.

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

If Yes, specify the applicable AAR# or TN.
3/12/2018 23 APR and CBRN APR 

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

approved until the first application is approved 

If there are two or more applications that use the same assembly matrix, check the “yes” box 

and identify all subsequent applications in the Approval History. The second and subsequent 

applications using the same assembly matrix cannot be processed until the first application is 

approved. Additionally if a drawing is currently under review at NIOSH and a separate matrix is 

submitted, the current application should indicate that the project is dependent on the prior project and 

applicants should list the applicable TN.

9 Reason for Application (Section C.9)

Provide a complete, concise, descriptive reason for the application. Do not provide information 

relating to respirator use or future respirator development. This is the information that will 

appear in the CEL. 

The following must be addressed in the “Reason for Application”:

• If the organization has submitted this APR respirator to the FDA for a pre-market 

notification to market this respirator as a medical device under 21 CFR Section 807 

510(K), include a copy of the FDA 510(K) letter indicating clearance, including the K 

number or the date of submission to the FDA.

Note: NIOSH approval will not be issued until the medical device clearance is 

received from the FDA if the approval holder plans to market as a medical device.

• If the APR contains or has been treated with an antimicrobial or antiviral treatment, 

include supporting documentation indicating FDA clearance, or specific data and 

third party verification that the treatment does not pose a hazard to the respirator 

user. Also, include data supporting any claims being made about the treatment.

• 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.
3/12/2018 24 APR and CBRN APR 

Correlation Testing Only Applications must state which NIOSH Standard Testing Procedures is to 

be used and indicate how many trials are requested. Special correlation tests that are not 

consistent with a NIOSH Standard Testing Procedures will not be conducted unless previously 

agreed upon by NIOSH. An approval will not be issued with a Correlation Testing Only 

Application.

Resubmittals must state the modification(s) that was (were) made to address the 

rejection/denial, and demonstrate that the respirator or documentation now meets all 

requirements.

10 Approval History (Section C.10)

Provide additional information on Approval History and any other information pertaining to this 

application. Do not list additional requests in the Approval History. 

If the application is one of a series being submitted, clearly list the AAR#s of all applications in 

the series. Include a suggested processing order. Include an explanation how the applications 

build upon each other. When using a common assembly matrix for the entire series of 

applications, place the assembly matrix in the last application of the series and reference the 

application in which it is located in all applications in the series. Applications in a series will not 

be approved until the entire series is complete. 

List the application TN where the respirator was last tested by NIOSH.

Example of a Well-Written Approval History for an Air-Purifying Respirator: 

The new filter media is documented on revised specification sheet ZM-FL-A02 Rev A.

The change is documented in the respirator’s bill of materials (Item 2) on page 3 of 

drawing 103-01 Revision M.

Testing of the Air-Purifying Respirator shows it meets the requirements of 42 CFR Part

84 for breathing resistance and efficiency.

The other filter layers have not changed since this respirator was granted NIOSH 

approval under TN-xxxxx. Happy Breathing Company is relying on the breathing 

resistance and filter efficiency data accompanying this submission, AAR#ph24, to obtain 

this approval.

This change will be applicable to the XXX respirator and private labels YYY and 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 
3/12/2018 25 APR and CBRN APR 

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: Not applicable for APRs. 

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 APR if seeking CBRN approval. 

Is testing required?

Yes or No. 

Return sample hardware?

Yes or No. 

Note: If No, NIOSH will dispose of the equipment.

Source of submitted samples – Choose from dropdown options: 

Prototype, Regular Production Unit, Correlation Test Sample. 

If no testing is required, please provide the reason.

Facepiece type – Choose from the dropdown options:

Filtering Facepiece, Full Facepiece, Half-Mask, Quarter-Mask, Mouthpiece, Hood, 

Helmet, or Tight-Fitting Full Facepiece with Neckdam Seal.

Fit – Choose from the dropdown options: 

Tight-Fit, Loose-Fit, Both Tight- and Loose-Fit, or Mouthbit.

Is this respirator fit checkable?

Yes or No. 

If the respirator contains electrical components, have the components been approved by MSHA 

for intrinsic safety?

Yes, No, or Not Applicable. 

Note: If this respirator is to be used for underground mine use and has electrical 

components, MSHA intrinsic safety must be received prior to submitting to NIOSH.

Does the respirator have an inhalation valve?

Yes or No. 
3/12/2018 26 APR and CBRN APR 

Does the respirator have an exhalation valve?

Yes or No. 

Move to Air-Purifying Questions

Type of AP Respirator – Choose from dropdown options: 

Particulate Filtering, Gas/Vapor Removing, or Combination Gas/Vapor Removing and 

Particulate Filtering.

Mask Power – Choose from dropdown options: 

Unpowered, Powered, or Both Powered and Unpowered Use.

How many filters?

Indicate the number of filters.

Are the filters replaceable? 

Yes or No. 

Filter Location – Choose from dropdown options: 

Facepiece-Mounted, Chest-Mounted, Back-Mounted, Belt-Mounted, Hood-Mounted, or 

Helmet-Mounted.

Does this respirator protection cover more than a single gas?

Yes or No. 

Does the respirator use cartridges or canisters? 

Indicate either cartridges or canisters.

How many cartridges or canisters?

Indicate number of cartridges or canisters.

Cartridge or canister location – Choose from dropdown options: 

Facepiece-Mounted, Chest-Mounted, Back-Mounted, Belt-Mounted, Hood-Mounted, or 

Helmet-Mounted.

Can the canister or cartridge be replaced?

Yes or No. 

Does the canister or cartridge have an ESLI (EOSL)? 

Yes or No. 

Also provide a description of the respirator(s).
3/12/2018 27 APR and CBRN APR 

12 Intended Protection and Safety Design (Section C.12)

Air-Purifying Respirator Only:

State all protections for which approval is requested. NIOSH does not permit the use of any 

form of chromium-impregnated sorbent material for nuisance levels due to the suspected 

carcinogenic effects. 

State all contaminants for which approval is requested. Chemical cartridges (23C or 84A) must 

identify the specific contaminants for which approval is desired (e.g., chlorine, chlorine dioxide, 

etc.). Gas masks (14G) can list specific contaminants for which approval is requested, or may 

use “Acid Gas” as a protection if the protection applies. 

Note: NIOSH does not permit the use of any form of chromium-impregnated sorbent material 

due to the suspected carcinogenic effects. In the case of CBRN Air-Purifying Respirators (APRs), 

identify the capacity level requested as CAP 1, 2, 3, or other. For CBRN Air-Purifying Escape 

Respirators (APERs), identify the rated duration as CBRN Escape 15, 30, or other.

Combination Air-Purifying Atmosphere-Supplying Respirators: 

Follow the requirements of Air-Purifying Respirators. In addition, for the atmosphere-supplying 

part of the combination respirator, 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. Any questions regarding the need for joint approval, please call 

NIOSH NPPTL at 412-386-4000. Note: If this respirator is to be used for underground mine use 

and has electrical components, MSHA intrinsic safety must be received prior to submitting to 

NIOSH.

13 Pre-Submission Performance Test Data and Statements (Section 

C.13)

Respirator pre-submission performance test data must accompany each application and must: 

• Specify components used for test configuration by part number.

• Show units of measure for all test data (units of measure must match 42 CFR Part 84 

subparts I through N criteria).

• Submit copies of actual test data with all results and conclusions.

To verify which tests need to be performed as part of the pre-submission testing, please refer 

to the Respirator Test Selection Guide. NIOSH expects that applicants will have performed each 
3/12/2018 28 APR and CBRN APR 

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 resistance values for all of the related Air-Purifying Respirator

configurations. This data must be representative of each complete respirator assembly seeking

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

combinations reported by the applicant if multiple sizes or configurations are submitted.

Note for efficiency or penetration testing: 

For N series filters, three samples must be tested to full loading. The type of penetration is 

then determined, and the remaining 17 samples can be tested until they reach the same point 

of maximum penetration (highest point seen in the first three samples). Refer to the Standard 

Testing Procedures for N series filters. 

For P series filters, if the filter efficiency is decreasing when the 200 mg challenge point is 

reached, the test will be continued until there is no further decrease in efficiency (see the 

Standard Testing Procedures for P series filters). 

When an end-of-service-life indicator (ESLI) is included on an Air-Purifying Respirator due to 

poor warning properties of a gas or vapor, include information:

• Demonstrating that the ESLI is a reliable indicator of sorbent depletion, 

• On the effects of any industrial chemical interference with the indicator, 

• On the shelf life of the indicator, 

• Affirming that the ESLI is visible to the user when worn, and

• Affirming that the ESLI will withstand normal handling without damage. 

Any respirators that have an ESLI should list caution “S” on the approval label. Also, the User 

Instructions must contain a special section that is labeled “S-Special or Critical User 

Instructions” where the ESLI information is contained. See Approval Labels in Section 7 for an 

example.

14 Model Numbers and Product Trade Names (Section C.14)

The information provided in this field is how the product will appear in the Certified Equipment 

List. 

A product trade name that uniquely identifies the respirator or family is required. This name 

will be listed in the Certified Equipment List for public reference. In version 8 of the 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 Part 84 standards.
3/12/2018 29 APR and CBRN APR 

15 Test Samples (Hardware) (Section C.15)

Regular production units submitted for approval must be the result of actual manufacturing 

processes (42 CFR Section 84.11(e)). Applications will be denied if the test samples (hardware) 

provided for testing did not go through the manufacturer’s normal assembly, inspection, and 

test processes. Applications may be denied even if the component that failed is not related to 

the “Reason for Application.” 

Use the Respirator Test Selection Guide to determine the minimum number of hardware 

samples required for testing. Submit a sufficient number of hardware samples for testing at the 

time of application. The hardware samples to be used for testing must be sent under a separate 

cover from the application. In the application and on the packing slip with the hardware 

samples, list the item by part number and description, and indicate the quantity submitted for 

testing. Include a copy of the User Instructions in the box or shipping container with the 

hardware samples to be used for testing. 

The outside of each box or shipping container and packing slip(s) should clearly indicate "Test 

Samples/Hardware" along with the name of the applicant, AAR#(s), part number(s), and 

quantity(ies). The hardware samples to be used for testing and any additional hardware

samples requested by NIOSH must clearly show the part number on each item, regardless of 

how it is packaged. If additional hardware samples to be used for testing are requested by 

NIOSH, mark the shipment to the attention of the NIOSH employee requesting the samples. 

Include the AAR#, TN, and state “Additional Test Samples” on the outside of the box or shipping 

container. Cross-referenced lists will not be accepted.

The applicant must submit prepaid return shipping labels or provide other return means with 

the hardware samples for any materials to be returned upon completion of testing. “Please 

Return Samples” should be indicated on the packing slip. If NIOSH denies an application based 

upon documentation issues, the application, and in most cases, all hardware samples will be 

returned. 

NIOSH does not retain hardware samples for any completed projects, approved or denied. The 

hardware samples will be promptly destroyed unless the applicant indicates the samples should 

be returned and prepaid return shipping instructions are provided. NIOSH is not responsible for 

customs charges. The applicant is responsible for all shipping costs and making all 

arrangements to clear the hardware samples through customs when shipping hardware

samples to be used for testing to or from NIOSH.

The test sample hardware submitted with the application will be tested. No substitutions, 

additions, or deletions are permitted by the applicant once NIOSH receives the application.

If NIOSH evaluators determine a need for additional testing, additional test samples (hardware) 

may be requested.
3/12/2018 30 APR and CBRN APR 

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. 
3/12/2018 31 APR and CBRN APR 

Section 3 Supplemental Information for Preparing an Air- 

 Purifying Respirator or a CBRN Air-Purifying 

 Respirator 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 QA Application, submit only the sections that have 

been revised and an updated revision history sheet. 

3.2 Quality Assurance Manual

Submit a Quality Assurance Manual that documents the following elements at a minimum: 

A. Statement of Quality Assurance. 

 - Upper management approval of the manual (usually a signature).

- A revision history sheet showing the 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).
3/12/2018 32 APR and CBRN APR 

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. 

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 to 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 Air-Purifying Respirator drawing.

F. Assembly matrix.
3/12/2018 33 APR and CBRN APR 

3.4 Fees

An application fee of $200 is required at the time of submission for all approval requests. 

Checks are to be made payable to NIOSH, dated less than 30 days prior to the submission date, 

and contain the AAR#. The specific AAR# for the application must be written on the check. 

Checks older than 30 days may be returned. Separate checks are required for each application 

submitted. Do not issue multiple application fees on one check. Otherwise, checks will be 

returned and application processing delayed.

NIOSH will not begin processing the request until all items (application, check, and test samples 

(hardware)) are received. If a domestic applicant utilizes Pay.Gov, send a copy of the Pay.Gov 

receipt to the NIOSH NPPTL Records Room to facilitate linking the payment to the approval 

request. 

As part of the Initial Review Process, an estimate of the costs anticipated to be incurred during 

the evaluation will be provided. An email from the initial reviewer will be sent to the applicant 

towards the end of the Initial Review Phase. 

This estimate is prepared based on the “Reason for the Application,” the number of approvals 

affected, and the assigned tests. In the event other testing or other additional cost items are 

identified after the acceptance of the original estimate, the company will be contacted and an 

addendum to the estimate will be forwarded for acceptance.

Once the applicant has provided authorization to the initial reviewer via email, the evaluation 

can begin. During the Final Review Phase, an invoice for all fees, including testing of equipment, 

incurred in the processing of an application will be generated. Invoices will contain specific 

payment instructions and identify authorized methods of payment, and will be provided to the 

approval holder for payment. 

Respirator Approval Application-Based fees are as follows:

Administrative Fees:

Fee Type Legal Citation Amount Due Date

Application 42 CFR 

§84.20(b)(1) $200 per application submitted. 

Upon receipt of any application 

request. To be submitted with 

application.

Approval 42 CFR 

§84.20(b)(1)

$100 per each certificate of approval 

issued.

Upon receipt of the invoice.

Approval 

Modification

42 CFR 

§84.20(b)(1)

$50 per each certificate of approval 

modified. 

Upon receipt of the invoice. 

Site 

Qualification

42 CFR 

§84.20(b)(3)

• Existing approval holder, paper review:

o $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. 
3/12/2018 34 APR and CBRN APR 

Note: For any modification to an existing approval, such as changes to User Instructions or 

PQP, the approval modification fee will be charged for all the approvals affected by this change. 

For example, if the User Instructions are revised due to a change in a specific respirator, but the 

same User Instructions are used on a family of respirators (example: family consists of 20 

approvals), the approval modification fee of $50 will be charged for all the approvals under that 

family of respirators (20 X $50 = $1,000).

Testing fees will be charged in accordance with the following fee tables and will be due upon 

receipt of the invoice. The final letter (approval or denial) will be issued to the primary contact 

once all reviews are complete. The invoice is to be paid within 30 days after receipt.

3.5 Air-Purifying Respirator and CBRN Air-Purifying Respirator Test 

 Fees 

All of these tests may not apply to the specific type of respirator being submitted. These apply 

only to Air-Purifying Respirators. 

Air-Purifying Respirator Fees: 

0003 Exhalation Resistance $150.00

0004 Exhalation Valve Leakage $300.00

0005 IAA Fit Test $1,800.00

0005* Qualitative Fit Testing $1,800.00

0005A IAA Fit Test for Full Facepieces $1,800.00

0006 IAA Fit Test for Half-Masks $1,800.00

0007 Inhalation Resistance $150.00

0014 Leakage of Drink Tubes and Accessories $300.00

0033A Ammonia Service Life Testing for Cartridges $750.00

0033B Ammonia Service Life Testing for Canisters $750.00

0034 Carbon Monoxide Service Time $750.00

0035 Chlorine Service Time Testing $750.00

0036 Chlorine Dioxide Service Time Testing $750.00

0037 CN Service Time Testing $2,400.00

0038 Ethylene Oxide Service Time Testing $450.00

0039A Formaldehyde Service Time Testing for Cartridges $750.00

0039B Formaldehyde Service Time Testing for Canisters $750.00

0040 Hydrogen Chloride Service Time Testing $500.00

0041 Hydrogen Cyanide $1,800.00

0042 Hydrogen Fluoride Service Time Test $750.00

0043A Hydrogen Sulfide Service Time Testing for Cartridges $750.00

0043B Hydrogen Sulfide Service Time Testing for Canisters $750.00

0044 Mercury Vapor Service Time Testing $2,400.00

0045A Methylamine Service Time Testing for Cartridges $450.00

0045B Methylamine Service Time Testing for Canisters $450.00
3/12/2018 35 APR and CBRN APR 

0046A Organic Vapor (CCL4) Service Time Cartridges $450.00

0046B Organic Vapor (CCL4) Service Time Canisters $450.00

0047 Phosphine Service Time Testing $750.00

0048A Sulfur Dioxide Service Time Testing Cartridges $450.00

0048B Sulfur Dioxide Service Time Testing Canisters $450.00

0050 CS Service Time Testing $2,400.00

0051 Dioctyl Phthalate (DOP) P100 $1,200.00

0052 Dioctyl Phthalate (DOP) P99 $1,200.00

0053 Dioctyl Phthalate (DOP) P95 $1,200.00

0054 Dioctyl Phthalate (DOP) R100 $1,200.00

0055 Dioctyl Phthalate (DOP) R99 $1,200.00

0056 Dioctyl Phthalate (DOP) R95 $1,200.00

0057 NaCl (Salt) Particulate Testing N100 $1,200.00

0058 NaCl (Salt) Particulate Testing N99 $1,200.00

0059 NaCl (Salt) Particulate Testing N95 $1,200.00

0060 Determination of End-of-Service-Life Indicator Drop $300.00

0061 Determination of End-of-Service-Life Indicator Visibility $300.00

0062 Nitrogen Dioxide Service Time Testing $750.00

0066 Determination of End-of-Service-Life Indicator $300.00

0067 Qualitative Fit Test, Bitrex or Saccharine $1,800.00

New Site Qualification Fee, Existing Manufacturer $400.00

* Quantitative fit testing, using corn oil, may be performed in place of the qualitative fit testing 

performed with Isoamyl Acetate (IAA), at the request of the applicant.

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
3/12/2018 36 APR and CBRN APR 

Air-Purifying CBRN Respirators:

0301 Cyclohexane (Set of 9 Canisters) $1,000.00

0302 Cyanogen Chloride (Set of 9 Canisters) $2,400.00

0303 Hydrogen Cyanide (Set of 9 Canisters) $2,400.00

0304 Phosgene (Set of 9 Canisters) $1,400.00

0305 Hydrogen Sulfide (Set of 9 Canisters) $800.00

0306 Sulfur Dioxide (Set of 9 Canisters) $800.00

0307 Ammonia (Set of 9 Canisters) $1,000.00

0308 Nitrogen Dioxide (Set of 9 Canisters) $1,200.00

0309 Phosphine (Set of 9 Canisters) $1,000.00

0310 Formaldehyde (Set of 9 Canisters) $1,000.00

0311 NPPTL Environmental Conditioning $16,000.00

0311 NPPTL Modified Environment Condition Minus 125 Canisters $8,000.00

0312 Field of View $1,000.00

0313 Communications $5,000.00

0314 Fogging $3,000.00

0316 Haze, Luminous Transmittance and Abrasion $2,000.00

0350 GB (SMARTMAN) Qualifier LAT(QLAT) Only1 $9,142.00

0351 HD (SMARTMAN) QLAT Only1 $9,142.00

0350 GB (SMARTMAN) Remainder LAT (RLAT)1 $9,142.00

0351 HD (SMARTMAN) RLAT Only1 $9,142.00

0350/0351 Aerosol process TDA-99M (SMARTMAN) Only1 $600.00

0352 Laboratory Respirator Protection Level (LRPL) $20,000.00

0352 Partial LRPL $16,000.00

0353 Weight and Diameter $200.00

0353 Canister Thread Analysis $1,065.00

Note: 1 Testing Performed at RDECOM. 

Air-Purifying Escape CBRN Respirators: 

0401 Cyclohexane (Set of 9 Canisters) (APER only) $1,000.00

0402 Cyanogen Chloride (Set of 9 Canisters) (APER only) $2,400.00

0403 Hydrogen Cyanide (Set of 9 Canisters) (APER only) $2,400.00

0404 Phosgene (Set of 9 Canisters) (APER only) $1,400.00

0405 Hydrogen Sulfide (Set of 9 Canisters) (APER only) $800.00

0406 Sulfur Dioxide (Set of 9 Canisters) (APER only) $800.00

0407 Ammonia (Set of 9 Canisters) (APER only) $1,000.00

0408 Nitrogen Dioxide (Set of 9 Canisters) (APER only) $1,200.00

0409 Phosphine (Set of 9 Canisters) (APER only) $1,000.00
3/12/2018 37 APR and CBRN APR 

0410 Formaldehyde (Set of 9 Canisters) (APER only) $1,000.00

0411 NPPTL Environmental Conditioning $20,000.00

0312 Field of View $1,000.00

0414 Fogging $4,000.00

0450 GB (SMARTMAN) Qualifier LAT(QLAT) Only1 $9,142.00

0451 HD (SMARTMAN) QLAT Only1 $9,142.00

0450 GB (SMARTMAN) Remainder LAT (RLAT) Only1 $9,142.00

0451 HD (SMARTMAN) RLAT Only1 $9,142.00

0450/0451 Aerosol Process TDA-99M (SMARTMAN)1 $600.00

0452 Laboratory Respirator Protection Level (LRPL) $20,000.00

0452 Partial LRPL $16,000.00

0454 Human Subject Breathing Gas Test $3,500.00

0417 Flammability, Heat Resistance, CO Protection Only $14,000.00

Note: 1 Testing Performed at RDECOM. 

Test Fees to be Charged for New and Unspecified Tests:

All Wildland Firefighting Respirator Testing

$500/day for testing.

$100/day per human test subject.

$1,300/day for doctors and medical staff.

A single payment (check or pay.gov) for multiple invoices is allowed. Include the AAR#s for each 

associated application on the check or the pay.gov receipt so they will be properly credited. 

Separate payments (check or pay.gov) will also be allowed for each application invoice. For 

application fee invoices, included the TN number(s) associated with the payment. To indicate a 

final payment for a specific application(s), add a -F after the TN number(s) (TN-nnnn-F). 

3.6 Annual (Fixed) Certification (Approval) Fees 

Annual (fixed) certification (approval) fees will be invoiced to approval holders who hold active 

or obsolete certificates of approval. Invoices will be sent in September with payment due by 

October 30 of the applicable year. Invoices will itemize the number of manufacturing sites and 

approvals and apply the fees per the following table: 

Respirator Certification (Approval) Fee Schedule A—Annual (Fixed) Fees

Fee Type Legal Citation Amount Due Date

Maintenance of 

Product 

Performance 

(Product Audit)

42 CFR 

§84.20(b)(5)

• Annual fee: $761 per each approval holder. 

• Variable fee: as billed by NIOSH based on the 

respirators chosen to be tested each year. 

October 30 of 

applicable year. 

Records 

Maintenance

42 CFR 

§84.20(b)(1)

$50 per every listed1 approval on file with 

NIOSH on July 1st of each year. 

October 30 of 

applicable year. 
3/12/2018 38 APR and CBRN APR 

Quality Assurance 

Maintenance 

(Site Audit) 

42 CFR 

§84.20(b)(4) 

• Annual fee: $3,000 per every manufacturing 

site registered with NIOSH. 

• Variable fee2

: 

▫ 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 C.F.R. 

§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. 
3/12/2018 39 APR and CBRN APR 

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 ApplicantAssigned 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.
3/12/2018 40 APR and CBRN APR 

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. 
3/12/2018 41 APR and CBRN APR 

3.8 Drawings for an Air-Purifying Respirator or a CBRN 

Air-Purifying Respirator

All drawings must be in English. Drawings are accepted in Adobe PDF, ProEngineer, Autodesk, 

Smart Draw, and Corel Draw. Drawings should be named using a unique identifier of the 

organization’s choice, R for drawing, the revision level (e.g., a, b, c, etc.), and the file extension 

representing the software program (e.g., nnnnRa.dwg). However, it is suggested that applicants 

also use their three character manufacturer’s code in the drawing filenames (XXXnnnnRa.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 for an Air-Purifying Respirator or a CBRN 

 Air-Purifying Respirator

For Air-Purifying Respirators, the exploded-view drawing must include the complete respirator 

with critical or major dimensions, materials, characteristics, and all components including 

accessories as listed on the Air-Purifying 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 exploded-view drawing to group the smaller parts together into one major 

subassembly. If the profile of a component changes, i.e., from a facepiece to a facepiece with a 

side window, the components must be shown separately as 1a, 1b, 1c, etc.
3/12/2018 42 APR and CBRN APR 

3.8.2 Example of an Exploded-View Drawing for an Air-Purifying Respirator or 

 a CBRN Air-Purifying Respirator 

3.8.3 Major Subassembly Drawings for an Air-Purifying Respirator or a CBRN 

Air-Purifying 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 an Air-Purifying Respirator or 

 a CBRN Air-Purifying Respirator 

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, the items

would be identified as aluminum, butyl rubber, etc. The phrase “or equivalent” should not be 

used.
3/12/2018 43 APR and CBRN APR 

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 the 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 example, for an Air-Purifying Respirator where the schedule# is 

84A, followed by the AAR# MOR699, and the TC number cell for the first row (a) of the 

new approval, the numbering convention would be 84A-MOR699a. The second row 

would be numbered 84A-MOR699b, the third row would be numbered 84A-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 Air-Purifying 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. 
3/12/2018 44 APR and CBRN APR 

• 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 used to indicate a change to any associated 

document with that component.

- = A component or respirator designated by the approval holder as obsolete. Do 

 not use “double dash.” An obsolete item must be shown on the matrix as 

 obsolete for the TC number/part number combination at least once. Once 

 organizations have submitted an assembly matrix with obsolete items, they may 

 drop these items from the matrix in future submissions. If obsoleting an 

 approval, dash marks must appear in every block that a component for that 

 approval was marked. 

A = Accessory item. An item that does not affect the ability of a respirator to meet 

 the requirements of 42 CFR Part 84. The approval remains in effect whether the 

 accessory is used or not. 

For easier review and evaluation, it is recommended that applicants lightly shade the rows and 

columns containing new or redesigned (N or R) components. If no cells are marked N or R, the 

applicant should reconsider whether an application for approval is required. If in doubt, call 

NIOSH NPPTL Conformity Verification and Standards Development Branch at (412) 386-4000.

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 Air-Purifying Respirators. The list of protections must be in the same order and 

identical to the matrix. Submit draft versions of the appropriate labels. 
3/12/2018 45 APR and CBRN APR 

Labels must be submitted for a New Approval and for an Extension of Approval when the 

components change. Labels must be created in Excel (97 or later) and follow the format of the 

examples. Accessories may be listed on the approval label, but are not required. NIOSH will 

accept draft labels with the location of the Health and Human Services (HHS) and NIOSH logos 

noted. Logos are available on the NIOSH NPPTL homepage. The applicant is responsible for 

inserting the logos during label production. Approval labels may not contain future submittals 

or show unapproved assemblies.

3.12 List of NIOSH Cautions and Limitations for an Air-Purifying 

 Respirator or a CBRN Air-Purifying Respirator Chemical Cartridge (no filter): A, B, C, H, I*, J, K*, L, M, N, O, S*, AA*, FF* 

Chemical Cartridge (with filter): A, B, C, H, I*, J, K*, L, M, N, O, P, S*, AA*, FF* 

Gas Mask: A, H, I*, J, L, M, N, O, P, S*, AA*, BB, CC, FF* 

SAR combination (with cartridge and/or filter): A, B, C, D, E, G, H, I*, J, K*, L*, M, N, O, P, S*, 

 AA, FF*

CBRN APR: A, I*, J, L, M, O, R, S*, T, V, W, X, Y, Z, CC, HH, QQ, UU

CBRN APER: A, I*, J, L, M, O, R, S*, X, AA*, DD, EE, GG, II*, JJ, NN

* Note: 

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.

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

label version. 

AA Depending on use or design such as a mouthbit. 

FF If face-mounted cartridge or canister only.

II Applies only with CO protection. 

Cautions and limitations may vary or additional ones may apply depending on design and

performance. Combination units usually require all cautions and limitations from both types. 

Cautions and limitations for Filter Self-Rescuers (FSR) will be determined based on design and 

use.

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 
3/12/2018 46 APR and CBRN APR 

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, an Extension of Approval 

Application must be submitted showing this change in the assembly matrix and all labeling. 

A Special Cautions and Limitations “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 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.
3/12/2018 47 APR and CBRN APR 

3.14 User Instructions

User Instructions must be submitted to NIOSH for Air-Purifying Respirators. User Instructions 

must be listed on the assembly matrix for Air-Purifying 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. 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 cautions and limitations “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-84A-nnnn.”

If Special or Critical User Instructions or specific use limitations are stated, these items will be 

reviewed to ensure the items are correct and appropriate.

For all tight-fitting respirators that must be fit tested prior to use, the following Occupational 

Safety and Health Administration (OSHA) reference must be included in the User Instructions:

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.
3/12/2018 48 APR and CBRN APR 

For all Air-Purifying Respirators that include a nuisance level odor removal layer in the filter or 

other design, the following must be included in the User Instructions under a Special “S” titled 

listing: 

This respirator offers nuisance level relief from (type of odor (such as organic vapors)) 

that are below the permissible exposure limit (PEL). Nuisance level refers to 

concentrations not exceeding the OSHA PEL or other government occupational exposure 

limits, whichever is lower. 

Requirements Specific to Air-Purifying Respirators

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.

For all respirators equipped with passive end-of-service-life indicators, wording that emphasizes 

visibility without manipulation to the respirator, cartridges, filters, or facepiece may be used.

For example: 

S - Special or Critical User Instructions: This respirator is equipped with a passive endof-service-life indicator (ESLI). The ESLI must be readily visible to the wearer of this 

respirator without manipulation of the respirator, cartridges, facepiece, or indicator. If 

users cannot readily see the indicator, they should not wear the respirator. 

In addition, information necessary to explain the color change or any other operational 

mechanism of the ESLI should be included.

3.15 Service Life Plan for a CBRN Air-Purifying Escape Respirator (APER)

Include a service life plan which contains information on reliability engineering methodology. In 

addition, appropriate service life dates, that users may rely upon for determining safe and 

reliable performance of the respirator under intended use conditions, should be included. The 

service life plan is a separate document from the User Instructions. Technical details for 

consideration must include: 

• Storage life of the various components based on intended use and environment. 

• Chemical and physical component deterioration over time. 

• The useful life of elastomers including facepiece, O-rings, breathing tubes, and seals. 

• Packaging design specs to eliminate deformation and enhance timely deployment. 

• Carrying characteristics which include expected daily shock and vibration assault. 

• Life expectancies of chemical adsorbents and filter media with expected moisture 

effects and degeneration over time. 
3/12/2018 49 APR and CBRN APR 

• Inspection procedures which address daily and periodic validation of condition to assure 

acceptability for emergency use. 

• Specific shelf, deployment, or carrying life as applicable and interdependency. 

• Intrinsic safety characteristics, if applicable. 

• Acceptable end user maintenance versus return to approval holder for service. 

• Allowable conditions of use including applicable regulations governing use. 

• Other characteristics to the specific CBRN APER design required to determine the 

weakest links and expected acceptable performance over the approved service life of 

the unit. 

• Description of how units will be date marked to clearly identify when the unit is to be 

removed from service. The date used can be the manufacturing date, deployment date, 

or terminal end-of-service-life date.

The service life plan must be based upon, and include, solid reliability engineering data that 

clearly shows component parts are good for the requested service life. This data can be 

manufacturer data, accelerated aging test data, literature review data, or data derived from 

actual field experience with similar components of the same material. An example would be a 

breathing tube of similar design and the same material used on another respirator under 

similar expected conditions.

Service life plans may be a composite of a text document, a spreadsheet, and a database file 

with drawings inserted or attached. Where composite documents are produced, NIOSH prefers 

that all parts be merged into a single document in a NIOSH-compatible format of the approval 

holder’s choice.

When the service life plan changes, clearly delineate what has changed in the document by 

either bolding or underlining text changes when the updated draft is submitted for approval.

Note: The service life plan is not to be confused with the air-purifying cartridge service life 

which indicates the length of time required for an air-purifying element to reach a specific 

effluent concentration or the time for which adequate breathing gas is supplied.

3.16 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.
3/12/2018 50 APR and CBRN APR 

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

Gas Mask Entire Mask container and canister.

Supplied-Air Respirator Entire Respirator container or instruction card.

Particulate Respirator

 

Entire Respirator container and filter container.

Abbreviated Filters.

Chemical-Cartridge 

Respirator

 

Entire Respirator container, cartridge container, and filter 

containers (where applicable).

Abbreviated Cartridges, filters, and filter containers.

When a company receives and accepts a NIOSH approval, the company agrees to manufacture, 

inspect, and test the respirator as it stated in the documentation as approved by NIOSH. The 

company will maintain the PQP, as submitted and approved, and will not deviate from this plan. 

The plan will only be changed after the company submits a request to NIOSH and this plan 

change is reviewed and approved by NIOSH. 

Each respirator, respirator component, and respirator container will, as required by NIOSH to 

assure quality control and proper use of the respirator, be labeled distinctly to show the name 

of the applicant, and the name and letters or numbers by which the respirator or respirator 

component is designated for trade purposes, and the lot number, serial number, or 

approximate date of manufacture.

NIOSH-Approved Air-Purifying Respirators advertised and marketed as “Surgical Masks” and 

used in the healthcare industry cannot indicate medical claims. NIOSH does not approve 

surgical masks. 

Approval holders may not imply “use” for approved respirators. 

Package advertising that is not permitted includes phrases such as:

“NIOSH-Approved Paint Spray Respirator.” 

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

Packaging may include a phrase such as: “NIOSH-Approved P100 respirator; recommended by 

the approval holder for lacquer paints.” 

3.17 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 
3/12/2018 51 APR and CBRN APR 

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. 

.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 filenaming conventions. Any files created in a language other than English will be returned 

unprocessed.
3/12/2018 52 APR and CBRN APR 

3.18 File Naming Conventions

Required Documents Naming Convention 

Abbreviation

Acceptable Software 

Packages File Naming Convention Format

Application Form - 

Adobe Acrobat

Microsoft Access

Java

XXXnnnn.PDF

XXXnnnn.MDB

XXXnnnn.xml

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.XLSnnnnDLb.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

Service Life Plan SLP followed by revision 

level (if applicable)

Adobe Acrobat

Scanned file

Excel

Microsoft Word

nnnnSLP.PDF

nnnnSLP.TIF

nnnnSLP.JPG

nnnnSLP.BMP

nnnnSLP.PNG

nnnnSLP.XLS

nnnnSLP.XLSX

nnnnSLP.DOC

nnnnSLP.DOCX

User Instructions UI followed by revision 

level (if applicable)

Adobe Acrobat

Scanned file

Microsoft Word

nnnnUIa.PDF

nnnnUIb.TIF

nnnnUIc.DOC

nnnnUId.DOCX

(a-d indicate various revision levels)
3/12/2018 53 APR and CBRN APR 

• If “zipped” files are submitted, provide the individual filename, description, and 

program for each working file contained in the zipped file.

• If there is more than one User Instructions or assembly matrix, list each in the assembly 

matrix by name.

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

the original files.

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

directly to the NIOSH employee requesting the files. The requestor is responsible for 

having the corrected files posted to the project. 

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

• NIOSH will only accept single documents under a single filename. Multiple documents 

under a single filename will not be accepted and the application may be denied.
3/12/2018 54 APR and CBRN APR 

Section 4 Approvals and Denials

4.1 Approval Documentation

If the respirator complies with all of the requirements outlined in these procedures and 42 CFR 

Part 84, NIOSH will grant an approval and assign a TC number. 

All submitted documentation and supporting test data will become part of the approval record. 

NIOSH will send a letter to the applicant’s primary contact stating the nature of the approval 

and will return final approval label files, if applicable, with the appropriate approval 

documentation. Applicants may use consultants or authorized representatives as contacts for 

the application. These contacts may submit applications either by request of the company’s 

primary contact or in place of the company’s 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’s 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, CD-Rs or DVD-Rs, and all sample hardware will be returned to the 

applicant’s U.S. or Canadian address or authorized representative. It is recommended that 

foreign applicants have and use their U.S. representative’s address on return shipping labels.

Note: If any failure occurs in a series of applications, all related applications will also be denied. 

Subsequent requests for approval of previously failed units must be submitted with all 

associated documentation and the reason for failure must be addressed.

4.3 Denial Prior to Assignment of a Task Number

Some of the reasons applications will not be accepted and will be denied prior to issuance of a 

TN include: 

• An application is assigned a previously used AAR#. 
3/12/2018 55 APR and CBRN APR 

• A major section of the application such as the assembly matrix, QA Manual, approval 

labels, pretest data, User Instructions, or drawing package is missing, is in an 

unacceptable file format, or uses an unacceptable file naming convention.

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

of one another.

• 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).

• The respirator is for underground mine use and has electrical components, but has not 

received MSHA intrinsic safety approval or the MSHA approval document has not been 

included with the application.

• 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, 

combination Air-Purifying/Supplied-Air Respirators 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 submission either (1) requested approval of two respirators of different 

basic designs (includes submitting a filter media and alternate 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.
3/12/2018 56 APR and CBRN APR 

• Protection or intended use claims have not been requested or approval has not been 

obtained from other governing agencies (such as FDA for surgical masks or medical 

claims).

• QA documentation does not have sufficient inspections identified, is missing required 

inspection steps, or inspections identified are not sufficient to meet the NIOSH 

requirements.

• The Quality Assurance Application includes other documents, such as a PQP or 

inspection procedures, in addition to or instead of the Quality Assurance Manual.

4.5 Respirator Certification (Approval) Program Decision Review 

 Process 

NIOSH NPPTL has a structured Decision Review Process that enables applicants to request a 

review of decisions regarding NIOSH NPPTL policy statements, test procedures, and test results 

pertaining to ongoing respirator certification activities.
3/12/2018 57 APR and CBRN APR 

Section 5 Respirator Tests for an Air-Purifying Respirator 

 or a CBRN Air-Purifying Respirator

Item Respirator Type *NIOSH Test # Title Total Materials Needed

1 Chemical cartridge,

 Subpart L 

 

 Nonpowered

Note: Adequate O2

necessary and 

concentration 

limitations. 

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

 3 complete respirator 

assemblies with components for 

assembling the highest and

lowest resistance combinations. 

 3 exhalation valve assemblies. 

 3 sets OV cartridges.

 10 sets of cartridges for each 

gas or vapor. 

Note: All combinations with an 

ESLI must be submitted to verify 

ESLI visibility and damage 

resistance.

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered AirPurifying Respirators with 

Gas Mask Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of aChloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life
3/12/2018 58 APR and CBRN APR 

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, 

Air-Purifying Respirators

with Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges
3/12/2018 59 APR and CBRN APR 

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered AirPurifying Respirators with 

Gas Mask Canisters

RCT-APR-STP-0050

Determination of OChlorobenzylidene

Malononitrile (CS) Service 

Life

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

RCT-APR-STP-0066 Determination of End-ofService-Life Indicator (ESLI)

 NOTE: ESLI tested where used.

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

2 Chemical cartridge 

with particulate 

filter

 Nonpowered

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

3 complete respirator 

assemblies with components for 

assembling the highest and

lowest resistance combinations. 

 3 exhalation valve assemblies. 

 3 sets OV cartridges. 

26 cartridges with filters for 

each particulate class of filter. 

+10 sets of cartridges with 

filters for each gas or vapor. 

Note: All combinations with an 

ESLI must be submitted to verify 

ESLI visibility and damage 

resistance.

 

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered AirPurifying Respirators with 

Gas Mask Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of aChloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges
3/12/2018 60 APR and CBRN APR 

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges
3/12/2018 61 APR and CBRN APR 

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered Air-

Purifying Respirators with 

Gas Mask Canisters

RCT-APR-STP-0050

Determination of 

O-Chlorobenzylidene 

Malononitrile (CS) Service 

Life

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0052

Determination of Particulate 

Filter Efficiency Level for P99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0053

Determination of Particulate 

Filter Efficiency Level for P95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0054

Determination of Particulate 

Filter Efficiency Level for 

R100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0055

Determination of Particulate 

Filter Efficiency Level for R99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0056

Determination of Particulate 

Filter Efficiency Level for R95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators
3/12/2018 62 APR and CBRN APR 

TEB-APR-STP-0057

Determination of Particulate 

Filter Efficiency Level for 

N100 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0058

Determination of Particulate 

Filter Efficiency Level for 

N99 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0059

Determination of Particulate 

Filter Efficiency Level for 

N95 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

RCT-APR-STP-0066 Determination of End-ofService-Life Indicator (ESLI)

Note: ESLI tested where used.

 * Actual tests selected may vary depending on design 

and intended use. 

Item Respirator Type *NIOSH Test # Title Total Materials Needed

3 Gas masks, 

 Subpart I

 Nonpowered

Note: Entry into 

non-IDLH with 

sufficient O2 and

escape.

May need ESLI for 

entry. 

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

3 complete respirator 

assemblies with components 

for assembling the highest and

lowest resistance 

combinations. 

 3 exhalation valve assemblies. 

 3 set OV canisters. 

10 sets of canisters for each gas 

or vapor. 

Note: All combinations with an 

ESLI must be submitted to verify 

ESLI visibility and damage 

resistance.

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

RCT-APR-STP-0014

Determination of Leakage of 

Drinking Tube and 

Accessories for Respirator 

Facepieces

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered AirPurifying Respirators with 

Gas Mask Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life
3/12/2018 63 APR and CBRN APR 

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of 

a-Chloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges
3/12/2018 64 APR and CBRN APR 

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, 

Air-Purifying Respirators

with Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered AirPurifying Respirators with 

Gas Mask Canisters

RCT-APR-STP-0050

Determination of

O-Chlorobenzylidene 

Malononitrile(CS)Service Life

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

RCT-APR-STP-0066 Determination of End-ofService-Life Indicator (ESLI)

 Note: ESLI tested where used.

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

4 Gas masks with 

particulate filters

 Nonpowered

Note: Entry into 

non-IDLH with 

sufficient O2 and

escape. 

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

3 complete respirator 

assemblies with components 

for assembling the highest and

lowest resistance 

combinations. 

 3 exhalation valve assemblies.

 3 set OV cartridges.

26 canisters with filters for each 

filter + 10 sets of canisters with 

filters for each additional gas or 

vapor. 

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

RCT-APR-STP-0014

Determination of Leakage of 

Drinking Tube and 

Accessories for Respirator 

Facepiecess
3/12/2018 65 APR and CBRN APR 

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

Note: All combinations with an 

ESLI must be submitted to verify 

ESLI visibility and damage 

resistance.

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered Air-Purifying 

Respirators with Gas Mask 

Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of aChloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges
3/12/2018 66 APR and CBRN APR 

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered Air-

Purifying Respirators with 

Gas Mask Canisters

RCT-APR-STP-0050

Determination of O-Chlorobenzylidene 

Malononitrile (CS) Service 

Life

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators
3/12/2018 67 APR and CBRN APR 

TEB-APR-STP-0052

Determination of Particulate 

Filter Efficiency Level for P99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0053

Determination of Particulate 

Filter Efficiency Level for P95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0054

Determination of Particulate 

Filter Efficiency Level for 

R100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0055

Determination of Particulate 

Filter Efficiency Level for R99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0056

Determination of Particulate 

Filter Efficiency Level for R95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0057

Determination of Particulate 

Filter Efficiency Level for 

N100 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0058

Determination of Particulate 

Filter Efficiency Level for 

N99 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0059

Determination of Particulate 

Filter Efficiency Level for 

N95 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

RCT-APR-STP-0066 Determination of End-ofService-Life Indicator (ESLI)

Note: ESLI tested where used.

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed
3/12/2018 68 APR and CBRN APR 

14 SA Type C-CE,

 demand

 Subpart J

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

2 complete units plus one each 

of all accessories.

All combinations of the 

maximum length of hose made 

up from the minimum hose 

lengths.

plus

All necessary quick disconnects

2 additional 25 foot lengths of 

airline hose.

RCT-ASR-STP-0100

Determination of Strength 

of Hoses and Couplings -

Type C and CE Supplied-Air 

Respirators

RCT-ASR-STP-0101

Determination of Tightness 

of Hoses and Couplings -

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0102

Determination of 

Nonkinkability of Hoses -

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0104

Determination of AirRegulating Valve 100,000 

Cycles Performance -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0105A

Determination of Airflow -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0108

Determination of Inhalation 

Airflow Resistance -

Demand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0109

Determination of Exhalation 

Airflow Resistance -

Demand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0110

Determination of 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 the following: 

RCT-ASR-STP-0112

Determination of the Level 

of Protection Provided by 

Abrasive Blast, Type CE, 

Supplied-Air Respirators 

Using a Challenge Aerosol of 

NaCl (Sodium Chloride) or 

Corn Oil

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

15 SA Type C-CE,

 pressure-demand TEB-APR-STP-0004 Determination of Exhalation Valve Leakage

2 complete units plus one each 

of all accessories.

All combinations of the 

maximum length of hose made 

up from the minimum hose 

lengths.

plus

RCT-ASR-STP-0100

Determination of Strength 

of Hoses and Couplings -

Type C and CE Supplied-Air 

Respirators

RCT-ASR-STP-0101

Determination of Tightness 

of Hoses and Couplings -

Type C and CE, Supplied-Air 

Respirators
3/12/2018 69 APR and CBRN APR 

RCT-ASR-STP-0102

Determination of 

Nonkinkability of Hoses -

Type C and CE, Supplied-Air 

Respirators

All necessary quick disconnects

2 additional 25 foot lengths of 

airline hose.

RCT-ASR-STP-0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0104

Determination of AirRegulating Valve 100,000 

Cycles Performance -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0105A

Determination of Airflow -

Demand and PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0106

Determination of Inhalation 

Airflow Resistance -

Pressure-Demand, Type C 

and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0107

Determination of Exhalation 

Airflow Resistance -

Pressure-Demand, Type C 

and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0110

Determination of 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 the following: 

RCT-ASR-STP-0112

Determination of the Level 

of Protection Provided by 

Abrasive Blast, Type CE, 

Supplied-Air Respirators 

Using a Challenge Aerosol of 

NaCl (Sodium Chloride) or 

Corn Oil

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

16 SA Type C-CE,

 constant flow TEB-APR-STP-0004 Determination of Exhalation Valve Leakage

2 complete units plus one each 

of all accessories.

All combinations of the 

maximum length of hose made 

up from the minimum hose 

lengths.

plus

All necessary quick-disconnects

2 additional 25 foot lengths of 

airline hose.

RCT-ASR-STP-0100

Determination of Strength 

of Hoses and Couplings -

Type C and CE Supplied-Air 

Respirators

RCT-ASR-STP-0101

Determination of Tightness 

of Hoses and Couplings -

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0102

Determination of 

Nonkinkability of Hoses -

Type C and CE, Supplied-Air 

Respirators

RCT-ASR-STP-0103

Determination of Gasoline 

Permeation of Hoses and 

Couplings - Type C, and CE, 

Supplied-Air Respirators
3/12/2018 70 APR and CBRN APR 

RCT-ASR-STP-0105

Determination of Airflow -

Continuous Flow, Type C and 

CE, Supplied-Air Respirators

RCT-ASR-STP-0110

Determination of GasTightness Test - Isoamyl 

Acetate, (IAA) - Type C, and 

CE, Supplied-Air Respirators

RCT-ASR-STP-0111

Determination of Air 

Velocity and Noise Levels -

Sound Level, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0113

Determination of Airflow 

Resistance - ContinuousFlow, Type C and CE, 

Supplied-Air Respirators

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

respirators, perform all above tests plus

RCT-ASR-STP-0112

Determination of the Level 

of Protection Provided by 

Abrasive Blast, Type CE, 

Supplied-Air Respirators 

Using a Challenge Aerosol of 

NaCl (Sodium Chloride) or 

Corn Oil

* Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

17 Vinyl chloride 

special use 

Subpart N

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

3 complete respirator 

assemblies with components for 

assembling the highest and

lowest resistance combinations.

3 exhalation valve assemblies. 

3 sets OV cartridges.

26 cartridges with filters for 

each particulate class of filter.

+ 10 sets of cartridges with 

filters for each gas or vapor.

Note: All combinations with an 

ESLI must be submitted to verify 

ESLI visibility and damage 

resistance.

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered Air-Purifying 

Respirators with Gas Mask 

Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of aChloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life
3/12/2018 71 APR and CBRN APR 

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges
3/12/2018 72 APR and CBRN APR 

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered Air-

Purifying Respirators with 

Gas Mask Canisters

RCT-APR-STP-0050

Determination of O-Chlorobenzylidene 

Malononitrile (CS) Service 

Life

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0052

Determination of Particulate 

Filter Efficiency Level for P99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0053

Determination of Particulate 

Filter Efficiency Level for P95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0054

Determination of Particulate 

Filter Efficiency Level for 

R100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0055

Determination of Particulate 

Filter Efficiency Level for R99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0056

Determination of Particulate 

Filter Efficiency Level for R95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators
3/12/2018 73 APR and CBRN APR 

TEB-APR-STP-0057

Determination of Particulate 

Filter Efficiency Level for 

N100 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0058

Determination of Particulate 

Filter Efficiency Level for 

N99 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0059

Determination of Particulate 

Filter Efficiency Level for 

N95 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

RCT-APR-STP-0066 Determination of End-ofService-Life Indicator (ESLI)

Note: ESLI tested where used.

 * 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 the following:

All samples for each category as 

appropriate.

For combination SCBA/SAR:

RCT-ASR-STP-0119 

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-STP-0147 

Determination of Mode 

Transfer Test - Combination, 

Open-Circuit, Self-Contained 

Breathing Apparatus and 

Supplied-Air Respirators 

(SCBA/SAR)

For Combination SAR/AP:

RCT-APR-STP-0014

Determination of Leakage of 

Drinking Tube and 

Accessories for Respirator 

Facepieces

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

19 Filter Self-Rescuer

TEB-APR-STP-0003 Determination of Exhalation 

Resistance

20 complete respirator 

assemblies.

3 exhalation valve assemblies. TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage
3/12/2018 74 APR and CBRN APR 

TEB-APR-STP-0005, 

0005a, and 0006

Determination of Qualitative 

Isoamyl Acetate (IAA) 

Facepiece Fit Test

Note: All combinations with an 

ESLI must be submitted to 

verify ESLI visibility and damage 

TEB-APR-STP-0007 resistance. Determination of Inhalation 

Resistance

TEB-APR-STP-0033A

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0033B

Determination of Ammonia 

Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0033C

Determination of Ammonia 

Service Life Test, Powered 

Air-Purifying Respirators

with Cartridges

TEB-APR-STP-0033D

Determination of Ammonia 

Service Life Test, TightFitting Powered Air-Purifying 

Respirators with Gas Mask 

Canister(s)

RCT-APR-STP-0034 Carbon Monoxide Service 

Life

RCT-APR-STP-0035 Determination of Chlorine 

Service Life

RCT-APR-STP-0036 Determination of Chlorine 

Dioxide Service Life

RCT-APR-STP-0037

Determination of aChloroacetophenone (CN) 

Service Life

RCT-APR-STP-0038 Determination of Ethylene 

Oxide Service Life

TEB-APR-STP-0039A

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0039B

Determination of 

Formaldehyde Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0039C

Determination of 

Formaldehyde Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0040 Determination of Hydrogen 

Chloride Service Life

RCT-APR-STP-0041 Determination of Hydrogen 

Cyanide Service Life

RCT-APR-STP-0042 Determination of Hydrogen 

Fluoride Service Life

TEB-APR-STP-0043A

Determination of Hydrogen 

Sulfide Service Life Test, AirPurifying Respirators with 

Cartridges

TEB-APR-STP-0043B

Determination of Hydrogen 

Sulfide Service Life Test, AirPurifying Respirators with 

Canisters

TEB-APR-STP-0043C

Determination of Hydrogen 

Sulfide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

RCT-APR-STP-0044 Determination of Mercury 

Vapor Service Life
3/12/2018 75 APR and CBRN APR 

TEB-APR-STP-0045A

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045B

Determination of 

Methylamine Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0045C

Determination of 

Methylamine Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0045D

Determination of 

Methylamine Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

TEB-APR-STP-0046A

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046B

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Air-Purifying 

Respirators with Canisters

TEB-APR-STP-0046C

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0046D

Determination of Organic 

Vapor (Carbon 

Tetrachloride) Service Life

Test, Tight-Fitting Powered 

Air-Purifying Respirators

with Gas Mask Canister(s)

RCT-APR-STP-0047 Determination of Phosphine 

Service Life

TEB-APR-STP-0048A

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Cartridges

TEB-APR-STP-0048B

Determination of Sulfur 

Dioxide Service Life Test, Air-

Purifying Respirators with 

Canisters

TEB-APR-STP-0048C

Determination of Sulfur 

Dioxide Service Life Test, 

Powered Air-Purifying 

Respirators with Cartridges

TEB-APR-STP-0048D

Determination of Sulfur 

Dioxide Service Life Test, 

Tight-Fitting Powered Air-

Purifying Respirators with 

Gas Mask Canisters

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators
3/12/2018 76 APR and CBRN APR 

TEB-APR-STP-0052

Determination of Particulate 

Filter Efficiency Level for P99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0053

Determination of Particulate 

Filter Efficiency Level for P95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0054

Determination of Particulate 

Filter Efficiency Level for 

R100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0055

Determination of Particulate 

Filter Efficiency Level for R99 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0056

Determination of Particulate 

Filter Efficiency Level for R95 

Series Filters Against Liquid 

Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0057

Determination of Particulate 

Filter Efficiency Level for 

N100 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0058

Determination of Particulate 

Filter Efficiency Level for 

N99 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

TEB-APR-STP-0059

Determination of Particulate 

Filter Efficiency Level for 

N95 Series Filters Against 

Solid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0060 Determination of End-ofService-Life Indicator Drop

RCT-APR-STP-0061

Determination of End-ofService-Life Indicator 

Visibility

RCT-APR-STP-0062 Determination of Nitrogen 

Dioxide Service Life

Note: ESLI tested where used.

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

20 CBRN APRs TEB-APR-STP-0003 Determination of Exhalation 

Resistance

4 complete respirators for live 

agent testing qualification.

6 complete respirators for live 

TEB-APR-STP-0004 Determination of Exhalation agent testing remaining after

Valve Leakage
3/12/2018 77 APR and CBRN APR 

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

environmental conditioning.

125 canisters minimum.

48 complete respirators for 

bench testing minimum. RCT-APR-STP-0014

Determination of Leakage of 

Drinking Tube and 

Accessories for Respirator 

Facepieces

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0064

Determination of Facepiece 

Carbon Dioxide and Oxygen 

Concentration Levels - TightFitting, Powered AirPurifying Respirators, with 

the Blower Unit Off

CET-APRS-STP-CBRN0301

Determination of CBRN 

Organic Vapor (Cyclohexane) 

Service Life Test (set of 9 

canisters)

CET-APRS-STP-CBRN0302

Determination of CBRN Acid 

Gases (Cyanogen Chloride) 

Service Life Test (set of 9 

canisters)

CET-APRS-STP-CBRN0303

Determination of CBRN Acid 

Gases (Hydrogen Cyanide) 

Service Life Test (Set of 9 

Canisters)

CET-APRS-STP-CBRN0304

Determination of CBRN Acid 

Gases (Phosgene) Service 

Life Test (Set of 9 Canisters)

CET-APRS-STP-CBRN0305

Determination of CBRN Acid 

Gases (Hydrogen Sulfide) 

Service Life Test (Set of 9 

Canisters)

CET-APRS-STP-CBRN0306

Determination of CBRN Acid 

Gases (Sulfur Dioxide) 

Service Life Test (Set of 9 

Canisters)

CET-APRS-STP-CBRN0307

Determination of CBRN Acid 

Gases (Ammonia) Service 

Life Test (Set of 9 Canisters)

CET-APRS-STP-CBRN0308

Determination of CBRN 

Nitrogen Oxide Gases 

(Nitrogen Dioxide) Service 

Life Test (Set of 9 Canisters)

CET-APRS-STP-CBRN0309

Determination of CBRN 

Hydride Gases (Phosphine) 

Service Life Test (Set of 9 

Canisters)

CET-APRS-STP-CBRN0310

Determination of CBRN 

Formaldehyde Service Life 

Test, Air-Purifying 

Respirators (Set of 9 

Canisters)
3/12/2018 78 APR and CBRN APR 

CET-APRS-STP-CBRN0311

Laboratory Durability 

Conditioning Process for 

Environmental, 

Transportation and Rough 

Handling Use Conditions on 

Chemical, Biological, 

Radiological, and Nuclear 

(CBRN) Respiratory 

Protective Devices (RPDs) 

Standard Conditioning 

Procedure (SCP)

CET-APRS-STP-CBRN0312

Determination of Field of 

View for Full Facepiece 

Chemical, Biological,

Radiological, and Nuclear 

(CBRN) Respiratory 

Protective Devices (RPDs)

TEB-CBRN-APR-STP0313

Determination of 

Communication 

Performance Test for Speech 

Conveyance and 

Intelligibility of Chemical,

Biological, Radiological, and 

Nuclear (CBRN) Full

Facepiece Air-Purifying 

Respirator

CET-APRS-STP-CBRN0314

Determination of Lens 

Fogging on Full Facepiece 

Chemical, Biological,

Radiological, and Nuclear 

(CBRN) Air-Purifying 

Respirator

CET-APRS-STP-CBRN0316

Determination of Haze, 

Luminous-Transmittance, 

and Abrasion-Resistance 

Properties of the Primary 

Lens System Material For 

Full Facepiece Respiratory 

Protective Devices (RPDs)

RCT-CBRN-APR-STP0350

Determination of Full 

Facepiece, Tight-Fitting, 

Negative-Pressure, AirPurifying Respirator (APR) 

Performance During 

Dynamic Testing Against the 

Chemical Agent Vapor Sarin 

(GB)GB (SMARTMAN) 

Qualifier LAT (QLAT) only1 +

RCT-CBRN-APR-STP0350

Determination of Full 

Facepiece, Tight-Fitting, 

Negative-Pressure, AirPurifying Respirator (APR) 

Performance During 

Dynamic Testing Against the 

Chemical Agent Vapor Sarin 

(GB)GB (SMARTMAN) 

Remainder LAT (RLAT) 2 

trials +
3/12/2018 79 APR and CBRN APR 

RCT-CBRN-APR-STP0351

Determination of Full

Facepiece, Tight-Fitting, 

Negative Pressure, AirPurifying Respirator (APR) 

Performance During 

Dynamic Testing Against 

Chemical Agent Distilled 

Sulfur Mustard (HD) Vapor 

and Liquid CBRN

HD (SMARTMAN) QLAT 

only1 +

RCT-CBRN-APR-STP0351

Determination of Full

Facepiece, Tight-Fitting, 

Negative Pressure, AirPurifying Respirator (APR) 

Performance During 

Dynamic Testing Against 

Chemical Agent Distilled 

Sulfur Mustard (HD) Vapor 

And Liquid CBRN

HD (SMARTMAN) RLAT, 2 

trials +

TEB-CBRN-APR-STP0352

Determination of Laboratory 

Respirator Protection Level 

(LRPL) Values for CBRN SelfContained Breathing 

Apparatus (SCBA) 

Facepieces or CBRN AirPurifying Respirator (APR)

TEB-CBRN-APR-STP0353

Weight and Diameter

Draft test procedure in place, 

but final STP has not been 

published. Contact NIOSH

NPPTL for further information at 

412-386-4000.

+Tests performed at RDECOM.

 * Actual tests selected may vary depending on design 

and intended use.

Item Respirator Type *NIOSH Test # Title Total Materials Needed

22 CBRN APERs TEB-APR-STP-0003 Determination of Exhalation 

Resistance

4 complete respirator 

assemblies for live agent testing 

qualification.

6 complete respirator 

assemblies for live agent testing 

remaining after environmental 

conditioning.

234 complete respirator 

assemblies for bench testing 

minimum.

TEB-APR-STP-0004 Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0007 Determination of Inhalation 

Resistance

TEB-APR-STP-0051

Determination of Particulate 

Filter Efficiency Level for 

P100 Series Filters Against 

Liquid Particulates for 

Nonpowered, Air-Purifying 

Respirators

RCT-APR-STP-0064

Determination of Facepiece 

Carbon Dioxide and Oxygen 

Concentration Levels - TightFitting, Powered AirPurifying Respirators, with 

the Blower Unit Off

CET-APRS-STP-CBRN0312

Determination of Field of 

View for Full Facepiece 

Chemical, Biological,

Radiological, and Nuclear 

(CBRN) Respiratory 

Protective Devices (RPDs)
3/12/2018 80 APR and CBRN APR 

CET-APRS-STP-CBRN-

0401

Determination of CBRN 

Organic Vapor (Cyclohexane) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0402

Determination of CBRN Acid 

Gases (Cyanogen Chloride) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0403

Determination of CBRN Acid 

Gases (Hydrogen Cyanide) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0404

Determination of CBRN Acid 

Gases (Phosgene) Service 

Life Test, Air-Purifying 

Escape Respirators (Set of 9 

Canisters)

CET-APRS-STP-CBRN-

0405

Determination of CBRN Acid 

Gases (Hydrogen Sulfide) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0406

Determination of CBRN Acid 

Gases (Sulfur Dioxide) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0407

Determination of CBRN Base 

Gases (Ammonia) Service 

Life Test, Air-Purifying 

Escape Respirators (Set of 9 

Canisters)

CET-APRS-STP-CBRN-

0408

Determination of CBRN 

Nitrogen Oxide Gases 

(Nitrogen Dioxide) Service 

Life Test, Air-Purifying 

Escape Respirators (Set of 9 

Canisters)

CET-APRS-STP-CBRN-

0409

Determination of CBRN 

Hydride Gases (Phosphine) 

Service Life Test, Air-

Purifying Escape Respirators 

(Set of 9 Canisters)

CET-APRS-STP-CBRN-

0410

Determination of CBRN 

Formaldehyde Service Life 

Test, Air-Purifying Escape 

Respirators (Set of 9 

Canisters)

CET-APRS-STP-CBRN-

0411

Laboratory Durability 

Conditioning Process for 

Environmental, 

Transportation and Rough 

Handling Use Conditions on 

Chemical, Biological, 

Radiological, and Nuclear 

(CBRN)(Air-Purifying or Self-

Contained) Escape 

Respirator
3/12/2018 81 APR and CBRN APR 

CET-APRS-STP-CBRN0414

Fogging

Draft test procedure in place, 

but final STP has not been 

published. Contact NIOSH

NPPTL for more information at 

412-386-4000.

TEB-APR-STP-0417-

CBRN

Determination of 

Flammability and Heat 

Resistance, CBRN AirPurifying Escape Respirators

CET-APRS-STP-CBRN0450

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sarin 

(GB) Vapor of Chemical, 

Biological, Radiological, and 

Nuclear (CBRN) Air-Purifying 

Escape Respirator

GB (SMARTMAN) Qualifier 

LAT (QLAT) only 1 + 

CET-APRS-STP-CBRN0450

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sarin 

(GB) Vapor of Chemical, 

Biological, Radiological, and 

Nuclear (CBRN) Air-Purifying 

Escape RespiratorGB 

(SMARTMAN) remainder 

LAT (RLAT) 2 trials + 

CET-APRS-STP-CBRN0451

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sulfur 

Mustard (HD) Liquid And 

Vapor of The Chemical, 

Biological, Radiological, And 

Nuclear (CBRN) Air-Purifying 

Escape Respirator

HD (SMARTMAN) QLAT 

only1 +

CET-APRS-STP-CBRN0451

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sulfur 

Mustard (HD) Liquid And 

Vapor of The Chemical, 

Biological, Radiological, And 

Nuclear (CBRN) Air-Purifying 

Escape Respirator

HD (SMARTMAN) RLAT 2 

trials +

TEB-CBRN-APR-STP0452

Determination of Laboratory 

Respirator Protection Level 

(LRPL) Values for CBRN AirPurifying Escape Respirator 

(APER)

CET-APRS-STP-CBRN0454

Determination of Human 

Subject Breathing Gas 

(HSBG) Concentrations 

(Carbon Dioxide and 

Oxygen) for Chemical, 

Biological, Radiological, and 

Nuclear (CBRN) Air-Purifying 

Escape Respirator

+Tests performed at RDECOM.
3/12/2018 82 APR and CBRN APR 

 * Actual tests selected may vary depending on design 

and intended use.

26 Wildland Firefighter 

Respirator This is currently a draft.

Contact NIOSH NPPTL on 

testing required and number 

of samples.

 * Actual tests selected may vary depending on design 

and intended use.
3/12/2018 83 APR and CBRN APR 

Section 6 Air-Purifying Respirator and CBRN Air-Purifying 

 Respirator 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 applications to NIOSH. These checklists may not be allinclusive. 

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.

Test Samples (Hardware)

8. _____ Shipped under a separate cover.

9. _____ The individual test samples (hardware) for evaluation are identified with the 

AAR# and part numbers.

10. _____ The individual test samples (hardware) for evaluation are referenced on the 

assembly matrix. 

11. _____ The shipping container/box is marked with the associated AAR# and/or TN.

12. _____ The testing samples (hardware) package includes a packing slip identifying the 

item(s) and quantity(ies) shipped.

Fees

13. _____ The application fee check or electronic funds transfer (Pay.Gov) receipt for $200 

is included. 

14. _____ The fee check is dated less than 30 days before the submission date of the 

application.

15. _____ The check is payable to NIOSH.

16. _____ The check includes the EIN, if a U.S. company or subsidiary. 

17. _____ The check includes the AAR#. 
3/12/2018 84 APR and CBRN APR 

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, 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 Air-Purifying 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 drawings. 

29. _____ All the part numbers on the approval labels match the part numbers listed in the 

assembly matrix.

Cautions and Limitations

30. _____ All appropriate cautions and limitations statements are identified on the 

individual approvals.

31. _____ All cautions and limitations statements referred to on the approvals are stated 

on the label(s).

User Instructions
3/12/2018 85 APR and CBRN APR 

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. 
3/12/2018 86 APR and CBRN APR 

6.2 Exploded-View Drawing Checklist for an Air-Purifying Respirator 

 or a CBRN Air-Purifying Respirator

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

assembly matrix (except the User Instructions and service life plan).

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 explodedview 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. 
3/12/2018 87 APR and CBRN APR 

6.3 All Major Subassemblies Checklist for an Air-Purifying Respirator

 or a CBRN Air-Purifying Respirator

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.
3/12/2018 88 APR and CBRN APR 

 

6.4 Supplied-Air Respirator, Also Applicable for Combination 

 APR/SAR Applications

Respiratory Inlet Covering (Facepiece/Hood/Helmet)

1. _____ Lens has a statement on impact resistance GGG-M-125d, Oct. 11, 1965 

(amended July 30, 1969). Does not apply to types B, BE, C, and CE.

Air Supply Valve/Orifice/Demand or Pressure-Demand Regulator

1. _____ Parts list is required showing all parts that make up the air supply 

valve/orifice/regulator.

Hose/Couplings

1. _____ Couplings must be specified by both type and manufacturer, even if the type is a 

manufacturer name (for example: Foster-Schrader, 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 the hose.

Breathing Tube

1. _____ Inspection procedures or classification of defects include a method for checking 

the clamps on the breathing tube.
3/12/2018 89 APR and CBRN APR 

6.5 Negative Pressure Checklist for an Air-Purifying Respirator or 

 a CBRN Air-Purifying Respirator

Respiratory Inlet Covering - Except Filtering Facepiece (Mouthbit, Half-Mask, Full Facepiece, 

Tight-Fitting Hood or Helmet)

1. _____ Elasticity or tensile strength, as appropriate, length, and method of attachment 

of straps is listed. 

Filter - Except Filtering Facepiece

1. _____ Material specifications is listed. 

2. _____ Filtering mechanism for filter media is listed. 

3. _____ Lot number location and code, or date of manufacture, is listed. 

4. _____ Filter efficiency (N95, N99, N100, etc.) includes nuisance protections.

5. _____ Color and markings conform to either ANSI K13.1-1973 or ANSI Z88.7-2001, 

 and the applicable specification is listed. 

6. _____ Final filter media form (pleated, flat, etc.) is listed. 

7. _____ Vendor for filter material, if the filter material specification is not 

 determined by the respirator manufacturer is listed. 

8. _____ Filters containing carbon layers state that carbon is chromium free.

Cartridge or Canister

1. _____ Material specifications, including each carbon, with fill volume and mesh is 

 listed. 

2. _____ Statement declaring that the carbon is chromium free.

3. _____ Lot number location and code, or date of manufacture is listed. 

4. _____ Vendor for carbon material, if the carbon specification is not determined by the 

 respirator manufacturer is listed. 

5. _____ Location and material of end-of-service-life indicator (ESLI) is listed. 

6. _____ Color and markings conform to either ANSI K13.1-1973 or ANSI Z88.7-2001, 

 and the applicable specification. 

7. _____ Protections match those found in the SAF.
3/12/2018 90 APR and CBRN APR 

6.6 Private Label Checklist for an Air-Purifying Respirator or a CBRN 

 Air-Purifying Respirator

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

 number is included. 

2. _____ If private label APR 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 Air-Purifying 

 Respirator model/part number.

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

A. _____ Abbreviated label must include the following items:

a. Private label company name. 

b. NIOSH is printed in block letters. 

c. Protection (N95, R95, P95, etc.). 

d. Model or part number. 

e. The lot or date code is included on label or packaging.

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 Air-Purifying Respirator has been manufactured 

 by approval holder xxx for private label company yyyy under TC- 

 84A-nnnn or TC-84A-CBRN-nnnn. 

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

 either in the application or on a separate sheet. 
3/12/2018 91 APR and CBRN APR 

6.7 Assembly Matrix Checklist for an Air-Purifying Respirator or a 

 CBRN Air-Purifying Respirator

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 Nuisance OV). 

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. 
3/12/2018 92 APR and CBRN APR 

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.
3/12/2018 93 APR and CBRN APR 

Section 7 - Document Examples for an Air-Purifying 

 Respirator or CBRN Air-Purifying Respirator

7.1 Example of a Product Quality Control Plan for an Air-Purifying 

 Respirator or a CBRN Air-Purifying Respirator 

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

DWFF Full Facepiece Air-Purifying 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/Resistance

Major A Assembly 

Station

100% TP-00LT

Valve Leak Test Major B Assembly 

Station

2.5% TP-00VL

2 Chemical 

Cartridge

(or 

Canister)

Assembly 

Correct

Major A Assembly 

Station

100% Visual Assembly 

Station

Service 

Life/Resistance 

Major A QA Test 

Lab

1% TP-00CC QA Test 

Lab

3 Filter (not 

for CBRN)

Assembly 

Correct

Major A Assembly 

Station

1% Visual Assembly 

Station

Efficiency Test Major A QA Test 

Lab

1% 

Destructive

TP-00FE QA Test 

Lab

Efficiency Check 

Test

Major A Assembly 

Station

100% TP00FCTAssembly 

Station

4 Accessories Assembly 

Correct

Minor Assembly 

Station

4% Visual Assembly 

Station
3/12/2018 94 APR and CBRN APR 

7.2 Example of a Full Facepiece Exploded-View Drawing for an Air-Purifying 

Respirator or a CBRN Air-Purifying Respirator

 
3/12/2018 95 APR and CBRN APR 

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

Supplied-Air and Air-Purifying Respirator
3/12/2018 96 APR and CBRN APR 

7.4 Example of an Assembly Matrix for a Combination Air-Purifying/Supplied-Air 

Respirator

(G)

(H)

Compon

ent

Alternate 

Retainer

Accessory

A B C D A A A B B B C D A B A B A B A B A B C A B C

Descript

ion

Full Facepiece-SmallFull Facepiece-MediumFull Facepiece-LargePlugHolderFullface AdapterAdapterOrganic VaporChlorineOV/CL/HC/SDOrganic VaporChlorineOV/CL/HC/SDAmmonia/MethylamineFormaldehyde/P100N95N100R99P100RetainerAirline AdapterAirline AdapterBreathing TubeBreathing TubeARVHigh Pressure ConnectorLow Pressure ConnectorHigh Pressure HoseHigh Pressure Hose-YellowLow Pressure HosePrefilter with Retainer

Revision D

RDCCAC

E

G

F

BBCBB

F

AAA

F

DDADG

E

BKA

F

B

Drawing 

Number

8614129586166441123279013445111411151116852385248525852685278702870087018636449412781278644525171217326732685637772213761118

Part 

Number

8618-41295-68616-86441-71232-97901-03445-31114-91115-61116-48523-68524-48525-18526-98527-78700-58700-08701-98636-64494-81278-21278-56445-82517-31217-03267-13268-95637-77722-01376-41118-0

AAR#

(C) 

NIOSH 

Approval 

Number, 

TC-

(D)

Protec

tion

(E) Model 

Number

2001SM

2001

2001L

20001999

701502

199819891952

61626364

65C

2001F102001F112001F12

20

2001728720013187200110102001318820013188200130622001319420013195

200135-25200035-25200020-25

7255

19C-199 DE/SA X X X X X X X X X X

19C-238 PD/SA X X X X X X X X X

19C-239 CF/SA X X X X X X X X X X

23C-690

OV/CL

/HC/

SD

X X X X X X X A

23C-692

AM/

MA X X X X X X A

23C-693

OV/SA

/DE X X X X X X X X X X X X X X X

23C-694

CL/SA/

CF X X X X X X X X X X X X

84A1695FM/

P100 X X X X X

M27

18a

84AM2718a N95 P P P P P P

84A1610R100/

SA/PD X X X X X X X X X X X X X

84A1210R99/

SA/DE X X X X X X X X X X X X X X Alternate Filters Alternate Airline 

Adapter

Alternate 

Breathing 

Tube

Alternate 

Regulator

Alternate 

Hoses/

Lengths

TN or AAR# of previously approved or pending Matrix: N/A

NA see exploded-view drawing for each respirator configuration

Exploded-view drawing: SK-10454

Double Wing Manufacturing Company

1234 Manufacture Lane

Pittsburgh, PA, USA

Phone: 412-555-1212 Alternate Facepiece Alternate Adapter

Alternate 

Cartridges

Key Box:

X= Currently Approved in this 

Configuration

N=New Component or 

Configuration

"-"=Obsolete

R=Redesign

P=Pending

A=Accessory

U=Upgrade/Retrofit

Revision: 1

Date: August 15, 2015
3/12/2018 97 APR and CBRN APR 

7.5 Example of an Assembly Matrix for a Half-Mask Air-Purifying Respirator

Key Box:

X= Currently Approved in this 

Configuration

N=New Component or Configuration

"-"=Obsolete

R=Redesign

P=Pending

A=Accessory

Double Wing Manufacturing Company

1234 Manufacture Lane

Pittsburgh, PA, USA

Phone: 412-555-1212

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

Date: August 1, 

2015 NA see exploded-view drawing for each respirator configuration

Revision: 1 (H) Exploded-view drawing: SK-10454

(A) Item 1 2 3 4 X

Com

pon

ent

Face

piece Alternate Filter Alternate Cartridge

Alternate Filter 

Retainer

User 

Instruct

ions

a b c a b c d e a b

Desc

ripti

on

HalfMaskN95

Filter

R95

Filter

R100

Filter

OV 

Cart

ridge

AM/

MA 

Cart

ridge

AG 

Cart

ridge

MV 

Cart

ridge

FM 

Cart

ridge

N and R 

Retainer

R100 

Retainer

User 

Instruct

ions

Revi

sion 1 0 0 0 1 2 2 2 1 1 1 0

Dra

wing 

Num

ber

FP

1000

FN95

-100

FR95

-100

FR100

-100

COV

100

CAM

100

CAG

100

CMV

100

CFM

100

RNR-2- 

100

RR100- 

100 N/A

AAR#

(C) 

NIOSH 

Approval 

Number, 

TC- 

(D)

Prote

ction

(E) 

Mod

el/

Part 

Num

ber

1000 HALO ARCH CRO

WN 1001 1002 1003 1004 1005 9435 9435 UI002

DWM

008

84A2000N95/C

L/MV X X X X N

DWM

009

84A2001

R95/

AM/

MA X X X X N

DWM

010

84AAARaR95/

OV N N N N N

DWM

010

84AAARbR100/

OV N N N N N

DWM

007

23C0100 FM X S X R

DWM

006

23C0101

CL/HC

/SD/

HS

(esc) X X R

NIOSH 

Referenc

e: Last 

Tested

NIOS

H TN (B)

TN

03993

TN

03993

TN

03993

TN

03733

TN

03733

TN

04237

TN

04237

TN

04237

TN

04237

TN

04237

TN

04237 N
3/12/2018 98 APR and CBRN APR 

7.6 Example of an Assembly Matrix for a CBRN Air-Purifying Respirator

(G)

(H)

(A) Item 3 5

Compon

ent Storage

User 

Instructions

ABCABCAABCA

Descript

ion

Model 61 Full Facepiece SmallModel 61 Full Facepiece MediumModel 61 Full Facepiece LargeCBRN CB1 Canister (Packaging)CBRN CB2 Canister (Packaging)CBRN CB3 Canister (Packaging)Respirator Storage BagSun Visor OutsertSpectical KitMicrophone ElectretDW CBRN APR User Instructions

Part 

Number

FP61-02FP61-01FP61-03CNCBRN01CNCBRN02CNCBRN03RSB01SOV01SK01MI01UI123

Revision 

Number

55533313213

AAR#

(C) 

NIOSH 

Approval 

Number, 

TC-

(D)

Protection

(E) 

Drawing 

Number M61FP M61FP M61FP CAN61 CAN61 CAN61 RSB61 SOV61 SK61 MI61 UI123

14G0123CBRN

CAP 1 X X X X X X X P X

DMW00314G0345CBRN

CAP 2 P P P P X P P P P

DWM004

14GDMW004

CBRN

CAP 3

N N N N N N N N N

(B)

15678 15678 15678 12345 N N 13456 14567 14567 14567 18901

NIOSH Task Number: Where 

component was last tested 

(if new, indicate "N")

Date: August 31, 2015

Respirator Component Approval Matrix

Facepieces Alternate Canisters Accessories

1 2 4

NA see exploded-view drawing for each respirator configuration

Key Box:

X= Currently Approved in this 

Configuration

N=New Component or Configuration

"-"=Obsolete

R=Redesign

P=Pending

A=Accessory

TN or AAR# of previously approved or pending Matrix: N/A

Revision: 2 Exploded-view drawing: SK-10454

Double Wing Manufacturing Company

1234 Manufacture Lane

Pittsburgh, PA, USA

Phone: 412-555-1212
3/12/2018 99 APR and CBRN APR 

7.7 Example of an Approval Label for a Half-Mask Air-Purifying Respirator

Double Wing Manufacturing Company

 Almost Heaven, West Virginia, USA 

1-800-123-4567

This respirator is approved only in the following configurations:

TC- Protection 1 Facepiece Alternate Filter Alternate Cartridge Alternate Filter 

Retainer

Cautions

and

Limitations 2

 1000 HA

LO

AR

CH

WI

NG

CRO

WN

10

01

10

02

10

03

10

04

10

05

94

35

94

35

94

35 

84AAARa N95/CL/MV X X X X X ABCHJLMNOPS

84AAARbR95/AM/

MA X X X X X ABCHJLMNOP

84AAARc R95/OV X X X X X ABCHJLMNOP

84AAARd P99/OV X X X X ABCHJLMNOP

84AAARe R100/OV X X X X ABCHJLMNOP

23CAARf FM X X ABCHJKLMNO

23CAARgCL/HC/SD/

HS(esc) X X ABCHJLMNO

1. PROTECTION

N95-Particulate Filter

(95% filter efficiency level) 

Effective against 

particulate aerosols free of 

oil; time use restrictions 

may apply.

R100-Particulate Filter

(99.97% filter efficiency 

level) Effective against all 

particulate aerosols; time 

use restrictions may apply.

P99-Particulate Filter

(99% filter efficiency level) 

Effective against all 

particulate aerosols.

R95-Particulate Filter (95% 

filter efficiency level) Effective 

against all particulate aerosols; 

time use restrictions may apply.

AM - Ammonia MA - Methylamine FM - Formaldehyde CL - Chlorine

OV - Organic Vapor MV - Mercury Vapor HC - Hydrogen Chloride 

SD - Sulfur Dioxide HS(esc) - Hydrogen Sulfide (Escape-Only) 

2. 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.

H Follow established cartridge and canister change schedules or observe ESLI to ensure 

that cartridges and canisters are replaced before breakthrough occurs.

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.
3/12/2018 100 APR and CBRN APR 

L Follow the manufacturer 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.

P NIOSH does not evaluate respirators for use as surgical masks.

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning.
3/12/2018 101 APR and CBRN APR 

7.8 Example of an Approval Label for a Full Facepiece CBRN Air-Purifying 

Respirator 

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

 This respirator is approved only in the following configurations:

TC- Protection 1

Facepiece 

in Storage 

Container

Alternate 

Canisters in 

Storage Container

Accessories

Cautions

and

Limitations 2/3

 1000 HALO ARCH 943

5

943

5

943

5 

14G-AARaCBRNCBRN CAP 

1 X X X X AJLMNOSTVWXYZ CC HH QQ UU

14G-AARbCBRN

CBRN CAP 

1 X X X X X AJLMNOSTVWXYZ CC HH QQ UU

1. PROTECTION

CBRN – Chemical, Biological, Radiological, and Nuclear. 

CAP 1 – Capacity meets minimum 15 minute test time.

2. CAUTIONS and LIMITATIONS 

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.

L Follow the manufacturer 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.

CC For entry, do not exceed maximum use concentrations established by regulatory 

standards.

 

3. CBRN CAUTIONS and LIMITATIONS

T Direct contact with CBRN agents requires proper handling of the respirator after 

each use and between multiple entries during the same use. Decontamination 

and disposal procedures must be followed. If contaminated with liquid chemical 

warfare agents, dispose of the respirator after decontamination.
3/12/2018 102 APR and CBRN APR 

V Not for use in atmospheres immediately dangerous to life or health or where 

hazards have not been fully characterized.

W Use replacement parts in the configuration as specified by the applicable 

regulations and guidance.

X Consult manufacturer’s User Instructions for information on the use,storage, and

maintenance of these respirators at varioustemperatures.

Y The respirator providesrespiratory protection against inhalation of radiological

and nuclear dust particles. Proceduresfor monitoring radiation exposure and full

radiation protection must be followed. 

Z If during use, an unexpected hazard is encountered such as a secondary CBRN

device, pockets of entrapped hazard or any unforeseen hazard, immediately

leave the area for clean air.

HH When used at defined occupational exposure limits, the rated service time cannot

be exceeded. Follow established canister change out schedules or observe End of

Service Life Indicatorsto ensure that canisters are replaced before breakthrough

occurs.

QQ Use in conjunction with personal protective ensemblesthat provide appropriate

levels of protection against dermal hazard. Failure to do so may result in

personal injury even when the respirator is properly fitted, used, and maintained.

UU The respirator should not be used beyond eight (8) hours after initial exposure to

chemical warfare agentsto avoid possibility of agent permeation. If liquid exposure

is encountered, the respirator should not be used for more than two (2) hours.
3/12/2018 103 APR and CBRN APR 

7.9 Example of an Approval Label for a Filter for an Air-Purifying Respirator 

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

Crown Filter

This filter is approved only in the following configurations:

1. PROTECTION

P100-Particulate Filter 

(99.97% filter efficiency level) 

Effective against all particulate 

aerosols.

 

AM - Ammonia CF - Continuous Flow FM - Formaldehyde

HC - Hydrogen Chloride HS - Hydrogen Sulfide MA - Methylamine 

PD - Pressure-Demand SA - Supplied-Air SD - Sulfur Dioxide 

OV - Organic Vapor ESC - Escape-Only CL - Chlorine 

 

2. 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.

Respirator Components

Protection Filter Alternate Facepiece Alternate Cartridge Alternate Hose

Alternate 

Regulator

Cautions 

and 

Limitations

Cro

wn

10

00

20

00

30

00

40

00

50

00

10

01

10

02

10

03

10

04

10

05

943

-25

943

-50

943

-100

30

21

30

22

30

25

P100 X X

ABCJL

MNOP

P100 X X

ABCJL

MNOP

P100/OV X X X X

ABCJH

LMNOP

P100/AM/ 

MA/SA/CF X X X X X X X X X

ABCDEGH

JLMNOPS

P100/FM/ 

SA/CF X X X X X X X X X

ABCDEGH

JKLMNOP

P100/CL/

HC/SD/ 

HS(esc)/

SA/PD X X X X X

ABCDEGH

JLMNOPS
3/12/2018 104 APR and CBRN APR 

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

G If airflow is cut off, switch to filter and/or cartridge or canister and immediately exit to 

clean air.

H Follow established cartridge and canister change schedules or observe ESLI to ensure 

that cartridges and canisters are replaced before breakthrough occurs.

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.

P NIOSH does not evaluate respirators for use as surgical masks. 

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning.
3/12/2018 105 APR and CBRN APR 

7.10 Example of an Approval Label for a Chemical Cartridge for an Air- 

 Purifying Respirator

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

1001 Cartridge

This cartridge is approved only in the following configurations: 

Respirator Components

TC- Protection

Cart

ridge Alternate Facepiece Alternate Filter

Alternate Hoses/

Lengths

Alternate 

Regulator

Cautions 

and 

Limitations

10

01

10

00

20

00

30

00

40

00

50

00

HA

LO

WI

ND

GA

TE

GLO

RY

CRO

WN

943

-25

943

-50

943

-100

30

21

30

22

30

25

23CAARa OV X XABCHJ

LMNO

84AAARb OV/N95 X X XABCHJ

MNOP

84AAARc OV/N100 X X X XABCHJ

LMNOP

84AAARdOV/R99 

/SA/CF X X X X X X X X X

ABCDEGH

JLMNOPS

84AAAReOV/P95/

SA/DE X X X X X X X

ABCDEGH

JLMNOPS

84AAARf OV/P100 X X X X XABCHJ

LMNOP

1. PROTECTION

N100-Particulate Filter 

(99.97% filter efficiency level) 

Effective against particulate 

aerosols free of oil; time use 

restrictions may apply.

R99-Particulate Filter (99% 

filter efficiency level) 

Effective against all 

particulate aerosols; time use 

restrictions may apply. 

P100-Particulate Filter 

(99.97% filter efficiency 

level) Effective against all 

particulate aerosols. 

N95-Particulate Filter (95% 

filter efficiency level) 

Effective against particulate 

aerosols free of oil; time use 

restrictions may apply. 

P95-Particulate Filter (95% 

filter efficiency level) 

Effective against all 

particulate aerosols. 

OV - Organic Vapor

DE - Demand

CF - Continuous Flow 

SA - Supplied Air 

2. 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.
3/12/2018 106 APR and CBRN APR 

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 Instructions.

G If airflow is cut off, switch to filter and/or cartridge or canister and immediately exit to 

clean air.

H Follow established cartridge and canister change schedules or observe ESLI to ensure 

that cartridges and canisters are replaced before breakthrough occurs.

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

L Follow the manufacturer 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.

P NIOSH does not evaluate respirators for use as surgical masks.

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning. 
3/12/2018 107 APR and CBRN APR 

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

 Cartridges and Filters

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: 

Respirator Components

TC- Protection Filter Alternate Facepiece Alternate Cartridge

Alternate 

Hoses/

Length

Alternate 

Regulator

Cautions 

and 

Limitations

CRO

WN

10

00

20

00

30

00

40

00

50

00

10

01

10

02

10

03

10

04

10

05

943

-25

943

-50

943

-100

30

21

30

22

30

25

84AAARa P100 X XABDJL

MNOP

84AAARb P100 X XABCJL

MNOP

84AAARc P100/OV X X X XABCJH

LMNOP

84AAARd

P100/AM/ 

MA/SA/

CF X X X X X X X X X

ABCDEGH

LMNOPS

84AAAReP100/FM/ 

SA/CF X X X X X X X X X

ABCDEGH

JKLMNOP

84AAARfP100/CD/ 

HC/SD X X X X X

ABCHJ

LMNOP

84AAARg

P100/HC/ 

SD/HS(esc)/

SA/PD X X X X X

ABCDEGH

LMNOPS

1. PROTECTION

 

AM - Ammonia CF - Continuous Flow CL - Chlorine 

FM - Formaldehyde HC - Hydrogen Chloride HS - Hydrogen Sulfide

MA - Methylamine OV - Organic Vapor PD - Pressure-Demand

SA - Supplied-Air SD - Sulfur Dioxide ESC - Escape-Only

2. CAUTIONS and LIMITATIONS

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

P100-Particulate Filter 

(99.7% filter efficiency 

level) Effective against all 

particulate aerosols.
3/12/2018 108 APR and CBRN APR 

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 Instructions.

G If airflow is cut off, switch to filter and/or cartridge or canister and immediately exit to 

clean air.

H Follow established cartridge and canister change schedules or observe ESLI to ensure 

that cartridges and canisters are replaced before breakthrough occurs.

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.

P NIOSH does not evaluate respirators for use as surgical masks. 

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning 
3/12/2018 109 APR and CBRN APR 

7.12 Example Label for an Abbreviated Filter for an Air-Purifying Respirator 

Filter Version

Note: 

The company name must be completely spelled out or in a NIOSH acceptable abbreviation.

Contact NIOSH for acceptability of abbreviation.

In addition:

• The part number must be shown.

• The protections provided by the filter must be accurately listed. 

• Multiple protection identifiers, as listed on the full filter label, are separated by a 

forward slash.

• A lot number or other production tracking identifier must be provided on the respirator 

or container.

• The word “NIOSH” must be shown in all capital letters.

• All information must be provided in a legible typeface readable by the user. 

• The P100 series of filters must be magenta in color.

Double Wing 

Manufacturing

P/N 987 P100

Lot #xxxxxxx

NIOSH
3/12/2018 110 APR and CBRN APR 

7.13 Example Label for an Abbreviated Cartridge for an Air-Purifying 

 Respirator 

DOUBLE WING MANUFACTURING

• P/N 9876

• NIOSH

• OV/CL/HC/SD

• LOT #4321A

Note: 

The company name must be completely spelled out.

In addition:

• The part number must be shown.

• The protections provided by the cartridge must be accurately listed with each protection 

identifier as shown on the cartridge label and separated by a forward slash.

• The word “NIOSH” must be portrayed in all capital letters.

• A lot number or other production tracking identifier must be provided.

• All information must be provided in a legible typeface readable by the user.

• Color codes of cartridges for gases and vapors must meet the requirements of ANSI 

K13.1-1973 or ANSI Z88.7-2001. The applicable specification will indicated on the 

cartridge drawing.
3/12/2018 111 APR and CBRN APR 

7.14 Example Label for a Gas Mask Canister for an Air-Purifying Respirator 

(Note: The full matrix label may also be used on the canister)

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

List Canister Part Number and Trade Name

List Protections

TC-14G-XXX

TC-14G-YYY

TC-14G-ZZZ

TC-14G-AAA

Refer to the approved User Instructions for the complete list of component parts making 

up the approved assembly.

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-7.1 Grade D or higher quality.

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

G If airflow is cut off, switch to filter and/or cartridge or canister and immediately exit to clean air.

H Follow established cartridge and canister change schedules or observe ESLI to ensure that 

cartridges and canisters are replaced before breakthrough occurs.

I Contains electrical parts which have not been evaluated as an ignition source in flammable or 

explosive atmospheres by MSHA/NIOSH.

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 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.

P NIOSH does not evaluate respirators for use as surgical masks.

S Special or critical User Instructions and/or specific use limitations apply. Refer to User 

Instructions before donning. 

Note: The labels for gas mask respirators and canisters must appear in their entirety in the User 

Instructions. 
3/12/2018 112 APR and CBRN APR 

7.15 Example Label for a CBRN Air-Purifying Respirator Canister

(Note: The full matrix label may also be used on the canister)

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

List Canister Part Number and Trade Name

List CBRN CAP Level

TC-14G-XXX

Refer to the approved User Instructions for the complete list of component parts making 

up the approved assembly.

CAUTIONS and LIMITATIONS 

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 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. 

T Direct contact with CBRN agents requires proper handling of the respirator after each 

use and between multiple entries during the same use. Decontamination and disposal 

procedures must be followed. If contaminated with liquid chemical warfare agents, 

dispose of the respirator after decontamination.

V Not for use in atmospheres immediately dangerous to life or health or where hazards 

have not been fully characterized.

W Use replacement parts in the configuration as specified by the applicable regulations 

and guidance.

X Consult manufacturer’s User Instructions for information on the use, storage, and 

maintenance of these respirators at various temperatures.

Y The respirator providesrespiratory protection against inhalation of radiological and

nuclear dust particles. Procedures for monitoring radiation exposure and full radiation

protection must be followed. 
3/12/2018 113 APR and CBRN APR 

Z If during use, an unexpected hazard is encountered such as a secondary CBRN device,

pockets of entrapped hazard or any unforeseen hazard, immediately leave the area for

clean air

CC For entry, do not exceed maximum use concentrations established by regulatory 

standards.

HH When used at defined occupational exposure limits, the rated service time cannot be

exceeded. Follow established canister change outschedules or observe End-of-ServiceLife Indicators to ensure that canisters are replaced before breakthrough occurs.

QQ Use in conjunction with personal protective ensemblesthat provide appropriate levels of

protection against dermal hazard. Failure to do so may result in personal injury even

when the respirator is properly fitted, used, and maintained.

UU The respiratorshould not be used beyond eight (8) hours after initial exposure to chemical

warfare agentsto avoid possibility of agent permeation. If liquid exposure is encountered,

the respirator should not be used for more than two (2) hours.

Note: The labels for gas mask respirators and canisters must appear in their entirety in the 

 User Instructions. 
3/12/2018 114 APR and CBRN APR 

Section 8 - Label Format Guidance • Labels for Air-Purifying Respirators and CBRN Air-Purifying 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 subassemblies 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 

footnoted at the bottom of the label. 

• The abbreviated label mounted on filters or cartridges, for Air-Purifying Respirators, 

must clearly indicate the approval holder’s name, product model or trade name, 

protections, part number and lot number. The entire label must appear in the User 

Instructions.

• Canister labels must clearly indicate the approval holder’s name, address, phone 

number, model/trade name, type of protection, TC number, appropriate cautions and 

limitations, reference to the User Instructions for the major subassembly and 

component information, and HHS and NIOSH logos. The entire canister for an AirPurifying Respirator (gas mask) label must appear in the User Instructions.

• On the abbreviated label mounted on the cartridge, filter, or cartridge/filter 

combination, indicate the approval holder’s name, filter series (if a filter is included), gas 

or vapor protection, part number, lot number, and the acronym “NIOSH.”

• The abbreviated label may list either the two letter codes for gases and vapors (see label 

examples) or the entire chemical name. However, the abbreviated label must not have a 

mix of codes and names. 

• 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 
3/12/2018 115 APR and CBRN APR 

component information, and the HHS and NIOSH logos on gas mask canister labels. The 

entire gas mask label must appear in the User Instructions.

• 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., negative pressure half-mask. 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.

• The statement “Time use restrictions may apply” refers to the potential limited filter life 

associated with degradation of the filter efficiency as the result of exposure to aerosols 

in the workplace. The service life is dependent upon the concentration, type of 

contaminant, and use conditions encountered in the workplace, and must be 

determined on a workplace basis. Specific recommendations have been published in A 

NIOSH Guide to the Selection and Use of Particulate Respirators Certified Under 42 CFR 

Part 84 - HHS (NIOSH) Publication No. 96-101. 

• NIOSH only tests against gases and vapors individually, therefore the applicant assumes 

the liability for use of the respirators in mixed atmospheres. NIOSH assumes that the 

gases and vapors listed in the protection column of the approval labels are used against 

only one of the listed gases or vapors. An applicant may demonstrate to NIOSH that 

sorbents are effective in exposures to mixed gas and vapor atmospheres or serial 

exposures to different atmospheres by providing data to NIOSH satisfying the six criteria 

for mixed gas and vapor atmospheres as listed in the September 24, 1981 Letter to all 

Manufacturers. When the data has been received, reviewed, and accepted by NIOSH, 

approval holders are permitted to state that they endorse the use of the cartridges in 

mixed gas and vapor atmospheres in the User Instructions or respirator literature. The 

approval holder may not state that NIOSH endorses the use of the respirators in mixed 

gas and vapor atmospheres. 

• The slash on the label in the protection column serves only as a divider between 

protections. 

• 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. 
3/12/2018 116 APR and CBRN APR 

APPENDIX
3/12/2018 117 APR and CBRN APR 

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 Part 84), specifically in §§ 84.41(b) 

through 84.41(i). Some applicants or approval holders have had difficulty 

understanding how to select and use a sampling procedure which meets the 

requirements. This letter is intended to explain the practical use of common 

standard procedures acceptable to NIOSH. 

This letter will not discuss statistical theory underlying acceptance sampling. If 

applicants or approval holders intend to use alternatives to the procedures described 

here, they must understand the concepts of acceptance sampling and process 

control. The use of more modern methods such as calculating process capability 

values (Cpk) or employing statistical process control (SPC) is encouraged where this is 

compatible with the approval holder’s operations and provides equivalent assurance 

of respirator performance. Justification to demonstrate the equivalence of these 

procedures must be provided in the application seeking approval. 

1. Selection of Sampling Procedures 

1.1 Sampling by Variables. The standard sampling procedure specified in 42 CFR Part 

84 is MIL-STD-414 [U.S. Department of Defense 1957]. This is a variable sampling 

plan, which means that the characteristic must be something that can be measured 

numerically on a continuous scale. Examples include the diameter of a hole in inches, 

the mass of a cartridge in grams, or the leakage of an exhalation valve in milliliters 

per minute. This procedure is only valid when the characteristic being measured has 

a statistically normal distribution over the population being sampled. The ANSI/ASQ 

Z1.9 standard [American National Standards Institute 2003b] is derived from MILSTD-414, and NIOSH considers it to be equivalent. 
3/12/2018 118 APR and CBRN APR 

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 (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.
3/12/2018 119 APR and CBRN APR 

• 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.

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 lotsize 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 is in the

“destructive” column. Approval of a level lower than the “normal” level is entirely at NIOSH’s

option and will only be granted if the rest of the inspection plan ensures adequate control

over product quality.

Defect Classification AQL1,2

Major A 1.0

Major B 2.5

Minor 4.0
3/12/2018 120 APR and CBRN APR 

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. Thisincludes 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.

4.2 Recordsto Support Reduced Inspection. To use reduced inspection, the approval

holder must maintain inspection recordsshowing that the conditions in the applicable

procedure are met. Such records must be available for review during NIOSH on-site

audits.

4.3 Cross-References. See MIL-STD-414 sections A8, B14, C14, D14; ANSI/ASQ Z1.9-2003

section A10; MIL-STD-105D section 8; MIL-STD-105E sections 4.6, 4.7, 4.8; ANSI/ASQ Z1.4-

2003 section 8; Squeglia C=0 pages 14, 16.

5. Lots or Batches

5.1 Definition of Lot. Each procedure listed in this letter requires that product be grouped

into inspection lots (the term “batch” means the same as “lot”). Each lot consists of product

which has been manufactured under essentially the same conditions in the same production

facility and at essentially the same time. For example, if a production line is shut down for a 

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
3/12/2018 121 APR and CBRN APR 

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 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 isthe

overwhelmingly popular choice.
3/12/2018 122 APR and CBRN APR 

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 requiresfewer samples, but more complex

computations. 

7.4 Form 1 vs. Form 2. The two forms are equivalent and either one may be selected. Form 2 

is recommended as it yields figures which must be calculated anyway to satisfy the switching

rules.

7.5 Cross-References. See MIL-STD-414 Introduction, section A6.2; ANSI/ASQ Z1.9-2003

Introduction,section A6.2.

8. Scope

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
3/12/2018 123 APR and CBRN APR 

additional inspections is not required to meet the requirements set forth in 42 CFR Part 84

and this letter. However, there must be a reasonable basis for selecting the sampling

plans used.

8.2 Limitation to Required Testing. In some cases, applicants may wish to list testing and

inspection in their quality control plans above that required by NIOSH for effective quality

control of respirator performance. Sampling done for these additional inspections is not

required to meet the requirements in 42 CFR Part 84 and this letter. Additional testing should

be identified clearly, such as with the notation “additional inspection,” on documents

submitted with the application to avoid delay and requests for clarification during processing.

Any such testing listed in the approved quality control plan must be conducted as required by

42 CFR Section 84.42(c).

9. Common Errors

9.1 Selection of Inadequate Inspection Levels. The minimum acceptable inspection level is

described in section 3.2 of this letter. If a product quality control plan does not specify

inspection levels, NIOSH assumes that the level in the “normal” column of the table will be

used. Use of lower levels without specific approval, whatever the reason, is a failure to

conform to NIOSH requirements and can result in revocation of approval under 42 CFR Section 

84.43(c).

9.2 Selection of Plan Based on Desired Sample Size. It is entirely improper to choose a 

desired sample size and work backwards to identify a proposed AQL and inspection level

which will yield this result. To do so reflects a fundamental misunderstanding of the basis

for sampling plans. The appropriate AQL and inspection level are stated in sections 2.2 and

3.2 of this letter.

9.3 Selection of Defect Classification Based on Desired AQL. As in 9.2, the defect classification

drives the selection of AQL, not the other way around. Each defect must be classified based

solely on the definitions in 42 CFR Section 84.41(d).

9.4 Modification of AQL or Inspection Level Based on Lot Size or Other Factors. The AQL and

inspection level are chosen by the criteria in sections 2.2 and 3.2 of this letter. Approval

holders are free to use higher inspection levels if greater discrimination is desired, or to use

lower (more stringent) AQLs if a smaller percent defective is desired. However, these should

not be modified based on lot size or inspection history, as provisions already exist to account

for those factors. Changing AQL values or inspection levels is likely to result in a statistically

invalid plan.

9.5 Inappropriate Use of Reduced Inspection. As described in section 4.1 of this letter,

reduced inspection is permitted only when all conditions of the relevant procedure are met.

When there are significant delays or changes in production processes, approval holders must
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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 pieces from 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.

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
3/12/2018 125 APR and CBRN APR 

Chief, Technical Evaluation Branch

National Personal Protective Technology Laboratory
3/12/2018 126 APR and CBRN APR 

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.
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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.

Page 2 -Letter to All Respirator Manufacturers

Subcontractor Relationship Responsibilities

The approval documentation on file atNIOSH must demonstrate thatthe following criteria

have been met for NIOSH 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 in many different ways. One

example ofthisinvolvement and influence can be exhibited by participating inthe

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 inthe

subcontractor's Material ReviewBoard.

- The approval holder's methods formaintaining active involvement and influence over

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

suitsthe individual situation and manufacturing complexity ofthe secured goods. This

plan or procedure must be formally submitted to NIOSH.

- The approval holder will maintain copies of subcontractor quality records that

demonstrate compliance with NIOSH performance requirements. It is important to

assure that, in the event of a broken relationship, both the Approval Holder and NIOSH

have continued access to those records.

- 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 howthe approval holder establishes andmaintains active

involvement and influence overthe subcontractor's quality system. Thisinformation

must be specifically indicated and documented aspart of a Quality Assurance
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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 ofsignificant changes, and on a periodic basis, per NIOSH requirements.

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

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

directshipment fromthe subcontractorto be acceptable undertheNIOSH Approval.

- 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
3/12/2018 129 APR and CBRN APR 

DEPARTMENT OF HEALTH & HUMAN SERVICE Public Health Service 

September 24, 1981

Centers for Disease Control 

and Prevention

National Institutefor

Occupational Safetyand

Health - NIOSH

944 Chestnut Ridge Road

Morgantown, WV 26505

To All Respirator Manufacturers

During the past several years NIOSH has had inquiries from both respirator manufacturer’s and general 

industry on the Institute’s ability to certify Air-Purifying Respirators for compounds not listed in the 

regulations. The first basic step in determining whether NIOSH will certify is to refer to the Respirator 

Decision logic and use the substance’s chemical and physical properties to determine whether an AirPurifying Respirator can be worn for protection against this substance.

30 CFR 11:11.90(1) (c) and 11.150 states that NIOSH can accept applications for approvals of gas masks and 

chemical cartridge respirators for protection against gases and vapors not specifically listed. Acceptance or 

rejection of these applications are made on the basis of the effects on the wearer’s health and safety. In 

accordance with this requirement and the general construction (11.61 (a)) and general test requirements 

(11.63 (c)) the Institute has compiled a list of requirements that they feel are essential in determining 

potential wear effects.

All applications for approval of respirators designed as respiratory protection against gases or vapors not 

specifically set forth in Part 11 should contain the following information:

1. Data on desorption of gases and vapors from the sorbent including a flow-temperature study at low and 

high temperature study at low and high temperatures and humidities: Data should be sufficient to 

demonstrate that the desorbed level of gases and vapors will not be harmful to the wearer.

2. Data on desorption of impregnating agents used in the cartridge/canister including flow-temperature 

study at low and high temperatures and humidities: Data should be sufficient to demonstrate safe levels 

of desorbed agents.

3. A list of catalytic products produced in the reaction of the sorbent with the contaminant gases and 

vapors, their concentrations and their toxicities.

4. Data on the toxicity of the impregnating agent(s) sufficient to insure that there is no creation of hazard to 

the wearer.

5. Family of breakthrough time curves at low & high temperatures, humidities & concentrations.

6. Data on the effects of the commonly found industrial interferences which could impair the ability of the 

respirator to protect the wearer (i.e., decreased Service Life).

Page 2 – All Respirator Manufacturers
3/12/2018 130 APR and CBRN APR 

We recognize the above list is by no means all inclusive. This is our attempt to itemize the types of 

information needed in order to determine the intrinsic safety of the respirator. All other information 

regarding wearer safety would aid NIOSH in their evaluation and would be welcomed in the application

For further technical information regarding these requirements, please contact the Testing and Certification 

Branch.

Sincerely Yours,

Nancy Bollinger

Supervisory Chemist

Air-Purifying Respirator Section

Testing and Certification Branch

Division of Safety Research
3/12/2018 131 APR and CBRN APR 

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 ApplicantAssigned 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 Part 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.
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Assembly Matrix - A diagram of all major subassemblies and accessories that apply to 

approvals in a respirator family. Components are identified by category, description, drawing 

number and revision, part number, and applicability to the listed approvals.

Authorized Representative - The person responsible for completing and submitting the 

Standard Application Form to NIOSH. This person can be an employee of the prospective 

approval holder or an independent consultant hired by the company to complete the Standard 

Application Form. Designated 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 airsupplied 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.
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Correlation Testing - Testing conducted to compare an applicant’s test equipment and results 

to NIOSH’s. The applicant must submit a new application with the wording “Correlation testing 

only; respirator is not submitted for approval” in the “Reason for Application” section. 

Critical Characteristic - A feature that, if not manufactured properly, could have an adverse 

impact on the safety or health of the user. 100% testing or inspection is required prior to 

shipment to ensure conformance with all technical requirements of the approval. 

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. 
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Filtering Facepiece - An N, R, or P class particulate respirator where the entire facepiece is 

composed of the filtering media. The unit may have an exhalation valve, but has no replaceable 

parts. 

Full Facepiece - A type of facepiece that covers a user from the hairline to below the chin. 

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

gases and vapors.

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. 
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Manufacturer’s Code - A unique three-letter code assigned to each approval holder by NIOSH.

Model Number - An identifier of a product given by the manufacturer. A model number is not 

required to identify each unique configuration. 

Mouthpiece - A respirator component that is held in the teeth with a clamp to close the nostrils 

that provides a gas-tight or dust-tight fit with the mouth. 

New Design - An entirely new or substantially modified respirator, component, or arrangement 

of components (some of which may have been used on previously approved respirators) which 

NIOSH has not evaluated in this configuration.

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.
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Pre-filter - An accessory item situated in front of the approved filter that removes coarse 

particles but does not meet 42 CFR Part 84 criteria for particulate filters. A pre-filter is a filter 

often used prior to an N-, R-, or P-series filter or cartridge. Pre-filters are not classified as N-, -R, 

or P-series filters. When pre-filters are used, the complete assembly must meet the resistance 

requirements of 42 CFR Part 84. Pre-filters may be listed on the approval labels. If shown on

the approval label, pre-filters must be listed as an accessory and designated as a pre-filter.

Pre-Submission Test Data - Respiratory performance test data must accompany each 

application and must specify components used for test configuration by part number, show 

units of measure for all test data (matching 42 CFR Part 84 criteria), and submit copies of actual 

test data with all results and conclusions. 

Performance - The actual operational performance of the respirator with respect to the 

applicable regulations and design parameters. The respirator must meet or exceed the 

requirements of the NIOSH regulations under 42 CFR Part 84 when evaluated against NIOSH 

standard test procedures (STPs) as appropriate to the type of respirator. 

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.
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Protection - A different type of protection is defined as protection against a different 

atmospheric contaminant (e.g., particulates, chlorine gas, ammonia gas, mercury vapor, etc.). A 

different level of protection is defined by a change in the type of facepiece (half-mask, full 

facepiece) or mouthpiece, filtering efficiency (such as N95 as opposed to N100), and/or the air 

supply capability (e.g., pressure, duration, demand flow, continuous flow, etc.).

Prototype - Defined as a respirator or component that (a) involves a new design produced using 

rapid prototyping methods, temporary tooling, non-production tooling, or regular production 

tooling in a new fashion, and (b) has demonstrated by the applicant’s pre-testing to meet 42 

CFR Part 84 minimum design and performance requirements. Respirators may not be 

submitted for approval while in this defined prototype stage (limited production tooling and 

processes). NIOSH will request samples made on regular production tooling and production 

quality control (Ref. 84.30 (c)) if the approval holder request approval. For non-approval 

prototype testing use a new application form and state “Prototype Testing Only - Respirator is 

Not Submitted for Approval” in the “Reason for Application.”

Quality Assurance (QA) - A planned and systemic pattern of all activities necessary to provide 

confidence that all respirators will perform satisfactorily in operation.

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

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

implementing 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 NIOSHApproved. Respirators are not listed in the CEL.

Respirator - Any device designed to provide the wearer with respiratory protection against 

inhalation of a hazardous atmosphere.
3/12/2018 138 APR and CBRN APR 

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 selfcontained 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.

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.
3/12/2018 139 APR and CBRN APR 

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
3/12/2018 140 APR and CBRN APR 

HSBG - Human Subject Breathing Gas

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
3/12/2018 141 APR and CBRN APR 

SOP - Standard Operating Procedure

STP - Standard Test Procedure

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

TN - Task Number; a unique number assigned by NIOSH to each application
3/12/2018 142 APR and CBRN APR 

Revision History

Date Section Action

12-Dec-17

Section 1

1.1.9

Submitting Test 

Samples

Added: All sample components must be identified and labeled with the 

corresponding part number as listed on the assembly matrix.

12-Dec-17

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 extension 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-Dec-17

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-Dec-17

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-Dec-17

Section 2

11 (Section C.11) 

Description of

Respirator

After the 11th entry "If the respirator contains electrical components, 

have the components been approved by MSHA for intrinsic safety? 

Added: 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-Dec-17

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-Dec-17

Section 3

3.1 Quality 

Assurance 

Documentation Second paragraph. Third sentence. Added: in a separate QA application,
3/12/2018 143 APR and CBRN APR 

12-Dec-17

Section 3

3.5 Air-Purifying 

Respirator and 

CBRN AirPurifying 

Respirator Test 

Fees

Paragraph under Test Fees to be Charged for New and Unspecified 

Tests: Deleted: Do not issue a single payment (check or pay.gov) for 

multiple invoices. Separate payments (check or pay.gov) are required for 

each application invoice received. Include the AAR# on the payment so it 

is properly credited.Added: A single payment (check or pay.gov) for 

multiple invoices is allowed. Include the AAR#s for each associated 

application on the check or the pay.gov receipt so they will be properly 

credited. Separate payments (check or pay.gov) will also be allowed for 

each application invoice. For application fee invoices, include the TN 

number(s) associated with the payment. To indicate a final payment for a 

specific application(s), add a -F after the TN number(s) (TN-nnnn-F).

12-Dec-17

Section 3 

3.13 

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

12-Dec-17

Section 3

3.14 Special 

Instructions

Sixth paragraph. Staring with For all Air-Purifying Respirators that include 

a nuisance ... Added: under a Special "S" titled listing.

12-Mar-18

Section 3.17 

Summary of 

Related 

Documents

Added to the end: In addition to the application file, the manufacturer 

must submit related project documentations. 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.

12-Dec-17

Section 8 

Label Format 

Guidance

10th bullet. Changed from: The abbreviated label mounted on AirPurifying Respirators must clearly indicate the approval holder's name, 

product model or trade name, protections, part number, and lot number. 

To: The abbreviated label mounted on filters or cartridges for AirPurifying Respirators must clearly indicate the approval holder's name, 

product model or trade name, protections, part number, and lot number.

The entire label must appear in the User Instructions.

12-Dec-17

Appendix

Acronyms Added: CAR - Corrective Action Request