8/4/2022 SCBA and CBRN SCBA

1

National Institute for Occupational Safety and Health (NIOSH)

National Personal Protective Technology Laboratory (NPPTL)

Conformity Verification and Standards Development Branch (CV&SDB)

The Standard Application Procedure

for the Approval of

Self-Contained Breathing Apparatus and

Chemical, Biological, Radiological, and Nuclear

Self-Contained Breathing Apparatus

Under 42 CFR Part 84

Revised: August 4, 2022
8/4/2022 SCBA and CBRN SCBA

2 

Table of Contents

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

Section 1 General Information for Self-Contained Breathing Apparatus or CBRN SCBA ....................................... 6

1.1 Getting Started............................................................................................................................................. 6

1.1.1 Who May Apply ................................................................................................................................. 6

1.1.2 Approval............................................................................................................................................. 6

1.1.3 Applicants Without a Three Character Manufacturer’s Code.......................................................... 6

1.1.4 Applicants Without a NIOSH Approval ............................................................................................. 6

1.1.5 Where to Find the Standard Application Form................................................................................. 7

1.1.6 Submitting the Application ............................................................................................................... 7

1.1.7 Documents to Submit with the Application ..................................................................................... 7

1.1.8 Submitting the Application and Associated Documents................................................................... 7

1.1.9 Submitting Test Samples (Hardware) ............................................................................................... 8

1.2 Types of Applications................................................................................................................................... 8

1.2.1 New Approval Application ................................................................................................................. 8

1.2.2 Extensions of Approval Application.................................................................................................. 9

1.2.3 Quality Assurance Approval Application ........................................................................................ 13

1.2.4 Resubmission of Applications ......................................................................................................... 14

1.2.5 Amended Application...................................................................................................................... 14

1.2.6 Correlation Testing Only Application.............................................................................................. 14

1.3 Approval Label Protections and Cautions and Limitations for SCBA and CBRN SCBA............................. 15

Section 2 Specific Instructions for Preparing a SCBA or CBRN SCBA Application Package................................... 16

Section 3 Supplemental Information for Preparing a SCBA or CBRN SCBA Application.......................................26

3.1 Quality Assurance Documentation ........................................................................................................... 26

3.2 Quality Assurance Manual......................................................................................................................... 26

3.3 Product Quality Control Plan and Documentation................................................................................... 27

3.4 Fees ............................................................................................................................................................ 28

3.5 Combination Supplied-Air Respirators and SCBA, SCBA, or CBRN SCBA Test Fees ................................. 29

3.6 Annual (Fixed) Certification (Approval) Fees............................................................................................ 30

3.7 Pay.Gov Instructions.................................................................................................................................. 32

3.8 Drawings for a Self-Contained Breathing Apparatus or CBRN Self-Contained Breathing Apparatus.... 34

3.8.1 Exploded-View Drawing and Major Subassembly Drawing for a SCBA or a CBRN SCBA .............. 34

3.8.2 Example of an Exploded-View Drawing for an SCBA or a CBRN SCBA........................................... 35

3.8.3 Major Subassembly Drawings for a SCBA or a CBRN SCBA............................................................ 35
8/4/2022 SCBA and CBRN SCBA

3 

3.8.4 Material Specifications on Drawings for a SCBA or a CBRN SCBA.................................................. 36

3.9 Component Vendors.................................................................................................................................. 36

3.10 Assembly Matrix ...................................................................................................................................... 36

3.11 Approval Labels and Private Labels......................................................................................................... 38

3.12 List of NIOSH Cautions and Limitations for SCBA or CBRN SCBA ........................................................... 38

3.13 Private Labeling Versus Private Packaging............................................................................................. 39

3.14 User Instructions...................................................................................................................................... 40

3.15 Packaging Art Work and Carton Design .................................................................................................. 41

3.16 Summary of Related Documents............................................................................................................. 42

3.17 File Naming Conventions......................................................................................................................... 43

Section 4 Approvals and Denials............................................................................................................................ 45

4.1 Approval Documentation .......................................................................................................................... 45

4.2 Denial Documentation............................................................................................................................... 45

4.3 Denial Prior to Assignment of a Task Number.......................................................................................... 45

4.4 Denial of a Project Undergoing NIOSH Evaluation ................................................................................... 46

4.5 Respirator Certification (Approval) Program Decision Review Process................................................... 46

Section 5 Test Selection Guide for Self-Contained Breathing Apparatus and CBRN SCBA.................................. 47

Section 6 Checklists for Self-Contained Breathing Apparatus or CBRN SCBA....................................................... 59

6.1 NIOSH Respirator Application Checklist.................................................................................................... 59

6.2 Exploded-View Drawing Checklist for a Self-Contained Breathing Apparatus or CBRN SCBA................ 61

6.3 Major Subassemblies Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA.................. 62

6.4 Self-Contained Breathing Apparatus or CBRN Self-Contained Breathing Apparatus.............................. 63

6.5 Supplied-Air Respirator ............................................................................................................................. 65

6.6 Private Label Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA ............................... 66

6.7 Assembly Matrix Checklist for a Self-Contained Breathing Apparatus or a CBRN SCBA........................ 67

Section 7 - Document Examples for a Self-Contained Breathing Apparatus or a CBRN SCBA ................................. 68

7.1 Example of a Product Quality Plan for a Self-Contained Breathing Apparatus or a CBRN SCBA ............ 68

7.2 Example of an Assembly Matrix for a Self-Contained Breathing Apparatus........................................... 70

7.3 Example of an Assembly Matrix for a CBRN Self-Contained Breating Apparatus................................... 71

7.4 Example of an Exploded-View Drawing for a SCBA or a CBRN SCBA ....................................................... 72

7.5 Example of an Approval Label for a Self-Contained Breathing Apparatus.............................................. 73

7.6 Example of an Approval Label for a CBRN Self-Contained Breathing Apparatus.................................... ....74

7. 7Example of an Approval Label for a SCBA and Combination SCBA/SAR......................................................76

7.8 Example of an Approval Label for a SCBA Harness.......................................................................................78
8/4/2022 SCBA and CBRN SCBA

4 

7.9 Example Approval Label for CBRN Self-Contained Breathing Apparatus Harness.................................. 79

Section 8 Label Format and Guidance.................................................................................................................... 80

Appendix..................................................................................................................................................................... 81

Letter to All Respirator Manufacturers...................................................................................................................... 81

Definitions ................................................................................................................................................................... 92

Acronyms...................................................................................................................................................................100
8/4/2022 SCBA and CBRN SCBA

5 

Introduction

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

dated August 2015. It is intended to add clarity to the approval process under Title 42, Code of Federal 

Regulations (CFR) Part 84 (also known as 42 CFR Part 84). It is recommended that applicants review the 

entire document before submitting a respirator for approval. 

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

(SAF). 

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

pertain to the approval of Self-Contained Breathing Apparatus (SCBA) and Chemical, Biological, 

Radiological, and Nuclear Self-Contained Breathing Apparatus (CBRN SCBA). Please see the appropriate 

application for the type of respirator being submitted.

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

Schedule 13F

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

• Self-Contained Self-Rescuers; Combination Escape Only Self-Contained Breathing

Apparatus/Supplied-Air Respirator; and

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

Schedule 13F-CBRN

• Self-Contained Breathing Apparatus for Entry or Escape, Pressure-Demand, Open-Circuit with

Chemical, Biological, Radiological, and Nuclear Protection for Use in Firefighting and in

Conjunction with Safety Equipment Institute and the National Fire Protection Association.

Compliance with all instructions is essential for efficient processing of an application. 

The information in Section 2 of this document provides specific step-by-step instructions to prepare an 

application for a Self-Contained Breathing Apparatus or Chemical, Biological, Radiological, and Nuclear

Self-Contained Breathing Apparatus. The paragraphs are numbered to correspond with the sections of 

version 8 of the standard application form (SAF). 

Additional guidance and information related to SCBAs and CBRN SCBAs is included in the sections that 

follow and should be used as reference.
8/4/2022 SCBA and CBRN SCBA

6 

Section 1 General Information for Self-Contained Breathing 

 Apparatus or CBRN Self-Contained Breathing 

 Apparatus 

Instructions for Preparing an Application for a Self-Contained Breathing Apparatus

(SCBA) or a CBRN Self-Contained Breathing Apparatus (CBRN SCBA) (13F or 13F-CBRN 

Approvals)

This guide applies strictly to SCBAs and CBRN SCBAs. Please see the appropriate 

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

respirators. 

1.1 Getting Started

1.1.1 Who May Apply

An individual, partnership, company, corporation, association, or other organization that designs, 

manufactures, assembles, or controls the assembly of a respirator may apply to NIOSH to become an 

approval holder (42 CFR Section 84.2). An organization may appoint an authorized representative to 

complete and submit the Standard Application Form (SAF) to NIOSH.

1.1.2 Approval

Approval is issued once NIOSH determines the product conforms to the requirements of 42 CFR Part 84.

1.1.3 Applicants Without a Three Character Manufacturer’s Code

A prospective approval holder that has not applied for a NIOSH-Assigned three character manufacturer’s 

code will need to complete the Prospective Approval Holder Form and return it to the NIOSH NPPTL 

Records Room. To obtain the form, contact the NIOSH NPPTL Records Room at recordsroom@cdc.gov

or (412) 386-4000.

1.1.4 Applicants Without a NIOSH Approval

Prospective approval holders, without a NIOSH-Approved respirator, who have received a three 

character manufacturer’s code, may submit an initial application for a single new respirator along with a 

signed and approved company Quality Assurance (QA) Manual. 

For prospective approval holders, once the application is accepted, reviewed, the respirator is tested, 

and a final review is successfully performed, a site qualification visit will be scheduled and conducted

prior to the issuance of any approval. Please see the fee schedules for the cost of the site qualification. 

Other applications may be submitted with the initial application. However, subsequent applications will 

not be reviewed until the site qualification is completed and the initial application is approved.
8/4/2022 SCBA and CBRN SCBA

7 

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

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

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

every two years. 

1.1.5 Where to Find the Standard Application Form

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

versions 8 and 9 may be requested from the NPPTL Records Room once the manufacturer’s code is 

issued.

1.1.6 Submitting the Application

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

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

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

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

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

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

stripped by mail routers. 

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

(AAR#). For the CBRN SCBA application, use the same AAR# but add the CBRN on the end. Example:

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

1.1.7 Documents to Submit with the Application

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

are included in Section 3. Tests required for the specific respirator type are included in Section 5. 

Documents must be named in accordance with the prescribed naming convention, using an acceptable 

software package. 

1.1.8 Submitting the Application and Associated Documents

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

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

NIOSH NPPTL

CV&SDB, Records Room

626 Cochrans Mill Road

Pittsburgh, PA 15236
8/4/2022 SCBA and CBRN SCBA

8 

1.1.9 Submitting Test Samples (Hardware) 

NIOSH NPPTL

CV&SDB, Evaluation and Testing

626 Cochrans Mill Road

Pittsburgh, PA 15236

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

slip.

Test samples (hardware) submitted for a series of applications must be identified for each project which 

it is to be used. For example, a Self-Contained Breathing Apparatus (SCBA) that is to be used on three 

projects, because the respirator has three different pressure reducers, must have all three ApplicantAssigned Reference Numbers (AAR#s) on the packaging. If there are multiple containers, each container 

must be labeled with all the appropriate information.

All sample components must be identified and labeled with their corresponding part numbers as listed 

on the assembly matrix.

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

information in the first application where testing will be performed and label the test samples

(hardware) package with each AAR#. 

1.2 Types of Applications

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

Assurance Approval Application, Amended Application, Correlation Testing Only Application, 

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

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

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

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

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

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

the respirator in the CEL.

New Approval Applications and Extension of Approval Applications must contain or reference the 

following items as described in detail in Section 2 and 3 of this SAP. 

1.2.1 New Approval Application

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

protection requested for an existing NIOSH-Approved respirator.
8/4/2022 SCBA and CBRN SCBA

9 

• NIOSH assigns a new testing and certification (TC) number for each new respirator system design

that is approved.

• An application may be submitted for only one basic new respirator design per application.

• Applications containing more than one design will be denied.

o For example, if an applicant submits a new respirator with and without an air-line

connection that uses the same regulator assembly, NIOSH requires two separate

applications resulting in two new approvals because each arrangement represents a

separate design and limitations for different uses.

• New Approval Applications must contain or reference the following items as described in detail

in Sections 2 and 3 of this SAP.

• NIOSH Standard Application Form.

• Pretest Data.

• Simplified Drawings.

• Assembly Matrix.

• Draft Approval Label(s).

• Quality Assurance Manual (Manual to be submitted separately as QA application after first

approval).

• Product Quality Control Plan.

o Classification of Defects Document.

o Sampling Plan.

• Application Fee, $200.

• User Instructions.

• Test Samples (Hardware).

1.2.2 Extensions of Approval Application

Submitted when: 

• A critical or major characteristic affecting performance is altered on a previously approved

respirator.

• A critical or major characteristic affecting design (including Quality Assurance provisions) is

altered on a previously approved respirator.

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

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

• A product is made obsolete.

• The approval holder wants to add multiple components to one previously approved SCBA.

• All the TC numbers on a given assembly matrix apply to the extension. The assembly matrix may

be referenced in lieu of listing the individual TC numbers.

• All TC numbers affected must be listed in the “Reason for Application.”
8/4/2022 SCBA and CBRN SCBA

10

Additional Components Previously Approved SCBA

• An approval holder wants to add a component multiple previously approved respirators.

Component Previously Approved SCBAs 

The approval holder, 

company ABC, requests a 

single accessory be added 

to multiple previously 

approved SCBAs.

TC-13F-1234

TC-13F-2345

TC-13F-1357

The approval holder, 

company ABC, requests the 

addition of multiple 

accessories to a previously 

approved SCBA described in 

TC-13F-xxxx

Radio Interface

Regulator Docking Bracket

Spectacle Kit
8/4/2022 SCBA and CBRN SCBA

11

Changes to minor characteristics not affecting performance or design which are not documented in the 

NIOSH approval records do not have to be submitted to NIOSH. A minor characteristic is an attribute, 

such as the size of the belt loops on the harness. Approval holders are responsible for keeping all 

changes to minor characteristics on file and available for review at the request of NIOSH.

This includes any minor changes to any document that is part of the approval record. These changes 

should be submitted for an extension of approval at your earliest convenience. Note, documents not upto-date in the NIOSH record could be identified during a site audit and resulting in a non-conformance.

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

an SCBA with a 4500 pressure cylinder and 30 minute service time may be submitted and approved. The 

subsequent submission of the same SCBA with the same pressure cylinder but with a 45 minute service 

time would be considered to be a new ‘Type,’ requiring a New Approval Application and a different TC 

number being issued. 

In addition, a New Approval Application is required and a different TC number will be issued for 

additions of a new respirator arrangement to a respirator family, model, or series such as a new 

facepiece on an existing SCBA model. 

Extension of Approval Applications must contain the following items or reference as described in detail 

in Sections 2 and 3 of this SAP.

• NIOSH Standard Application Form.

• Pretest Data.

• Simplified Drawings.

• Assembly Matrix.

• Draft Approval Label(s).

• Product Quality Control Plan.

o Classification of Defects Document.

o Sampling Plan.

• Application Fee, $200.

• User Instructions.

• Test Samples (Hardware).

In the “Reason for Application”: Describe exactly and completely the change(s) or addition(s) to the 

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

a succinct description on the previously approved respirator(s). For example, "An Extension of Approval 

to allow our ‘xyz’ alternate second stage regulator to our SCBA models 123, 456, and 789. No other 

respirators are affected. This request is for use of an alternate second stage regulator only." The 

Extension of Approval Application request must clearly indicate:
8/4/2022 SCBA and CBRN SCBA

12

1. The affected respirator(s) by name, TC number, and part number. If multiple approvals are

affected, the assembly matrix or matrices that contain these approvals may be listed in lieu of

the TC numbers.

2. Complete details of the change(s) or addition(s).

3. Related documentation that has changed since the last approval (assembly matrix, inspection

procedures, simplified drawings, draft approval label, product quality control plan, User

Instruction).

Example of a Well-Written Reason for Extension of Approval Application: 

Provides the model number, TC number, type of respirator, and what is being requested in a 

very descriptive manner. In this example, the request is to allow four new air-line/manifold 

pneumatic components, a new supplement to the User Instructions, and to add additional 

hose/handwheel assemblies. The details are provided. 

This Extension of Approval Application is for a modification of approvals TC-13F-123, TC-13F-456, 

TC-13F-789, and TC-13F-234 issued for the Eagle Open-Circuit, Pressure-Demand, Entry and 

Escape, Self-Contained Breathing Apparatus or Combination, Open-Circuit, Pressure-Demand, 

Entry and Escape, Self-Contained Breathing Apparatus and Type C, Supplied-Air Respirator to

make the following changes as indicated on assembly matrix Eagle_AM26.XLS: 

• To add four new airline/manifold pneumatic components, part numbers 1000001,

1000002, 1000003, and 1000004.

• To add a new supplement to the User Instructions part number A000009 for the air-line

attachments.

• To add hose/handwheel assemblies 1005 and 1006 to backframes 1007 and 1008 and

remove hose/handwheel assemblies 1000 and 1001.

Specifies the change(s)

This request is for the use of an alternate pneumatic accessory, change a handwheel assembly, 

and update the User Instructions. No other components or processes are affected. All the 

changes pass the testing required to meet the criteria for an SCBA and a Supplied-Air Respirator. 

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

The current designs do not allow the user the option of using different manifolds, and the 

current handwheel is somewhat difficult to manipulate when wearing gloves. The new 

arrangements allow the user to pick a manifold that suits their needs and the new handwheel is 

easier to manipulate when wearing gloves. 

Any time the approval holder makes a change to a critical or major characteristic, as defined in 42 CFR 

Part 84, affecting performance and/or design (including Quality Assurance provisions), the change must 

be submitted to NIOSH for approval. NIOSH will not assign new approval (TC) numbers for Extension of 

Approval Applications. New approvals can only be granted under a New Approval Application.
8/4/2022 SCBA and CBRN SCBA

13

NIOSH will not assign new approval (TC) numbers for Extensions of Approval Applications. New 

approvals can only be granted under a New Approval Application. 

For SCBAs only, an Extension of Approval Application is acceptable for multiple changes affecting a single 

SCBA even if it affects several major subassemblies.

For SCBAs with both Part 84 and CBRN approval, a Part 84 Extension of Approval Application cannot 

contain changes to the CBRN approval. The only documents that may be submitted with this type of 

application are those that are applicable to the Part 84 extension. When adding an accessory to an 

already approved assembly, the applicant must include the accessory in the exploded-view drawing, the 

assembly matrix, and the major subassembly drawings. If accessories are listed on the approval labels, 

the labels must be updated.

Extensions of Approval Applications to add alternate components to respirators previously approved by 

NIOSH apply to respirators that will be shipped from the manufacturer’s plant in the various 

configurations. These Extensions of Approval Applications are not meant to apply to configuration 

changes that will be done in the field either by the end user or by manufacturer representatives. If the 

alternate components are to be field-replaceable, the approval holder must submit an Extension of 

Approval Application for an upgrade (or retrofit) kit. The applicant must submit one application for each 

upgrade (retrofit) kit that is being issued. The upgrade (retrofit) kit can be in the form of a parts list or a 

drawing, and it must be listed on the assembly matrix with its own controlled document number and 

revision level. If the upgrade (retrofit) kit is submitted as a picture drawing, the drawing must contain a 

parts list. The manufacturer’s User Instructions to the field personnel or technician conducting the 

upgrade (retrofit) must also be submitted as a controlled document and listed on the matrix. The first 

time these items are listed on the matrix they will have a matrix code of “N.” Subsequent submittals will 

be designated with a “R.”

When changes are made that affect the User Instructions, highlight or clearly note the changes in the 

document. 

1.2.3 Quality Assurance Approval Application

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

approval holders only.

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

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

for revision.

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

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

the requestor has at least one NIOSH-Approved product.
8/4/2022 SCBA and CBRN SCBA

14

In the “Reason for Application” state the details of the changes to the QA Manual. Also, indicate the 

respirator(s) and manufacturing facility(ies) affected. 

QA Approval Application submissions must not affect the performance or design of the respirator(s) and 

must not result in a different type or level of protection. If the changes impact any of these aspects of 

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

these changes.

1.2.4 Resubmission of Applications 

• Resubmissions are only accepted when allowed by NIOSH.

• Used for hardware or documentation previously denied by NIOSH.

If an application is for hardware or documentation that has been previously submitted to NIOSH and 

denied, select request type ‘Resubmittal of New Application’ or ‘Resubmittal of Extension Application’ as 

appropriate. The “Reason for Application” must include the changes made to address the respirator or 

documentation deficiencies, an explanation of how the respirator or documentation now meets NIOSH 

requirements, and the task number (TN) of the previously denied application. Failure to provide this 

information will result in the application being denied again. 

1.2.5 Amended Application

• Amended Applications are only accepted when requested by NIOSH.

• Used for open applications with an identified inaccuracy.

• Only the portion requested by NIOSH should be submitted.

• The AAR# and TN will remain the same.

1.2.6 Correlation Testing Only Application

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

Testing Procedures (STPs). NIOSH will only perform correlation testing using one of the NIOSH Standard 

Test Procedures. The results of this testing cannot be used as pre-submission test data when submitting 

the respirator for NIOSH approval. No approval will be issued with a Correlation Testing Only 

Application.

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

testing is required, by STP number. NIOSH will only test the number of samples specified in the STP or 

42 CFR Part 84. Specify the number of trials in the “Reason for Application” section.
8/4/2022 SCBA and CBRN SCBA

15

1.3 Approval Label Protections and Cautions and Limitations for 

Self-Contained Breathing Apparatus and CBRN Self-Contained 

Breathing Apparatus 

PROTECTIONS

CBRN - Chemical, Biological, Radiological, and Nuclear

CF - Continuous Flow DE - Demand ESC - Escape 

PD - Pressure-Demand SA - Supplied-Air SB - Supplied-Air Abrasive Blast

SC - Self-Contained 

EOSTI-25 - End-of-Service-Time Indicator 25%

EOSTI-33 - End-of-Service-Time Indicator 33%

CAUTIONS and LIMITATIONS 

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres.

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, 

OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the 

configuration as specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance 

of these respirators.

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

Instructions before donning.

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

respiratory hazards.

CBRN-SPECIFIC CAUTIONS and LIMITATIONS

Q Use in conjunction with personal protective ensembles that provide appropriate levels of 

protection against dermal hazard.

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

impairment, illness, or death.

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

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

be followed. If contaminated with liquid chemical warfare agents, dispose of the respirator after 

decontamination.

U The respirator should not be used beyond 6 hours after initial exposure to chemical warfare 

agents to avoid possibility of agent permeation.
8/4/2022 SCBA and CBRN SCBA

16

Section 2 Specific Instructions for Preparing a Self-Contained 

Breathing Apparatus or CBRN Self-Contained Breathing 

Apparatus Application Package 

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

version 8 of the Standard Application Form (SAF). 

1 Project Reference Numbers (Section C.1)

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

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

Assign a unique reference number to this application. 

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

There is no character limit on this reference number.

This number must appear on each hardware sample package and the payment. 

Never reuse the Applicant-Assigned Reference Number (AAR#) except on Amended Applications 

requested by NIOSH.

NIOSH assigns a unique Task Number (TN) to each project. 

This number is emailed to the applicant once the application is received along with accompanying 

documents, check or payment confirmation, and test samples (hardware). 

All inquiries must refer to either the NIOSH-Assigned TN or the AAR#. 

2 Type of Application (Section C.2)

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

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

Correlation Testing Only Application, or Amended Application. 

New Approval Application

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

protection requested for an existing NIOSH-Approved respirator.

Resubmission of New Approval Application

• Resubmission will only be accepted when allowed by NIOSH.

• Used for previously denied applications.

Extension of Approval Application

• A change is made to any document that was evaluated by NIOSH as part of an approval.

• A critical or major characteristic affecting performance or design (including Quality

Assurance provisions) is altered on a previously approved respirator.
8/4/2022 SCBA and CBRN SCBA

17

• One new accessory is added to a previously approved respirator.

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

• A private label request is made.

• A product is made obsolete

Resubmission of Extension of Approval Application

• Resubmission applications are only accepted when allowed by NIOSH.

• Used for previously denied applications.

Quality Assurance Approval Application

• Choose this application for a new or updated QA Manual only.

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

Correlation Testing Only Application

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

NIOSH STPs.

• The results of this testing cannot be used as pre-submission test data when submitting

the respirator for NIOSH approval.

• Independent or internal testing is still required prior to submission of the application.

• Explain what testing is required and how many trials in the “Reason for Application.”

• No approval will be issued with a Correlation Testing Only Application.

Amended Application

• Amended submissions are only accepted when requested by NIOSH.

• Used for open applications with an inaccuracy in the application.

• Only the portion requested by NIOSH should be submitted.

• The AAR# and TN will remain the same.

3 and 5 Prospective Approval Holder (Section C.3 and Section C.5)

Enter the name of the prospective approval holder. 

Status of Facility Manufacturer/Approval Holder Name (if different than above).

Check if the organization has submitted a request for approval for any respirator produced at this 

manufacturing plant in the last three years. 

Applicant – A person identified by the approval holder as completing and submitting the application.

Primary Contact – Person who will receive the approval or denial letter and all correspondence 

concerning the application.
8/4/2022 SCBA and CBRN SCBA

18

Only those persons identified to NIOSH by the manufacturer/approval holder as official company 

contacts should be listed on the application. Multiple contacts can be identified as required by the 

manufacturer/approval holder. 

Enter Official Title.

Enter the first and last name, middle initial, and suffix for the applicant.

Enter the name of the prospective approval holder, if different from above. 

Enter the manufacturing plant address. 

Enter the manufacturing plant phone number. 

Click “add contact” to add information for another person who can answer questions related to this 

application.

6 Date of Application (Section C.6)

Choose the date from the drop down calendar. The NIOSH date of application is when the application is 

assigned a TN by NIOSH.

7 Type of Product (Section C.7)

Select Air-Supplying since this application applies only to Self-Contained Breathing Apparatus 

Respirators.

8 Specific Questions Pertaining to Submission (Section C.8)

Is this a resubmittal of a previous application?

If Yes, enter the previous TN.

Is this an amended application?

Yes or No.

Is this submission application a result of field problem or site audit?

If Yes, enter the relevant TN(s). 

Is the respirator intended for use in mines?

Yes or No.

This is for Part 84 applications only.

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

If Yes, specify the applicable AAR# or TN. 
8/4/2022 SCBA and CBRN SCBA

19

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

the first application is approved. 

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

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

same assembly matrix cannot be processed until the first application is approved. Additionally if a drawing 

is currently under review at NIOSH and a separate matrix is submitted, the current application should indicate that 

the project is dependent on the prior project and applicants should list the applicable TN.

9 Reason for Application (Section C.9)

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

to respirator use or future respirator development. This is the information that will appear in the CEL. 

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

• If making respirators obsolete, include the TC numbers and model numbers.

List the TC numbers of all approvals affected by the application. If all of the TC numbers on the assembly 

matrix apply to the extension, the assembly matrix may be referenced instead of the individual TC 

numbers. 

If an Extension of Approval Application is the result of a field problem, site audit, or product audit, state 

that fact and list any associated task numbers (TN) here. Also, list the Corrective Action Request (CAR) 

number associated with the application.

Please do not list “approval” as the “Reason for Application.”

Quality Assurance Approval Applications must state the details of the change(s) to the QA Manual and 

the respirator(s) and manufacturing facility(ies) affected. QA Approval Applications must not affect 

performance or design and must not result in a different type or level of protection.

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

and indicate how many trials are requested. Special correlation tests that are not consistent with a 

NIOSH Standard Testing Procedures will not be conducted unless previously agreed upon by NIOSH. An 

approval will not be issued with a Correlation Testing Only Application.

Resubmittals must state the modification(s) that was (were) made to address the rejection/denial, and 

demonstrate that the respirator or documentation now meets all requirements.
8/4/2022 SCBA and CBRN SCBA

20

10 Approval History (Section C.10)

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

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

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

Include a suggested processing order. Include an explanation how the applications build upon each 

other. When using a common assembly matrix for the entire series of applications, place the assembly 

matrix in the last application of the series and reference the application in which it is located in all 

applications in the series. Applications in a series will not be approved until the entire series is 

complete. 

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

Example of a Well-Written Approval History for a Self-Contained Breathing Apparatus: 

The new mask material is documented on revised specification sheet ZM-FL-A02 Rev A.

The change is documented in the mask's bill of materials (Item 2) on page 3 of drawing 103-01 

Revision M.

This modification does not affect the respirator performance, but may affect facepiece fit. Happy 

Breathing Company has tested the facepiece covering this extension and finds that it still meets 

the requirements of 42 CFR Part 84 for facepiece fit. Happy Breathing Company has not changed 

any of the respirator components since the components were granted NIOSH approval under TNxxxxx. The Happy Breathing Company is relying on the facepiece fit data accompanying this 

submission, AAR#ph24, to obtain this approval.

This change will be applicable to the XXX mask and III respirator and private labels YYY & ZZZ.

11 Description of Respirator (Section C.11)

Information for New Approval Applications and Extension of Approval Applications is entered in the SAF

by selecting options from dropdown options. The respirator description fields vary based on the type of 

respirator selected. Both New Approval Applications and Extension of Approval Applications require a 

detailed narrative description.

Is this a joint SEI (CBRN NFPA) submission?

Yes or No. 

Is this an SEI retrofit respirator? 

Yes or No.

Is this a CBRN application?

Yes or No. 
8/4/2022 SCBA and CBRN SCBA

21

Select type of CBRN, if applicable.

In this case, select SCBA if submitting for CBRN approval. 

Is testing required?

Yes or No. 

Return sample hardware? 

Yes or No. 

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

Source of submitted samples – Choose from dropdown options: 

Prototype, Regular Production Unit, Correlation Test Sample. 

If no testing is required, please provide the reason.

Facepiece type – Choose from the dropdown options:

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

Tight-Fitting Full Facepiece with Neckdam Seal.

Fit – Choose from the dropdown options: 

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

Is this respirator fit checkable?

Yes or No. 

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

intrinsic safety?

Yes, No, or Not Applicable. 

Note: If the respirator is to be used in underground mines or for mine rescue and has electronics, 

MSHA intrinsic safety approval must be received prior to submitting to NIOSH. However, if the 

respirator is not intended for mine use or mine rescue, then the unit’s electrical components do not 

require MSHA approval.

Does the respirator have an inhalation valve?

 Yes or No.

Does the respirator have an exhalation valve?

Yes or No.

Move to Air-Supplied Respirator Questions

Type of Supplied-Air Respirator – Choose from dropdown options: 
8/4/2022 SCBA and CBRN SCBA

22

Self-Contained Breathing Apparatus (SCBA), Supplied-Air Respirator (SAR), or Combination 

SCBA/SAR. 

SCBA Type – Choose from dropdown options: 

Open-Circuit, Closed-Circuit, or Other Technology. 

SCBA Use – Choose from dropdown options: 

Escape-only or Entry and Escape. 

SAR Category – Choose from dropdown options: 

A, AE, A and AE, B, BE, B and BE, C, CE, C and CE, or Other.

Selected the Rated Service Time (minutes):

3, 5, 10, 15, 30, 45, 60, 120, 180, or 240.

Airflow – Choose from dropdown options: 

Demand, Pressure-Demand, Continuous Flow, or Negative Pressure.

Breathing Gas – Choose from dropdown options: 

Compressed Air, Compressed Oxygen, Compressed and Rich Air, Chemical Oxygen, Liquid 

Oxygen, or Other Technology. 

Enter the Concentration of Oxygen in Breathing Gas (percentage).

Enter the Cylinder Rating (psi).

Regulator Mounting Location – Choose from dropdown options: 

Belt, Chest, Facepiece, Back or Backpack, or Helmet.

Are the materials used in the construction which may be exposed to oxygen at pressures above 

atmospheric pressures, safe and compatible for their intended use?

Yes or No.

If a hose set is needed, click on “Add Hose Set” and provide the model number, hose type, shortest 

length, maximum length, other lengths, total sections, valve type, and pressure.

Also provide a description of the respirator(s).

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

Atmosphere-Supplying respirators only:
8/4/2022 SCBA and CBRN SCBA

23

Confirm that any materials used in the construction of the respirator which may be exposed to oxygen 

pressures above atmospheric pressure are safe and compatible for the intended use (e.g., exposure to 

elevated concentrations of oxygen).

Identify CBRN when applicable.

The term “Intended for Mine Use” identifies respirators to be used for emergency use in mines. NIOSH

requires this information to determine if the application must be evaluated and approved by both 

NIOSH and the Mine Safety and Health Administration (MSHA). Respirators to be used for mine rescue 

and other emergency use in mines must be approved by MSHA under 30 CFR Part 75.1714. In addition, 

if the respirator has electrical components, MSHA intrinsic safety approval must be received prior to 

submitting to NIOSH. Any questions regarding the need for joint approval, please call NIOSH at 412-386-

4000. 

13 Pre-Submission Performance Test Data and Statements (Section C.13)

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

• Specify components used for test configuration by part number.

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

H through J criteria).

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

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

Respirator Test Selection Guide. NIOSH expects that applicants will have performed each NIOSH test 

and any additional tests the applicants deem appropriate during the process of validating that the device 

meets NIOSH approval requirements.

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

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

the EOSTI information is contained. See Approval Labels in Section 7 for an example.

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

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

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

listed in the Certified Equipment List for public reference. In version 8 of the electronic standard 

application form for a New Approval Application, the model number field can be blank, but the product 

trade name field must be completed before proceeding to the next data screen. A product trade name 

may indicate a protection, but it may not imply use. Model numbers previously used for particulate 

filtering devices approved under 30 CFR 11 standards may not be reused or carried over to devices or 

configurations to be approved under 42 CFR Part 84 standards.
8/4/2022 SCBA and CBRN SCBA

24

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

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

(42 CFR Section 84.11(e)). 

Applications will be denied if the test samples (hardware) provided for testing did not go through the 

manufacturer’s normal assembly, inspection, and test processes.

Applications may be denied even if the component that failed is not related to the “Reason for 

Application.” 

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

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

application. The hardware samples to be used for testing must be sent under a separate cover from the 

application. In the application and on the packing slip with the hardware samples, list the item by part 

number and description, and indicate the quantity submitted for testing. Include a copy of the User 

Instructions in the box or shipping container with the hardware samples to be used for testing. 

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

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

The hardware samples to be used for testing and any additional hardware samples requested by NIOSH 

must clearly show the part number on each item, as it is listed on the assembly matrix, regardless of 

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

the shipment to the attention of the NIOSH employee requesting the samples. Include the AAR#, TN, 

and state “Additional Test Samples” on the outside of the box or shipping container. Cross-referenced 

lists will not be accepted.

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

hardware samples for any materials to be returned upon completion of testing. “Please Return Samples” 

should be indicated on the packing slip. If NIOSH denies an application based upon documentation 

issues, the application, and in most cases, all hardware samples will be returned. 

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

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

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

charges. The applicant is responsible for all shipping costs and making all arrangements to clear the 

hardware samples through customs when shipping hardware samples to be used for testing to or from 

NIOSH.

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

deletions are permitted by the applicant once NIOSH receives the application.

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

requested.
8/4/2022 SCBA and CBRN SCBA

25

Saving the Application

Once the application form has been completed, save the data file by selecting FILE, then SAVE AS, from 

the menu bar on the main menu screen. 
8/4/2022 SCBA and CBRN SCBA

26

Section 3 Supplemental Information for Preparing a Self- 

 Contained Breathing Apparatus or CBRN 

 Self-Contained Breathing Apparatus Application

3.1 Quality Assurance Documentation

Understanding the requirements of 42 CFR Part 84 Subpart E and specific quality system characteristics 

as noted below are necessary to adequately develop and maintain Quality Assurance and quality control 

programs acceptable to NIOSH. Prior to obtaining any approvals under 42 CFR Part 84, all approval 

holders are required to have an approved Quality Assurance Manual on file at NIOSH. 

If an organization has an approved QA Manual and there is no change, complete the applicable blocks 

on the SAF. If a previously approved QA Manual is being revised, it is not necessary to submit the entire 

manual. In a separate QA application, submit only the sections that have been revised and an updated 

revision history sheet. 

3.2 Quality Assurance Manual

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

A. Statement of Quality Assurance.

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

- A revision history sheet showing date and reason for revision.

- A Table of Contents.

- Management assurance that the QA system meets NIOSH requirements in 42 CFR Part

84 Subpart E.

B. Description of Management Responsibilities as they relate to:

- The company quality policy.

- Personnel/organization structure necessary to carry out these provisions.

- Verification of quality (internal auditing).

- Quality system review.

- International Standards Organization (ISO) certification (if applicable).

C. Structure of Quality System.

- Identify how quality procedures and instructions are prepared and implemented.

D. Contract Review Activities (as applicable).

E. Design Control for aspects of safety, performance, and dependability of the product reliability

programs.

F. Control of All Documents and Data (control of engineering drawings, documentations, and

changes).

G. Quality in Purchasing.

H. Control of Customer-Supplied Product (control of purchased material to include incoming

inspection).

I. Product Identification and Traceability.
8/4/2022 SCBA and CBRN SCBA

27

J. Control of Production Processes (lot identification, control of processes, manufacturing,

fabrication, and assembly work conducted in the plant).

K. All Areas of Inspection and Testing: Receiving, In Process, and Final Inspection.

L. Control of Inspection, Measuring, and Test Equipment.

M. Inspection and Test Status.

N. Control of Nonconforming Product.

O. Corrective and Preventive Actions (as applicable).

P. Inventory and Handling Controls.

Q. Control of Quality Records.

R. Internal Quality Audits (audit of final inspection of the completed product).

S. Training.

T. Servicing (as applicable).

Note: If the manual does not incorporate the specific elements within the document, then the manual 

must link or list the Standard Operating Procedures (SOPs) for the various elements. 

3.3 Product Quality Control Plan and Documentation

Product Quality Control Plan (PQP) documentation is required to be submitted as part of an application 

to demonstrate to NIOSH the applicant’s process characteristics involved in controlling and monitoring 

the quality of the respirator being manufactured. 

Items that must be submitted are the:

A. PQP flowcharts showing all inspection and test operations. Identify each procedure by AAR#.

Inspection or test procedures clearly identified on the flow chart.

B. Sampling plan and classification of defects document as described in 42 CFR Section 84.41 (c),

(d), (e), (f), (g), and (h).

C. In process inspection and test procedures for items listed on the assembly matrix.

D. Final inspection and test procedures for the complete respirator and items listed on the assembly

matrix.

E. Simplified Self-Contained Breathing Apparatus respirator drawing.

F. Assembly matrix.
8/4/2022 SCBA and CBRN SCBA

28

3.4 Fees 

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

be made payable to NIOSH, dated less than 30 days prior to the submission date, and contain the AAR#. 

The specific AAR# for the application must be written on the check. Checks older than 30 days may be 

returned. Separate checks are required for each application submitted. Do not issue multiple 

application fees on one check. Otherwise, checks will be returned and application processing delayed.

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

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

the NIOSH NPPTL Records Room to facilitate linking the payment to the approval request. 

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

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

end of the Initial Review Phase. 

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

and the assigned tests. In the event other testing or other additional cost items are identified after the 

acceptance of the original estimate, the company will be contacted and an addendum to the estimate 

will be forwarded for acceptance.

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

During the Final Review Phase, an invoice for all fees, including testing of equipment, incurred in the 

processing of an application will be generated. Invoices will contain specific payment instructions and 

identify authorized methods of payment, and will be provided to the approval holder for payment. 

Respirator Approval Application-Based fees are as follows:

Administrative Fees:

Fee Type Legal Citation Amount Due Date

Application 42 CFR 

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

Upon receipt of any application 

request. To be submitted with 

application.

Approval 42 CFR 

§84.20(b)(1)

$100 per each certificate of approval 

issued. Upon receipt of the invoice. 

Approval 

Modification

42 CFR 

§84.20(b)(1)

$50 per each certificate of approval 

modified. Upon receipt of the invoice. 

Site 

Qualification

42 CFR 

§84.20(b)(3)

• Existing approval holder, paper review:

$400 per each request to inspect new

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. 
8/4/2022 SCBA and CBRN SCBA

29

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

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

the User Instructions are revised due to a change in a specific respirator, but the same User Instructions

are used on a family of respirators (example: family consists of 20 approvals), the approval modification 

fee of $50 will be charged for all the approvals under that family of respirators (20 X $50 = $1,000).

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

the invoice. The final letter (approval or denial) will be issued to the primary contact once all reviews 

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

3.5 Combination Supplied-Air Respirators and Self-Contained Breathing 

Apparatus, Self-Contained Breathing Apparatus, or CBRN SelfContained Breathing Apparatus Test Fees 

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

These apply only to Supplied-Air and Self-Contained Breathing Apparatus Respirators. 

Supplied-Air Testing Fees:

0100 Strength of Hose and Coupling, C and CE SAR $150.00

0101 Tightness of Hose and Couplings, C and CE, SAR $150.00

0102 Nonkinkability of Hose, C and CE, SAR $150.00

0103 Gasoline Permeability of Hose/Couplings, C and CE $450.00

0104 Regulator 100,000 Cycle Test, Demand/PD, C/CE $3,000.00

0105 Airflow Determination, CF, C and CE SAR $300.00

0105A Airflow Determination, Demand/PD, C and CE SAR $300.00

0106 Inhalation Airflow Resistance, PD, C and CE SAR $150.00

0107 Exhalation Airflow Resistance, PD, C and CE SAR $150.00

0108 Inhalation Airflow Resistance, Demand, C/CE SAR $150.00

0109 Exhalation Airflow Resistance, Demand, C/CE SAR $150.00

0110 Gas Tightness Test, IAA, C and CE SAR $450.00

0111 Sound Level in Hood or Helmet, C and CE SAR $450.00

0112 Protection Level, Abrasive Blast, CE, NaCl or Corn Oil $450.00

0113 Airflow Resistance, CF, C and CE SAR $150.00

0118 Low Temperature Operation SCBA $1,200.00

0119 Low Temp Operation, Combo SCBA and C/CE SAR $1,200.00

0120 Positive Pressure, SCBA $75.00

0121 Rated Service Time, SCBA, Demand and PD $75.00

0121A Rated Service Time, CCSCBA, Demand and PD $75.00

0122 Exhalation Resistance, SCBA, Demand and PD $150.00

0123 Gas Flow Measurement, SCBA, Demand and PD $150.00
8/4/2022 SCBA and CBRN SCBA

30

0124 Remaining Service Life Indicator, SCBA, Demand/PD $150.00

0124A Alarm Pressure, CCSCBA, Demand and PD $150.00

0125 Gas Tightness, IAA, SCBA, Facepiece and Mouthpiece $750.00

0125A Gas Tightness, IAA, SCBA, Hoods or Helmets $750.00

0126 Bypass Valve Flow, SCBA, Demand and PD $150.00

0128 Accuracy of Gauge, SCBA $150.00

0133 Exhalation Breathing Resistance, PD SCBA $150.00

0139 CO2 Facepiece Level Determination, SCBA $450.00

0140 Man Tests, SCBA $3,000.00

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

0147 Mode Transfer Test, SCBA/SAR $150.00

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

New Site Qualification Fee, Existing Manufacturer $400.00

Self-Contained Breathing Apparatus and Retrofit, CBRN:

0200 GB LAT1 $9,142.00

0201 HD LAT1 $9,142.00

0202 LRPL $20,000.00

0202 Partial LRPL $16,000.00

0200/0201 Aerosol Process TDA-99M (SMARTMAN) Only $600.00

Note: 1 Testing Performed at RDECOM. 

Test Fees to be Charged for New and Unspecified Tests:

Emergency Breathing Safety System (EBSS) 

testing for SCBA

$500/day for test, plus actual costs for test subjects 

and required medical coverage. 

$100/day per human test subject.

$1,300/day for medical staff.

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

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

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

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

specific application(s), add an -F after the TN number(s) (TN-nnnn-F). 

3.6 Annual (Fixed) Certification (Approval) Fees 

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

obsolete certificates of approval. Invoices will be sent in September with payment due by October 30 of 

the applicable year. Invoices will itemize the number of manufacturing sites and approvals and apply 

the fees per the following table: 
8/4/2022 SCBA and CBRN SCBA

31

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. 

Quality Assurance 

Maintenance 

(Site Audit) 

42 CFR 

§84.20(b)(4)

• Annual fee: $3,000 per every manufacturing

site registered with NIOSH. 

• Variable fee:2

▫ 1 day domestic audit - $2,500 per site.

▫ 2 day domestic audit - $5,000 per site.

▫ 1 day international audit - $7,500 per site.

▫ 2 day international audit - $10,000 per

site.

October 30 of applicable year. 

Maintenance of 

Testing and 

Approval Facilities

42 CFR

§84.20(b)(2)

$34 per every listed1 approval on file with 

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

Maintenance of 

Test Equipment

42 CFR 

§84.20(b)(2)

$36 per every active3 approval on file with 

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

1. “Listed” approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects the current listed 

approvals maintained by NIOSH.

2. Applies to design as well as manufacturing sites.

3. Does not include obsolete approvals.

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

and must reference the AAR# or TN or NIOSH invoice number. 
8/4/2022 SCBA and CBRN SCBA

32

3.7 Pay.Gov Instructions

Domestic applicants may use the electronic fees transfer program known as Pay.Gov.

Note: Prior to making any payment of respirator approval fees, applicants must establish an account 

with Pay.Gov. 

A. Follow the web link provided below:

a. PAY.GOV homepage: https://pay.gov/paygov/homepage.

B. On the center of the web page click on the link “Click here to register” to start the process or

go to the web page address provided below:

a. Registration: Pay.gov - Register for a Pay.gov Account.

b. Read the User Responsibility Statement, fill in the box, and select accept.

c. Select the “Continue with Self Enrollment” tab.

d. Complete the required fields in the Online Self Enrollment form and then select

“submit.”

e. Use Pay.Gov username and password to log into the Pay.Gov system from the

homepage.

f. Access the forms necessary to submit payments online using this process.

C. Fee Payment User Instructions.

a. Open the Pay.Gov homepage.

b. Locate the “User Fee Form.”

i. Go to the Find Public Forms section below the login.

ii. Search for forms by three options:

1. Form Name.

2. Agency Name.

3. Search Public Forms.

iii. Use one of three links listed on the six forms in the system for the Centers for

Disease Control and Prevention (CDC).

1. Form Name: CDC Royalty BMLA and User fee Form.

a. Select CDC User Fee Form.

2. Agency Name: CDC Royalty BMLA and User Fee Form.

a. Select CDC User Fee Form.

3. Search Forms: CDC Royalty BMLA and User Fee Form.

a. Select CDC User Fee Form.

4. Click on the form name to open the online fillable form.

iv. Complete the Online CDC User Fee Form.

1. Complete all mandatory blocks marked with asterisks.

2. Under CDC Invoice Number, enter the three digit Applicant-Assigned

Reference Number (AAR#).

a. If payment is for an existing Task Number (TN), enter the

associated TN.
8/4/2022 SCBA and CBRN SCBA

33

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

choices.

4. Enter a short description in the comments block regarding the

payment. Add any specific identifying information regarding the

submission that may help in processing the payment.

c. When submitting the form, users will be prompted to enter their Automated Clearing

House (ACH) debit information.

D. Currently Pay.Gov accepts payment directly by the Automated Clearing House (ACH) feature

or through credit or debit cards as follows:

a. Credit Cards: Visa, MasterCard, American Express, and Discover.

b. Debit Cards: Visa and MasterCard processed only.

Note: More in-depth instructions and information can be found at Pay.Gov homepage. 
8/4/2022 SCBA and CBRN SCBA

34

3.8 Drawings for Self-Contained Breathing Apparatus or CBRN Self- 

 Contained Breathing Apparatus 

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

Draw, and Corel Draw. Drawings should be named using a unique identifier of the organization’s choice, 

R for drawing, the revision level (e.g., a, b, c, etc.), and the file extension representing the software 

program (e.g., nnnnRa.dwg). All engineering and CAD drawings must be saved and submitted in full 

view mode. All engineering and CAD drawings must be submitted in black and white. The signature 

blocks on each submitted drawing must contain the initials or signature of the preparer and approver 

along with the approval date for the drawing revision. 

3.8.1 Exploded-View Drawing and Major Subassembly Drawing for a SCBA or 

 a CBRN SCBA

For Self-Contained Breathing Apparatus, the exploded-view drawing is the major subassembly drawing 

and must include the complete respirator with critical or major dimensions, materials, and 

characteristics as listed on the Self-Contained Breathing Apparatus drawing checklist. User Instructions

do not need to be illustrated on the exploded-view drawing. Do not include future submittals or 

unapproved assemblies on the exploded-view drawing. 

Use an identifying numbering system of the major subassemblies on the exploded-view drawing to 

reference major subassemblies from the assembly matrix to the exploded-view drawing. The identifying 

numbering system on the major subassemblies must match exactly with the assembly matrix.

If a facepiece is shown as item 1 on the assembly matrix, it must also be item 1 on the exploded-view 

drawing. The applicant may use dotted lines around subassemblies on an exploded-view drawing to 

group the smaller parts together into one major subassembly. If the profile of a component changes, 

i.e., from a facepiece to a facepiece with a side window, the components must be shown separately as

1a, 1b, 1c, etc.
8/4/2022 SCBA and CBRN SCBA

35

3.8.2 Example of an Exploded-View Drawing for a SCBA or a CBRN SCBA

3.8.3 Major Subassembly Drawing for a SCBA or a CBRN SCBA

Applicants must submit major subassembly drawings for each major subassembly shown on the 

exploded-view drawing. If a major subassembly is unchanged from a previous submittal and the 

drawing is already on file at NIOSH, the drawing does not have to be resubmitted. The major 

subassembly drawings may not contain future submissions or show unapproved assemblies. 

All major subassembly drawings must meet the requirements defined in the “Major Subassembly

Drawing Checklists” found in Section 6. All drawings must be under the approval holder’s control and in 

compliance with the document control system. Major subassembly drawing numbers and revision levels 

must match exactly with those found on the assembly matrix.

DWM
8/4/2022 SCBA and CBRN SCBA

36

Major subassemblies must have permanent identifying part numbers marked on them. This part 

number must appear in the part number row of the assembly matrix. The part number location must be 

clearly shown on the major subassembly drawings.

3.8.4 Material Specifications on Drawings for a SCBA or a CBRN SCBA

For material specifications, use the criteria affecting performance or design. 

For example, if an accessory would not affect the performance or design, materials could be identified 

as plastic, metal, rubber, etc. However, if the items do affect performance or design, they would be 

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

3.9 Component Vendors

If the applicant controls all specifications for the component, the component vendors do not need to be 

specified. If the applicant does not control all specifications of the component, then the applicant must 

provide the name of the vendor. In accordance with 42 CFR Sections 84.42 (c) and 84.43 (c) the 

approval holder is obligated to manufacture in accordance with the approved documentation. NIOSH 

reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's 

quality control test methods, equipment, or records do not ensure effective quality control over the 

respirator for which the approval was issued. See the April 7, 2005 Letter to All Manufacturers on 

“Clarification of Supplier and Subcontractor Relationships" for additional information.

3.10 Assembly Matrix

• An assembly matrix is a diagram of major subassemblies and accessories. It must be submitted

electronically in Microsoft Excel 97 (or later) format and it must be formatted as shown in the

example. The assembly matrix cannot be part of the exploded-view drawing.

• An “X” placed in the wrong box on a label or assembly matrix could delay the approval process.

Please verify the placement.

• Only one assembly matrix is necessary for a series of applications involving a common assembly

matrix. This assembly matrix must be submitted with the last application in the series.

• The AAR# for the application that contains the assembly matrix must be identified in the

Approval History section of each application in the series.

• When a new TC number is being requested, identify the rows for the new TC number using the

numbering convention of “schedule#, AAR#, alpha character” in the TC number column. For

example, for a Self-Contained Breathing Apparatus where the schedule# is 13F, followed by the

AAR# MOR699, and the TC number cell for the first row (a) of the new approval, the numbering

convention would be 13F-MOR699a. The second row would be numbered 13F-MOR699b, the

third row would be numbered 13F-MOR699c, etc.

• “TC-”can only appear in the column heading; do not use “TC-” in the assembly matrix row.

• Features that describe the respirator cannot be listed on the assembly matrix as a separate

column.

• Features associated with specific model numbers may be coupled together in the description

column heading (e.g., Model 1201-EZ Flow, Model 1202-EZ Flow, etc.).
8/4/2022 SCBA and CBRN SCBA

37

• The listing of User Instructions on Self-Contained Breathing Apparatus assembly matrices is

mandatory.

• More than one assembly matrix may be submitted with an application, if relevant.

• Columns with new information or revised information may be lightly shaded.

• Future submissions or unapproved assemblies should not be shown on the assembly matrices.

• Blank cells need to be entirely blank. The cells should not contain any unnecessary information,

spaces, embedded characters, hidden rows or columns, etc.

• The complete respirator or the respirator components listed on the assembly matrix must exactly

match those illustrated on the exploded-view drawing.

Some components may be an accessory on one approval and a required component on another. If a 

component is an accessory, this must be explained in the “Reason for Application.” If this information is 

not clearly stated, NIOSH will consider the component as required. The assembly matrix must list all 

major subassemblies and accessories. The NIOSH evaluation status for each component or subassembly

must be indicated as follows:

X = An existing component or respirator that has been previously tested and 

approved by NIOSH in this configuration. 

N = A new component or respirator. If a new TC number has been requested, “N” must 

appear in every column across the entire row. If an Extension of Approval is requested, 

“N” should only appear in columns for respirators or components new to the approval.

P = Pending. A component or respirator submitted in an earlier application that is currently 

being evaluated by NIOSH.

R = A redesign or revision to an existing component or respirator where the part number has 

not changed. “R” is to be used indicating a change to any associated document with that 

component.

- = A component or respirator designated by the approval holder as obsolete. Do not use 

“double dash.” An obsolete item must be shown on the matrix as obsolete for the TC 

number/part number combination at least once. Once organizations have submitted an 

assembly matrix with obsolete items, they may drop these items from the matrix in 

future submissions. If obsoleting an approval, dash marks must appear in every block 

that a component for that approval was marked. 

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

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

used or not. 

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

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

reconsider whether an application for approval is required. If in doubt, call NIOSH NPPTL Conformity 

Verification and Standards Development Branch at (412) 386-4000.
8/4/2022 SCBA and CBRN SCBA

38

3.11 Approval Labels and Private Labels

Approval labels used in User Instructions, on packaging, or on devices must be legible. Labeling 

requirements vary based on the type and intended use of the respirator. See example label formats for 

Self-Contained Breathing Apparatus. The list of protections must be in the same order and identical to 

the matrix. Submit draft versions of the appropriate labels. 

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

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

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

with the location of the Health and Human Services (HHS) and NIOSH logos noted. Logos are available 

on the NIOSH NPPTL homepage. The applicant is responsible for inserting the logos during label 

production. Approval Labels may not contain future submittals or show unapproved assemblies.

3.12 List of NIOSH Cautions and Limitations for Self- Contained Breathing 

Apparatus or CBRN Self-Contained Breathing Apparatus 

SAR (Airline): A*, B, C, D, E, I*, J, K*, M, N, O, S*

SCBA: I*, J, M, N, O, S

CBRN SCER: I*, J, M, N, O, S*, R, X, AA, BB, DD, EE, JJ, GG, II, NN

CBRN SCBA: I*, J, M, N, O, S, Q, R, T, U 

* Notes:

A For an SAR, this is not needed if the unit is equipped with an escape bottle. 

I Applies if the respirator contains electrical components and the intrinsic safety has not

been evaluated and approved by MSHA or a recognized independent laboratory.

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

private label version.

AA Depending on use or design such as a mouthbit. 

LL If protection varies depending on assembled configuration. 

Closed-Circuit SCBA: An “S” will be assigned to all units referring users to the Special section

in the User Instructions. The User Instructions are to call out the following listed in Federal

Register Notice Volume 50. No. 222 published 11/18/85:

Limitations:

- Do not use this apparatus where there is direct exposure to flames or in high

radiant heat (this limitations applies to 100 percent oxygen apparatus only).

- Provide proper care, training and maintenance of the apparatus as specifically

described in the manufacturer’s instructions and maintenance manuals.

- After each use of this apparatus, a fully charged breathing gas container and a recharge of

carbon dioxide scrubber will be installed.

- Thorough cleaning and disinfecting of facepiece, breathing tube, and breathing

bag must be done in accordance with manufacturer’s instructions.
8/4/2022 SCBA and CBRN SCBA

39

Cautions:

- Keep exposed hair to a minimum when using apparatus near open flames or in radiant

heat.

- A good facepiece seal is important since facepiece leakage will seriously reduce service

time.

- Use of pure oxygen or oxygen enriched air increases flammability and lowers the ignition

temperature of most materials.

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

If the respirator contains electrical components and the applicant wishes to list the respirator on the 

NIOSH approval label as intrinsically safe, obtain intrinsic safety approval from the MSHA under Title 30 

CFR Part 18 or other recognized independent laboratory and submit verification of such approval in the 

application. If the respirator is for underground use, MSHA intrinsic safety must be received prior to 

submitting for NIOSH approval.

Combination units usually require all cautions and limitations from either type.

3.13 Private Labeling Versus Private Packaging 

Private Labeling

Approval Holder A enters into an agreement to allow Company B to sell Approval Holder A’s respirator 

as being manufactured by Company B. All packaging, labeling, markings, User Instructions, and 

literature should indicate Company B. This approach appears to the user that the approval holder of the 

respirator is Company B. The only reference to the actual approval holder is in a Special Instructions S 

section. The respirator name, model number, and part number may or may not be the same as what is

used by Approval Holder A. The NIOSH TC number will not be changed. Approval Holder A remains 

responsible for the respirator quality and all packaging, labeling, markings, and literature pertaining to 

the NIOSH approval. Approval Holder A must ensure that the private labeler does not misrepresent the 

NIOSH approval. Private labeling is always submitted to NIOSH by the approval holder for approval.

An Extension of Approval Application, submitted by the approval holder, is necessary for all private label 

requests. If a part number or model number changes, the Extension of Approval Application must be 

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

A Special Cautions and Limitation “S” is to be added to the private label approval label. 

A specific section titled “S-Special Instructions Section” is to be added to the private label User 

Instructions as follows:

The model/part number “respirator type” has been manufactured by Company (Approval Holder 

A) for private label Company B under TC-XXY-nnnn.

Private Packaging

Approval Holder A enters into an agreement to have its respirators sold by Company B. Company B puts 

the assembled respirator in a different or additional package. The respirator name, model number, part 

number, respirator labeling, markings, User Instructions, and literature show Approval Holder A as the 
8/4/2022 SCBA and CBRN SCBA

40

approval holder. The packaging may represent Company B and its catalog or other reference number. 

However, this packaging must be done in a manner which does not mislead the user to think Company B 

is the approval holder. Clarifiers, such as “Sold by Company B and Manufactured by Approval Holder A” 

or “Made by Approval Holder A for Company B” must be included on the packaging. The NIOSH 

approval label will not be changed. Approval Holder A remains responsible for respirator quality and all 

packaging, labeling, markings, and literature that pertains to the NIOSH approval. Approval Holder A 

must ensure that the private packager does not misrepresent the NIOSH approval. NIOSH does not need 

to be notified of private packaging arrangements (no application needs to be submitted).

Note: Private packaging does not result in any changes to NIOSH documentation on file for the 

approved respirator configuration. User Instructions and NIOSH approval labels provided on or with the 

package must not be changed. Approval labels and the package artwork are part of the NIOSH 

documentation and therefore must not be changed to remain a private packaging arrangement. 

For both private labeling and private packaging arrangements, the approval holder is responsible for 

notifying the private label or private package company of any changes in approval status, such as stop 

sale, rescission, or revocation.

3.14 User Instructions

User Instructions must be submitted to NIOSH for Self-Contained Breathing Apparatus. User 

Instructions must be listed on the assembly matrix for Self-Contained Breathing Apparatus, and are 

required. An Extension of Approval Application is required for changes to the User Instructions. User 

Instructions and associated procedures such as maintenance requirements, inspection procedures, and 

donning and doffing instructions that pertain to the respirator submitted for approval must be 

submitted as a complete package. When there is a change, NIOSH will not accept only the amended 

pages. A complete User Instructions document must be submitted indicating what has been changed 

either by highlighting the changed items or a cover page listing the page numbers and detailing 

paragraphs updated. The file description for the User Instructions must clearly and specifically identify 

the model or product line and revision level. Bold, underline, or otherwise indicate all changes to the 

User Instructions from the prior revision level. 

When an approval has a design or performance issue, corrections to the User Instructions is not 

adequate to address the issue

For Caution and Limitation “S”, Special or Critical User Instructions, noted on the approval label and 

listed in the User Instructions: 

• Approval holders have discretion in what is identified as special cautions or limitations. To be

“special” the specific attribute of the respirator must go beyond the standard cautions and

limitations and be unique or unusual for the class of respirator.

• If the approval holder states “Special or Critical User Instructions or specific use limitations

apply,” the Special or Critical User Instructions must be readily identified within a separate

section of the User Instructions with the heading, “S - Special or Critical User Instructions.”

• Examples of special or critical instructions are special donning procedures, service life limitations,

and private labeled respirators.
8/4/2022 SCBA and CBRN SCBA

41

For private label respirators, the S-Special or Critical User Instructions section in the private label 

holder’s User Instructions will state:

“The model/part number “respirator type” has been manufactured by Approval Holder A 

(Company) for private label Company B under TC-13F-nnnn.” 

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

to ensure the items are correct and appropriate.

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

and Health Administration (OSHA) reference must be included in the User Instructions under a Special 

“S” titled listing: 

Before occupational use of this respirator, a written respiratory protection program must be 

implemented meeting all the local government requirements. In the United States, employers 

must comply with OSHA 29 CFR 1910.134 which includes medical evaluation, training, and fit 

testing.

Requirements Specific to Self-Contained Breathing Apparatus 

The approval label may be located on the container or box or inserted in the package or in the User 

Instructions. 

The location of the approval label and User Instructions within the final packaging arrangement, are to 

be stated either on the respirator drawing or as an attachment to these documents. Packaging artwork 

is not required, but will be accepted as fulfillment of this requirement.

3.15 Packaging Art Work and Carton Design

In accordance with 42 CFR Section 84.33, the applicant will submit full scale reproductions of approval 

labels and markings, and a sketch or description of the method of application and position on the 

harness, container, canister, cartridge, filter, or other component, together with the instructions for use 

and maintenance of the respirator. 

Approval labels will include the HHS and NIOSH logos, the applicant's name and address, the approval 

number assigned by NIOSH, and, where appropriate, restrictions or limitations on use of the respirator.

When additional labels, markings, or instructions are required, the applicant will be notified. 

Approval labels and markings will only be used by the applicant to whom the labels were issued.

Legible reproductions or abbreviated forms of the label approved by NIOSH for use on each respirator 

will be attached to or printed on the following locations:

Respirator type Label type Location
8/4/2022 SCBA and CBRN SCBA

42

Self-Contained Breathing 

Apparatus

Entire Harness assembly and canister (where applicable).

Supplied-Air Respirator Entire Respirator container or instruction card.

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

and test the respirator as it stated in the documentation as approved by NIOSH. The company will 

maintain the PQP, as submitted and approved, and will not deviate from this plan. The plan will only be 

changed after the company submits a request to NIOSH and this plan change is reviewed and approved 

by NIOSH. 

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

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

and the name and letters or numbers by which the respirator or respirator component is designated for 

trade purposes, and the lot number, serial number, or approximate date of manufacture.

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

Package advertising that is not permitted includes phrases such as:

“NIOSH-Approved Tactical SCBA”

Packaging may include a phrase such as: “NIOSH-Approved CBRN SCBA; recommended by the approval 

holder for use in SWAT operations.” 

3.16 Summary of Related Documents

Provide a complete and accurate listing of all new or revised files that pertain to the application. Give a 

specific filename to each controlled document submitted with the application. The summary of related 

documents must precisely match the electronic files submitted. Applications may be returned without 

being processed if the summary is incorrect. 

The following information must be included:

Filename: 

XXX represents the three character NIOSH-Assigned manufacturer’s code and should only appear 

on the application. 

nnnn represents the unique characters chosen by the applicant.

The filename with extension must be listed, using Specific file naming conventions.

Spaces must not be used in filenames. 

Filenames are derived from the controlled document number, not the AAR#. 

For example, the filename for drawing 10222 revision A should be 10222Ra.dwg. 

For future submissions of the same document, the only change to the filename will be to the 

revision level; the next submission of the drawing above would be 10222Rb.dwg. 

Files submitted using the AAR# as filenames will be returned.
8/4/2022 SCBA and CBRN SCBA

43

Document Type:

Pretest data, drawing, assembly matrix, draft approval label, QA Manual, PQP, service life plan, 

User Instructions, etc.

Description: 

Detailed description giving specific information identifying model name or number, revision level, 

drawing number, and title.

Software program extension: 

The software program (including version) used to create the file. 

nnnn= unique identifying characters. 

a, b, c, etc. = revisions. 

.pdf, .xml, .xls, etc. = program used to create file. 

In addition to the application file, the manufacturer must submit related project documents. These documents 

must be in English and saved with the following file-naming conventions. Any files created in a language other 

than English will be returned unprocessed.

3.17 File Naming Conventions

Required Documents Naming Convention 

Abbreviation

Acceptable Software 

Packages File Naming Convention Format

Application Form - 

Microsoft Access

Java

Adobe Acrobat

XXXnnnn.MDB

XXXnnnn.xml

XXXnnnn.PDF

Pretest Data PD

Adobe Acrobat

Excel

Microsoft Word

nnnnPD.PDF

nnnnPD.XLS

nnnnPD.XLSX

nnnnPD.DOC

nnnnPD.DOCX

Drawings R followed by revision 

level (if applicable)

Adobe Acrobat

AutoCAD 

Scanned file

nnnnRa.PDF

nnnnRb.DWG

nnnnRc.TIF

nnnnRd.GIF

nnnnRe.JPG

nnnnRf.BMP

(a-f indicate various revision levels)

Assembly Matrix AM followed by revision 

level (if applicable) Excel nnnnAMa.XLS

nnnnAMb.XLSX

Draft approval labels DL followed by revision 

level (if applicable) Excel nnnnnDLa.XLS

nnnnDLb.XLSX

Quality Assurance 

(QA) Manual

QM followed by revision 

level (if applicable)

Adobe Acrobat

Scanned file

Excel

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)
8/4/2022 SCBA and CBRN SCBA

44

Product Quality 

Control Plan (PQP)

PQP followed by revision 

level (if applicable)

Adobe Acrobat

Scanned file

AutoCAD 

Excel

Microsoft Word

nnnnPQP.PDF

nnnnPQP.TIF

nnnnPQP.DWG

nnnnPQP.XLS

nnnnPQP.XLSX

nnnnPQP.DOC

nnnnPQP.DOCX

Fees - Paper or PAY.GOV only Paper or PAY.GOV only

Service Life Plan

(If Required)

SLP followed by revision 

level (if applicable)

Adobe Acrobat

Scanned file

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)

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

working file contained in the zipped file.

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

by name.

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

original files.

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

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

files posted to the project.

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

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

single filename will not be accepted and the application may be denied.
8/4/2022 SCBA and CBRN SCBA

45

Section 4 Approvals and Denials

4.1 Approval Documentation

If the respirator complies with all of the requirements outlined in these procedures and 42 CFR Part 84, 

NIOSH will grant an approval and assign a TC number. 

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

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

final approval label files, if applicable, with the appropriate approval documentation. Applicants may 

use consultants or authorized representatives as contacts for the application. These contacts may 

submit applications either by request of the company primary contact or in place of the company 

primary contact. Foreign companies may provide a U.S. contact as a consultant or authorized 

representative. For applicants using consultants or authorized representatives, the final letter of 

approval and enclosed documentation will be sent directly to the applicant with a copy of the approval 

letter to the consultant or authorized representative. All approval documentation and application 

discussions will still be done through the company primary contact.

When application approval labels and assembly matrices contain rows of information for approvals 

other than the ones evaluated in the individual application under review, approval letters will indicate 

that only the approvals indicated (or marked requested) under the individual application are granted. 

4.2 Denial Documentation

If the respirator fails to meet the requirements of 42 CFR Part 84, the application will be denied and all 

documentation, CD-Rs or DVD-Rs, and test samples (hardware) will be returned or destroyed. NIOSH 

will not retain documentation or test samples (hardware) for any respirator that has failed to meet all of 

the requirements. If NIOSH denies an application based upon documentation issues, the application, 

CD-Rs or DVD-Rs, and all sample hardware will be returned to the applicant’s U.S. or Canadian address

or authorized representative. It is recommended that foreign applicants have and use their U.S.

representative’s address on return shipping labels.

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

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

documentation and the reason for failure must be addressed.

4.3 Denial Prior to Assignment of a Task Number

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

include: 

• An application is assigned a previously used AAR#.

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

pretest data, User Instructions, or drawing package is missing, is in an unacceptable file format,

or uses an unacceptable file naming convention.

• Test samples (hardware), application package, and payment are not received within two weeks

of one another.
8/4/2022 SCBA and CBRN SCBA

46

• Shipping boxes contain sample test (hardware) associated with different applications and

without separate packaging to indicate what sample hardware goes with each application.

• Packages of sample test (hardware) received within the same box are not clearly labeled.

• An assembly matrix is not associated with every application (except QA Applications).

• A complete file list is not included in the related documents section of the application.

4.4 Denial of a Project Undergoing NIOSH Evaluation

Some of the reasons why applications may be denied after issuance of a TN include:

• Assembly matrix, exploded-view drawing, approval labels, or major subassembly drawings are

incorrect (content or format) or show unapproved assemblies.

• Pre-submission test data is not complete. For example, it does not include total resistance on

the complete assembly or all assemblies involved in the submittal(s).

• Sample hardware submitted does not match subassembly drawings, part numbers, or the

assembly matrix drawing.

• Drawings are not in accordance with the documentation control procedures stated in the

applicant’s Quality Assurance Manual.

• Additional information requested by NIOSH is not received within two weeks of the date

requested.

• The application is for a new or unique respirator which cannot be approved under current

regulations for which there is no existing NIOSH policy (e.g., smoke hoods, SAR with pneumatic

tools, etc.).

• Applicant’s pre-submission test data indicates that the respirator would fail the NIOSH regulatory

test requirements or the appropriate pretest data is not submitted with the application.

• The official submittal either (1) requested approval of two respirators of different basic designs

(includes submitting a SCBA unit for entry and escape and an alternate unit for escape-only in the

same application) or (2) requested a new approval and an extension of approval action in the

same application.

• The Standard Application Form (SAF) has errors, deficiencies, or is incorrect.

• Items on the assembly matrix do not correspond exactly to the “Reason for Application,” drawing

revision levels are wrong, components on the exploded-view drawing are improperly numbered,

or documents are otherwise incorrect.

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

from other governing agencies (such as MSHA for mine use with MSHA intrinsic safety or intrinsic

safety from recognized laboratories).

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

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

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

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

4.5 Respirator Certification (Approval) Program Decision Review Process 

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

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

ongoing respirator approval activities.
8/4/2022 SCBA and CBRN SCBA

47

Section 5 Test Selection Guide for Self-Contained Breathing 

Apparatus and CBRN Self-Contained 

Breathing Apparatus 

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

7 SCBA - open-circuit, 

entry, demand

 Subpart H

TEB-APR-STP-0004

Determination of Exhalation 

Valve Leakage

2 complete units plus one each of 

all accessories

 3 cylinder gauges,

 3 remote gauges, as required

RCT-ASR-STP-0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0124

Determination of Remaining 

Service-Life Indicator - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP-0126

Determination of Bypass 

Valve Flow - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus
8/4/2022 SCBA and CBRN SCBA

48

RCT-ASR-STP-0145

Determination of Sound Level 

Measurements for Remaining 

Service Life Indicators - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0146

Determination of Diaphragm 

Over Pressurization - Open 

Circuit, Self-Contained 

Breathing Apparatus with Belt 

Mounted Regulators and 

Breathing Tubes

RCT-ASR-STP-0148

Determination of Remote 

Gauge Leak-Flow Test - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0155

Man Test Number 6 - SelfContained Breathing 

Apparatus Using Liquefied

Gas

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

8 SCBA - open-circuit, 

entry, pressuredemand

RCT-ASR-STP-0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

 2 complete units plus one each of 

all accessories

 3 cylinder gauges

 3 remote gauges, as required

RCT-ASR-STP-0120

Determination of Positive 

Pressure - Open-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0124

Determination of Remaining 

Service Life Indicator - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces
8/4/2022 SCBA and CBRN SCBA

49

RCT-ASR-STP-0126

Determination of Bypass 

Valve Flow - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0145

Determination of Sound Level 

Measurements for Remaining 

Service-Life Indicators - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0146

Determination of Diaphragm 

Over Pressurization - Open 

Circuit, Self-Contained 

Breathing Apparatus with Belt 

Mounted Regulators and 

Breathing Tubes

RCT-ASR-STP-0148

Determination of Remote 

Gauge Leak-Flow Test - OpenCircuit, Demand And 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0155

Man Test Number 6 - SelfContained Breathing 

Apparatus Using Liquefied

Gas

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

9 SCBA - closed-circuit, 

entry

RCT-ASR-STP-0117

Determination of Positive 

Pressure - Closed-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus

2 complete units, plus one each of 

all accessories

 21 scrubbers or 02

generating canisters

or

 21 fully charged 02

cylinders

plus

 1 breathing bag

 1 relief valve override tool (if 

needed)

 3 cylinder gauges

 3 remote gauges (if needed)

RCT-ASR-STP-0121A

Determination of Rated 

Service Time - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0124A

Determination of Alarm 

Pressure - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP-0127

Determination of Bypass 

Valve Flow - Closed-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus
8/4/2022 SCBA and CBRN SCBA

50

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0134

Determination of Gasoline 

Permeation Test on Breathing 

Bags - Closed-Circuit, Self-

Contained Breathing 

Apparatus

RCT-ASR-STP-0135

Determination of Inhalation 

and Exhalation Breathing 

Resistance - Closed-Circuit, 

Demand and Pressure-

Demand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0136

Determination of Demand 

Gas Flow - Closed-Circuit, 

Demand and Pressure-

Demand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0137

Determination of Continuous 

Gas Flow on Constant Flow 

with Demand Flow - Closed-

Circuit, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0138

Determination of Safety Relief 

Valve Operation - Closed-

Circuit, Demand and 

Pressure-Demand, Self-

Contained Breathing 

Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - Self-

Contained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0141

Man Test Number 5 - Closed-

Circuit, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0142

Determination of Vibration 

(Ro-Tap Test) For Man Test 

Number 1 - Escape, Closed-

Circuit, Demand, Self-

Contained Breathing 

Apparatus

RCT-ASR-STP-0143

Determination of Low-

Temperature Operation - 

Minimum per Manufacturer - 

Closed-Circuit, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0144

Determination of Continuous 

Gas Flow on Constant Flow - 

Closed-Circuit, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0145

Determination of Sound Level 

Measurements for Remaining 

Service Life Indicators - Self-

Contained Breathing 

Apparatus

RCT-ASR-STP-0146

Determination of Diaphragm 

Over-Pressurization - Open 

Circuit, Self-Contained 

Breathing Apparatus with Belt 

Mounted Regulators and 

Breathing Tubes
8/4/2022 SCBA and CBRN SCBA

51

RCT-ASR-STP-0148A

Determination of Remote 

Gauge Leak-Flow Test - 

Closed-Circuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0155

Man Test Number 6 - SelfContained Breathing 

Apparatus Using Liquefied

Gas

NOTE: Rated service time is tested during Man test 4, 

assuming that all previous Man tests have been 

satisfactorily completed.

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

11 SCBA - open-circuit 

escape, demand

RCT-ASR-STP-0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

2 complete units plus one each of 

all accessories

3 cylinder gauges

RCT-ASR-STP-0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0122

Determination of Exhalation 

Breathing Resistance - OpenCircuit, Demand and 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0125

Determination of Gas 

Tightness - Isoamyl Acetate, 

(IAA) - Self-Contained 

Breathing Apparatus with 

Facepieces and Mouthpieces

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed
8/4/2022 SCBA and CBRN SCBA

52

12 SCBA - open-circuit 

escape, pressuredemand

RCT-ASR-STP-0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

 2 complete units plus one each of 

all accessories 

 3 cylinder gauges

RCT-ASR-STP-0120

Determination of Positive 

Pressure - Open-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0121

Determination of Rated 

Service Time - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0123

Determination of Gas Flow 

Measurements - Open-Circuit, 

Demand and PressureDemand, Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0125

Determination of Gas 

Tightness - Isoamyl Acetate, - 

Self-Contained Breathing 

Apparatus with Facepieces 

and Mouthpieces

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

13 SCBA - open-circuit 

escape, constant 

flow

RCT-ASR-STP-0114

Determination of Sound Level 

Measurement - Escape, OpenCircuit, Self-Contained 

Breathing Apparatus Using 

Hoods or Helmets

 3 complete units

RCT-ASR-STP-0115 

Determination of Rated 

Service Time – Constant Flow, 

Escape, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0116 

Determination of Airflow 

Resistance - Continuous-Flow, 

Escape, Open-Circuit, SelfContained Breathing 

Apparatus With Hoods

RCT-ASR-STP-0118

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Open-Circuit, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0125A

Determination of Gas 

Tightness - Isoamyl Acetate, - 

Self-Contained Breathing 

Apparatus with Hoods or 

Helmets
8/4/2022 SCBA and CBRN SCBA

53

RCT-ASR-STP-0128

Determination of Accuracy of 

Gauge - Self-Contained 

Breathing Apparatus

RCT-ASR-STP-0132

Determination of Inhalation 

Breathing Resistance - OpenCircuit, Demand, SelfContained Breathing 

Apparatus

RCT-ASR-STP-0139

Determination of Facepiece 

Carbon Dioxide 

Concentrations - SelfContained Breathing 

Apparatus

RCT-ASR-STP-0140

Man Tests - Self-Contained 

Breathing Apparatus

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

14 SA Type C-CE,

 demand

 Subpart J

TEB-APR-STP-0004

Determination of Exhalation 

Valve Leakage

2 complete units plus one each of 

all accessories

All combinations of the maximum 

length of hose made up from the 

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 Pressure-Demand, 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, - Type C, and CE, 

Supplied-Air Respirators

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

respirators, perform all above tests plus 
8/4/2022 SCBA and CBRN SCBA

54

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

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 Pressure-Demand, 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 - PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0107

Determination of Exhalation 

Airflow Resistance - PressureDemand, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0110

Determination of GasTightness Test - Isoamyl 

Acetate, - Type C, and CE, 

Supplied-Air Respirators

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

respirators, perform all above tests

plus 

RCT-ASR-STP-0112

Determination of the Level of 

Protection Provided by 

Abrasive Blast, Type CE, 

Supplied-Air Respirators Using 

a Challenge Aerosol of NaCl 

(Sodium Chloride) or Corn Oil

* Actual tests selected may vary depending on design 

and intended use.
8/4/2022 SCBA and CBRN SCBA

55

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

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, - Type C, and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0111

Determination of Air Velocity 

and Noise Levels - Sound 

Level, Type C and CE, 

Supplied-Air Respirators

RCT-ASR-STP-0113

Determination of Airflow 

Resistance - Continuous-Flow, 

Type C and CE, Supplied-Air 

Respirators

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

respirators, perform all above tests

plus

RCT-ASR-STP-0112

Determination of the Level of 

Protection Provided by 

Abrasive Blast, Type CE, 

Supplied-Air Respirators Using 

a Challenge Aerosol of NaCl 

(Sodium Chloride) or Corn Oil

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

18 Combinations of any 

respirators in this 

guide

All tests for each category as appropriate

plus

All samples for each category as 

appropriate

For combination SCBA/SAR:

RCT-ASR-STP-0119 

Determination of Low 

Temperature Operation - 

Minimum Temperature per 

Applicant, Combination, 

Open-Circuit, Self-Contained 

Breathing Apparatus and Type 

C, and CE, Supplied-Air 

Respirators
8/4/2022 SCBA and CBRN SCBA

56

RCT-ASR-STP-0147 

Determination of Mode 

Transfer Test - Combination, 

Open-Circuit, Self-Contained 

Breathing Apparatus and 

Supplied-Air Respirators 

(SCBA/SAR)

For Combination SAR/AP:

RCT-APR-STP-0014

Determination of Leakage Of 

Drinking Tube and 

Accessories for Respirator 

Facepieces

* Actual tests selected may vary depending on design 

and intended use.

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

23 CBRN SCBA, OpenCircuit (CBRN SCBA) 

(Must be in 

conjunction with Part 

84 testing and 

NFPA/SEI 1981 

submittal)

RCT-CBRN-STP-0200, 

0201 

Determination of OpenCircuit, Self-Contained 

Breathing Apparatus (SCBA) 

Performance During Dynamic 

Testing Against Chemical 

Agents of Sarin (GB) Vapor 

and Distilled Sulfur Mustard 

(HD) Vapor and Liquid

GB LAT +

HD LAT +

2 SCBA units, low pressure without 

cylinder, live agent testing

4 SCBA units, high pressure, 

without cylinder, live agent testing

2 spare SCBA unit for live agent 

testing without cylinder

48 Facepieces with P100 filters 

configured in the air-purifying 

mode for LRPL

2 SCBA units per pressure for 

Emergency Breathing Safety 

Systems (EBSS) testing

202 Contact NIOSH NPPTL for STP

Draft test procedure in place, but 

final STP has not been published. 

Contact NIOSH NPPTL for more 

information at 412-386-4000.

TEB-CBRN-ASR-STP0219

Determination of OpenCircuit, Self-Contained 

Breathing Apparatus, 

Emergency Breathing Safety 

Systems (EBSS) Functionality 

During Low Temperature 

Operation

TEB-CBRN-ASR-STP0220

Determination of Positive 

Pressure - Open-Circuit, 

Pressure-Demand, SelfContained Breathing 

Apparatus During Emergency 

Breathing Safety System, 

Full-Flow Operation

+Tests performed at RDECOM 

* Actual tests selected may vary depending on design 

and intended use

Item

Respirator 

Type *NIOSH Test # Title Total Materials Needed

24 CBRN SCERs

TEB-APR-STP-0003

Determination of Exhalation 

Resistance

4 complete respirators without 

cylinders for live agent testing 

qualification

6 complete respirators without 

cylinders for live agent testing 

after environmental conditioning

115 complete respirators for 

bench testing minimum

TEB-APR-STP-0004

Determination of Exhalation 

Valve Leakage

TEB-APR-STP-0007

Determination of Inhalation 

Resistance

RCT-APR-STP-0064

Determination of Facepiece 

Carbon-Dioxide and Oxygen 

Concentration Levels - TightFitting, Powered Air-Purifying 

Respirators, With the Blower 

Unit Off
8/4/2022 SCBA and CBRN SCBA

57

CET-APRS-STP-CBRN0312

Determination of Field of 

View for Full Facepiece 

Chemical, Biological, 

Radiological, and Nuclear 

Respiratory Protective 

Devices 

CET-APRS-STP-CBRN0411

Laboratory Durability 

Conditioning Process for 

Environmental, 

Transportation and Rough 

Handling Use Conditions on 

Chemical, Biological,

Radiological and Nuclear AirPurifying or Self-Contained) 

Escape Respirator

CET-APRS-STP-CBRN0414 Fogging

Draft test procedure for fogging is 

in place, but final STP has not been 

published. Contact NIOSH for 

further information.

TEB-APR-STP-0417-

CBRN

Determination of 

Flammability and Heat 

Resistance, CBRN AirPurifying Escape Respirators

CET-APRS-STP-CBRN0450

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sarin 

Vapor of Chemical, Biological, 

Radiological, and Nuclear AirPurifying Escape Respirator

GB (SMARTMAN) Qualifier 

LAT(QLAT) Only 1 +

CET-APRS-STP-CBRN0450

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sarin 

Vapor of Chemical, Biological, 

Radiological, and Nuclear AirPurifying Escape Respirator

GB (SMARTMAN) Remainder 

LAT (RLAT) 2 trials +

CET-APRS-STP-CBRN0451

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sulfur 

Mustard Liquid And Vapor of 

the Chemical, Biological, 

Radiological, and Nuclear AirPurifying Escape Respirator

HD (SMARTMAN) QLAT Only 1 

+

CET-APRS-STP-CBRN0451

Determination of Chemical 

Agent Permeation and 

Penetration Resistance 

Performance Against Sulfur 

Mustard Liquid And Vapor of 

the Chemical, Biological, 

Radiological, And Nuclear AirPurifying Escape Respirator

HD (SMARTMAN) RLAT 2 trials 

+
8/4/2022 SCBA and CBRN SCBA

58

TEB-CBRN-APR-STP0452

Determination of Laboratory 

Respirator Protection Level 

Values for CBRN Air-Purifying 

Escape Respirator 

CET-APRS-STP-CBRN0455Human Subject Breathing Gas 

Test

Draft test procedure for human 

subject breathing gas test is in 

place, but final STP has not been 

published. Contact NIOSH for 

further information.

+Tests performed at RDECOM.

* Actual tests selected may vary depending on design 

and intended use.

All of the NIOSH Standard Test Procedures are located at: 

https://www.cdc.gov/niosh/npptl/stps/respirator_testing.html.
8/4/2022 SCBA and CBRN SCBA

59

Section 6 Checklists for Self-Contained Breathing Apparatus 

 or CBRN Self-Contained Breathing Apparatus 

The following checklists will be used by NIOSH to review submitted documents for compliance to this 

procedure and 42 CFR Part 84. It is recommended that applicants review their documents using these 

checklists prior to submitting them to NIOSH. These checklists may not be all-inclusive. 

6.1 NIOSH Respirator Application Checklist

1. _____ The AAR# is unique to the application.

2. _____ All the applicable sections of the SAF are complete.

3. _____ The “Reason for Application” accurately reflects why the application is being submitted

(e.g. New Approval, Extension of Approval, Quality Assurance Approval, Correlation 

Testing Only, Resubmission of New Approval, Resubmission of Extension of Approval, 

or Amended Application). 

4. _____ The NIOSH TN under which this (these) respirator(s) were last tested has been

identified.

5. _____ All the files included with the application are listed in the SAF.

6. _____ All the files supplied are in the acceptable file formats.

7. _____ All the files are properly identified/listed in the SAF.

If Test Samples (Hardware) 

8. _____ Shipped under a separate cover.

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

part numbers as listed on the assembly matrix. 

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

matrix. 

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

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

quantity(ies) shipped.

Fees

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

included. 

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

15. _____ The check is payable to NIOSH.

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

17. _____ The check includes the AAR#.

Assembly Matrix

18. _____ The assembly matrix matches what is listed in the “Reason for Application” section of

the SAF. All applications, except QA Applications, require an assembly matrix.

19. _____ The assembly matrix and SAF represent the actual configuration of the new or modified

approval.

20. _____ The “Reason for Application” accurately reflects what is being requested (e.g. New

Approvals, Extension of Approval, Quality Assurance Approval, Correlation Testing Only, 
8/4/2022 SCBA and CBRN SCBA

60

Resubmission of New Approval, Resubmission of Extension of Approval, or Amended 

Application). 

21. _____ R’s are placed in the boxes that are associated with any change to the referenced

components, including drawings, PQP’s, inspection procedures, or any other 

documents.

Drawings

22. _____ The necessary new or revised drawings are included in the application documents.

23. _____ The revision levels on all drawings match those listed on the assembly matrix.

24. _____ Item numbers on the exploded-view drawing match the item numbers on the assembly

matrix.

25. _____ All required information is present on the Self-Contained Breathing Apparatus

drawings, as indicated on the appropriate checklists. 

Labels

26. _____ All applicable draft approval labels are included with the application (respirator, along

with other labels as required).

27. _____ The assemblies identified on the label match those identified on the matrix (or matrices)

with the possible exception of accessories and User Instructions. 

28. _____ The harness labels, primary company, and private label company, if applicable, are

listed and shown on page two of the applicable drawings.

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

assembly matrix.

Cautions and Limitations

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

approvals.

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

label(s).

User Instructions

32. _____ The User Instructions include all the required information e.g. OSHA 1910.134

statement on fit testing, donning instructions, assembly instructions, additional 

warnings and cautions, private label statement (as required), name and contact 

information of the appropriate company. 

Final Review of Application Documents

33. _____ All documents have been verified for the correct revision numbers and the revision

levels match what is listed in the SAF.

34. _____ Pre-submission testing indicating that all performance requirements specified in 42 CFR

Part 84 is provided in the application and is complete. 
8/4/2022 SCBA and CBRN SCBA

61

6.2 Exploded-View Drawing Checklist for a Self-Contained Breathing 

Apparatus or CBRN Self-Contained Breathing Apparatus 

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

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

2. _____ Parts that are obsolete from the matrix should not appear on the exploded-view drawing.

3. _____ The reference numbering on the exploded-view drawing matches the reference

numbering on the assembly matrix. All matrix assemblies are represented on the 

exploded-view drawing and there are no extra assemblies on the exploded-view drawing. 

For every reference number on the drawing there is a corresponding number on the 

matrix, and vice versa.

4. _____ The drawing is properly titled, signed/initialed, numbered, dated, and contains a

revision level.

5. _____ There are no reference dimensions on the drawing.
8/4/2022 SCBA and CBRN SCBA

62

6.3 Major Subassemblies Checklist for a Self-Contained Breathing 

Apparatus or a CBRN Self-Contained Breathing Apparatus 

1. _____ Numbered, titled, signed/initialed by an authorized representative, with an effective

date and revision level.

2. _____ Dimensions: length, width, or diameter, as applicable are referenced.

3. _____ Material specifications or vendor part number is listed.

4. _____ Part number location is listed.

5. _____ Serial number location, if applicable, is listed.

6. _____ Critical and major characteristics must be identified on the drawing or on a separate

document.

7. _____ Inspection procedures or classification of defects are identified on the drawing or in

additional documentation provided with the drawing.

8. _____ Expiration date is indicated, if applicable.
8/4/2022 SCBA and CBRN SCBA

63

6.4 Self-Contained Breathing Apparatus or CBRN Self-Contained 

Breathing Apparatus 

1. _____ Confirm that any materials used in the construction of the respirator which may be

exposed to oxygen pressures above atmospheric pressure are safe and compatible for 

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

Cylinder and Valve

1. _____ Burst disc pressure is given on the drawing, or there is a note that states that it meets

CGA S-1.1 6.3. The requirement is 90-100% of 5/3 service pressure. 

• Cylinder fill pressure x 5 ÷ 3 = upper limit.

• Highest pressure x .90 = lower limit.

2. _____ Torque requirement for connection of cylinder valve to cylinder is listed.

3. _____ Cylinder construction (material(s) of construction, fiber reinforced, type of fiber) is

listed. 

4. _____ Full cylinder volume at operating pressure: Compressed Air Volume is listed.

5. _____ Markings on cylinder: compressed breathing air, compressed breathing oxygen, liquefied

breathing air, or liquefied breathing oxygen, adhere to DOT marking requirements.

6. _____ Pressure gauge range has a scale reliable to within + or - 5% of full scale (minimum of

five graduations empty, 1/4, 1/2, 3/4, full).

7. _____ Where pressurized oxygen is used, the gauge must have the words “oxygen” and

“use no oil.” Also, if it is a closed-circuit unit with oxygen, all materials must be 

compatible for use with oxygen.

8. _____ Procedure to assure proper gas mixture for refill purposes (percent oxygen) is included.

Applies to specialty gases only; does not apply to grade D air.

9. _____ Specification and dimensions of outlet threads are listed.

Respiratory Inlet Covering (Facepiece or Hood)

1. _____ If a pressure-demand valve is present, shows it is spring loaded.

2. _____ Lens meets impact resistance GGG-M-125d Oct. 11, 1965 (amended July 30, 1969).

3. _____ Lens has statement if antifog is needed or not.

4. _____ Statement to indicate if and when nosecup assembly is needed.

Backpack Harness Assembly

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

the buckles is included. 

2. _____ Location of NIOSH harness label is indicated.

Pneumatic Assembly

1. _____ For all compressed gas SCBA, a statement that it has an inline filter downstream of the

air source that will effectively remove particles from the gas stream (42 CFR Section 

84.87). 

2. _____ Type of connections on SAR hose (for an SCBA/SAR combination) is listed.
8/4/2022 SCBA and CBRN SCBA

64

3. _____ Pressure gauge range has a scale reliable to within + or - 5% of full scale (minimum

of five graduations: empty, 1/4, 1/2, 3/4, full).

4. ______ When pressurized oxygen is used, gauge has the words “oxygen” and “use no oil.”

5. _____ Statement showing all SCBA components critical to the performance of the

respirator will function at the minimum temperature, including seals and O-rings (42 

CFR Section 84.98).

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

listed. 

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

First Stage Regulator

1. _____ Intermediate Pressure Range is listed.

2. _____ Regulator is designed to fail in the open position.

Second Stage Regulator Assembly

1. _____ Parts list showing all parts and materials of the regulator is included.

2. _____ If a belt mounted regulator assembly, a pressure relief valve is required along with a

statement of diaphragm over-pressurization requirement.
8/4/2022 SCBA and CBRN SCBA

65

6.5 Supplied-Air Respirator

Respiratory Inlet Covering (Facepiece/Hood/Helmet)

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

30, 1969). Does not apply to types A, AE, B, and BE. 

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

1. _____ Parts list required showing all parts that make up the air supply valve/orifice/regulator.

Hose/Couplings

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

manufacturer name (example: Foster-Schrader which we would interpret to be a 

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

number must be identified; it cannot be listed as “or equivalent.” 

2. _____ Maximum pressure rating of hose.

Breathing Tube

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

clamps on the breathing tube.
8/4/2022 SCBA and CBRN SCBA

66

6.6 Private Label Checklist for a Self-Contained Breathing Apparatus

or a CBRN Self-Contained Breathing Apparatus 

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

included. 

2. _____ If private label SCBA is a different model/part number than primary approval holder’s

number, part number and description are in a new separate column on the matrix. 

3. _____ If the private label is the same model/part number as the primary approval holder’s

model/part number, the approval holder name and private label company name are in 

the description column of the primary Self-Contained Breathing Apparatus model/part 

number.

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

5. _____ The harness label is included on page two of the drawing.

A. _____ Abbreviated/Harness label must include the following items:

a. Private label company name.

b. NIOSH is printed in block letters.

c. Appropriate approval (TC) number(s).

d. Model or part number.

e. Cautions and limitations.

B. _____ A draft of the full private label approval label is included and includes

cautions and limitations special “S.”

C. _____ Private label User Instructions are included.

D. _____ “S” Special User Instructions section is required with the statement:

Model nnnn Self-Contained Breathing Apparatus has been 

manufactured by approval holder xxx for private label company yyyy 

under TC-13F-nnnn or TC-13F-CBRN-nnnn. 

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

application or on a separate sheet. 
8/4/2022 SCBA and CBRN SCBA

67

6.7 Assembly Matrix Checklist for a Self-Contained Breathing Apparatus

 or a CBRN Self-Contained Breathing Apparatus 

This checklist corresponds to the Example Assembly Matrix in Section 7.2

1. _____ The title of the document is indicated on the top of the page.

2. _____ The assembly matrix has the following information in the top right corner of the page:

a. Title.

b. Applicant’s name and address.

3. _____ The following is indicated below the key box:

a. Date.

b. Revision level, if applicable.

4. _____ New drawings submitted with the application or the drawing revision level reflects the

current revision level on file at NIOSH. If the drawing has changed from what is currently 

on file at NIOSH, the altered drawing needs submitted with the appropriate revision 

level noted. If the drawing is within another application at NIOSH, this information must 

be identified in the “Reason for Application” section. 

5. _____ The numbering system used for assemblies shown on the matrix and exploded-view

drawing match. 

6. _____ The part number marked on the component must appear in the part number row

(model numbers optional).

7. _____ Features that describe the respirator are not listed as a separate column on the matrix.

 Features associated with specific model numbers may be coupled together in the 

description (e.g., Model 1201 with Quick Attachment cylinder). 

8. _____ Top row (A) must be a general category, i.e., facepiece, etc. Accessories must be

included. “Alternate” will be in the column heading if there are more than one of the 

same assemblies.

9. _____ The NIOSH TN (B) where the component was last tested is listed in the bottom row. If

new, indicate N. 

10. _____ The AAR# (C) appears in the first column from the left.

11. _____ The TC number (D) appears in the second column from left.

a. A new TC number is listed in the proper format: schedule# and AAR# followed

by an alpha character.

b. List “TC-” only in the category heading.

12. _____ The list of protections (E) appears in the third column from left.

a. Verify the list matches the protections listed in the SAF. See the complete list of

protections and cautions and limitations.

13. _____ The key box (F) must use only the characters X, N, P, R, -, or A.

14. _____ TN/AAR# of the previously approved/pending matrix (G) is noted above the right-hand

side of the table.

15. _____ Current exploded-view drawing number (H) and revision is located directly below the

TN/AAR# of the previously approved/pending matrix.

16. _____ A column for the part number/revision level of the User Instructions must be used.
8/4/2022 SCBA and CBRN SCBA

68

Section 7 - Document Examples for a Self-Contained Breathing 

 Apparatus or a CBRN Self-Contained Breathing 

 Apparatus 

7.1 Example of a Product Quality Plan for Self-Contained Breathing 

Apparatus or CBRN Self-Contained Breathing Apparatus 
8/4/2022 SCBA and CBRN SCBA

69

Double Wing Manufacturing

123 Manufacture Lane

Pittsburgh, PA USA

Phone: 412-555-1212

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

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

Exploded-view drawing number: DWM005

(G)

(H)

(F)

7.2 Example of an Assembly Matrix for a Self-Contained Breathing 

Apparatus 

Key: 

X=Currently Approved in this Configuration

N=New Component or Configuration

"-"=Obsolete

R=Redesign/Revision

P=Pending

A=Accessory

Date: August 15, 2015

Revision: 0

Item 4 6 2 3 8 9

Revision 0 1 2 2 1 2 2 0

Drawing 

Number

PRI PG001 SS01 H01 CM002 LN001 CS01 N/A

Descript

ion

First 

Stage 

Regulator

Remote 

Guage 

and 

PASS 

Unit

Mask 

Mount 

Regulator

Interior 

Hose

Control 

Module

Lens Case Instruct

ions

Ca

(D)

Protection 

(E) 

Part 

Number 100 200 300 H95 H99 FR333 PG004 C01 C02 C03 C04 R333 IH333 CM001

LENS

10

CASE

20

Instruct

ions

13FAARa

30 min/ 

2216 psi/ 

SC/PD

FF 100 

SCBA

N N N N N N N N N N N N N

13FAARb

30 min/ 

4500 psi/ 

SC/PD

FF 100 

SCBA

N N N N N N N N N N N N N

13FAARc

45 Min/ 

4500 psi/ 

SC/PD

FF 100 

SCBA

N N N N N N N N N N N N N

13FAARd

30 Min/ 

4500 psi/ 

SC/PD

FF 100 

SCBA

N N N N N N N N N N N N N

N N N N N N N N N N N N N N N N N

(B) NIOSH Task Number

Where the Component was 

Last Tested (If New, 

Indicate as "N")

Pass/

Gauge 

Unit

Second 

Stage 

Regulator

Control 

Module

2

CLDR001

Full 

Facepiece

Backframe 

and 

Harness

Compressed Air 

Cylinders

Alternate Cylinder Hose Accessories

Instruct

ions

2

FP100

0

HR200

Alternate 

Harness

Pressure 

Reducer

1 7 5 10

(A)

Alternate 

Facepiece
8/4/2022 SCBA and CBRN SCBA

70

Double Wing Manufacturing

123 Manufacture Lane

Pittsburgh, PA USA

Phone: 412-555-1212

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

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

Exploded-view drawing number: DWM005

(G)

(H)

(F)

7.3 Example of an Assembly Matrix for a CBRN Self-Contained Breathing 

Apparatus

Key:

X=Currently Approved in this Configuration

N=New Component or Configuration

"-"=Obsolete

R=Redesign/Revision

P=Pending

A=Accessory

Date: August 15, 2015

Revision: 0

Item 4 6 2 3 8 9

Revision 0 1 2 2 1 2 2 0

Drawing 

Number

PRI PG001 SS01 H01 CM002 LN001 CS01 N/A

Descript

ion

First 

Stage 

Regulator

Remote 

Guage 

and 

PASS 

Unit

Mask 

Mount 

Regulator

Interior 

Hose

Control 

Module

Lens Case Instruct

ions

Ca

(D)

Protection 

(E) 

Part 

Number 100 200 300 H95 H99 FR333 PG004 C01 C02 C03 C04 R333 IH333 CM001

LENS

10

CASE

20

Instruct

ions

13FAARaCBRN

30 min/ 

2216 psi/ 

SC/PD/EO 

STI 33

FF 100 

SCBA N N N N N N N N N N N N N

13FAARbCBRN

30 min/ 

4500 psi/ 

SC/PD/EO 

STI 33

FF 100 

SCBA N N N N N N N N N N N N N

13FAARcCBRN

45 Min/ 

4500 psi/ 

SC/PD/EO 

STI 33

FF 100 

SCBA N N N N N N N N N N N N N N

13FAARdCBRN

30 Min/ 

4500 psi/ 

SC/PD/EO 

STI 33

FF 100 

SCBA N N N N N N N N N N N N N

N N N N N N N N N N N N N N N N N

(B) NIOSH Task Number

Where the Component was 

Last Tested (If New, 

Indicate as "N")

Pass/

Gauge 

Unit

Second 

Stage 

Regulator

Control 

Module

2

CLDR001

Full 

Facepiece

Backframe 

and 

Harness

Compressed Air 

Cylinders

Alternate Cylinder

EBSS 

Hose Accessories

Instruct

ions

2

FP100

0

HR200

Alternate 

Harness

Pressure 

Reducer

1 7 5 10

(A)

Alternate 

Facepiece
8/4/2022 SCBA and CBRN SCBA

71

7.4 Example of an Exploded-View Drawing for a Self-Contained Breathing 

Apparatus or a CBRN Self-Contained Breathing Apparatus

Item Part Number Description

1 X000 Facepiece

2 R333 Second Stage Regulator

3 IH333 Intermediate Hose

4 FR333 First Stage Regulator

5 C004 Cylinder

6 PG00X Pass/Gauge Unit

7 HXX Harness

8 CM001 Control Module

10 ACS01 Accessory

Approved Double Wing Manufacturing, Pittsburgh, PA

Drawing: DWW 8/25/2015 Part Number: Model 

FF100

Title: SCBA FF100 

Release: DDW 8/26/2015 Scale: NTS Revision: 

0 

Drawing Number DWM005

1 2

3

4

5

6

7

8

10

DWM
8/4/2022 SCBA and CBRN SCBA

72

7.5 Example of an Approval Label for a Self-Contained Breathing Apparatus

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

1900 Series SCBA

Open-Circuit, Pressure-Demand, Entry, Self-Contained Breathing Apparatus

These Respirators are approved only in the following configurations:

1. PROTECTION

PD - Pressure-Demand

SC - Self-Contained

2. CAUTIONS AND LIMITATIONS

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres. 

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, 

OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as 

specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of 

these respirators.

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

before donning. 

[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions. 

This includes cold temperature limitations, air quality requirements, etc. that were listed on old Part 11 

label.]

TC- Protection1

Cautions

and 

Limitations2

1000 2000 3000 4000 H95 H96 H97 H98 H99 C001 C002 C003 C004 R111 R222 R333 LENS

10

ALARM

50

CASE

20

13FAARa

30 min/ 

2216 psi/ 

SC/PD

X X X X X X X X X X X IJMNOS

13FAARb

30 min/ 

4500 

psi/SC/PD

X X X X X X X X X X X X IJMNOS

13FAARc

45 min/ 

4500 

psi/SC/PD

X X X X X X X X X X IMNOS

13FAARd

60 min/ 

4500 

psi/SC/PD

X X X X X X X X X IJMNOS

RESPIRATOR COMPONENTS

Alternate Facepiece Alternate Harness Alternate Cylinder Alternate 

Regulator

Accessories
8/4/2022 SCBA and CBRN SCBA

73

7.6 Example of an Approval Label for a CBRN Self-Contained Breathing Apparatus

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

1900 Series CBRN SCBA

Open-Circuit, Pressure-Demand, Entry and Escape CBRN Self-Contained Breathing Apparatus

These respirators are approved only in the following configurations: 

Respirator Components

TC- Protection1 Alternate Facepiece Alternate Harness Alternate Cylinder

Alternate 

Regulator Accessories

Cautions 

and 

Limitions2/3

10

00

20

00

30

00

40

00 H95 H96 H97 H98 H99

C0

01

C0

02

C0

03

C0

04

R1

11

R2

22

R3

33

Lens

10

Alarm

50

Case

20

13FAARa

-CBRN

30 min/ 

2216 psi/ 

SC/PD/ 

EOSTI 33 X X X X X X X X X X X

IJMNOS,

ORTUEBSS

13FAARb

-CBRN

30 min/ 

4500 psi/ 

SC/PD/ 

EOSTI 33 X X X X X X X X X X X X

IJMNOS,

ORTUEBSS

13FAARc

-CBRN

45 min/ 

2216 psi/ 

SC/PD/ 

EOSTI 33 X X X X X X X X X X

IJMNOS,

ORTUEBSS

13FAARd

-CBRN

60 min/ 

2216 psi/ 

SC/PD/ 

EOSTI 33 X X X X X X X X X

IJMNOS,

ORTUEBSS

1. PROTECTION

PD - Pressure-Demand EOSTI - End-of-Service-Time Indicator

SC - Self-Contained CBRN - Chemical, Biological, Radiological, and Nuclear

2. CAUTIONS AND LIMITATIONS

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres. 

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, 

OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as 

specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of 

these respirators.

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

before donning. 

3. CAUTIONS AND LIMITATIONS OF USE FOR CBRN SCBA

Q Use in conjunction with personal protective ensembles that provide appropriate levels of protection 

against dermal hazards.

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

impairment, illness, or death.
8/4/2022 SCBA and CBRN SCBA

74

T Direct contact with CBRN agents requires proper handling of the SCBA after each use and between 

multiple entries during the same use. Decontamination and disposal procedures must be followed. If 

contaminated with liquid chemical warfare agents, dispose of the SCBA after decontamination.

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

agents to avoid possibility of agent permeation. 

EBSS EBSS Activation or engagement of EBSS in either the donor or receiver mode changes the SCBA use to 

Escape-Only, approved service time for either the donor, or the receiver. 
8/4/2022 SCBA and CBRN SCBA

75

7.7 Example of an Approval Label for a Self-Contained Breathing Apparatus and 

a Combination SCBA/SAR

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

1955 Series SCBA

Open-Circuit, Pressure-Demand, Entry and Escape, Self-Contained Breathing Apparatus

and

Open-Circuit, Pressure-Demand, Entry and Escape, Combination Self-Contained Breathing Apparatus and 

Type C Supplied-Air Respirator

These respirators are approved only in the following configurations:

Respirator Components

TC- Protection1 Alternate 

Facepiece Alternate Harness Alternate Cylinder

Alternate 

Hoses

Alternate 

Regulator Accessories Cautions and Limitations2

1

0 

0 

0 

2 

0 

0 

0 

3 

0 

0 

0 

4 

0 

0 

0 

H 

9 

5 

H 

9 

6 

H 

9 

7 

H 

9 

8 

H 

9

9 

C 

0 

0 

1 

C 

0 

0 

2 

C 

0 

0 

3 

C 

0 

0 

4 

2 

5 

5 

0 

1 

0 

0 

R 

1 

1 

1 

R 

2

2 

2 

R 

3 

3 

3 

L 

E 

N 

S 

1 

0 

A

L 

A 

R 

M 

5 

0

C 

A 

S 

E 

2 

0 

13F-AARa 30 min. 2216 

psi SC/PD X X X X X X X X X X X IJMNOS

13F0-AARb 30 min. 4500 

psi SC/PD X X X X X X X X X X X X IJMNOS

13F0-AARc 45 min. 4500 

psi SC/PD X X X X X X X X X X IJMNOS

13F-AARd 60 min. 4500 

psi SC/PD X X X X X X X X X IJMNOS

13F-AARc 30 min. 2216 

psi SC/SA/PD X X X X X X X X X X X X X X DEIJMNOS

1. PROTECTION

PD - Pressure-Demand SC - Self-Contained SA - Supplied-Air

2. CAUTIONS and LIMITATIONS

D Air-line respirators can be used only when the respirators are supplied with respirable air meeting the 

requirements of CGA G-7.1, Grade D or higher quality.

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

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres. 

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, 

OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as 

specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of 

these respirators.
8/4/2022 SCBA and CBRN SCBA

76

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

before donning.

 [Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions. 

This includes cold temperature limitations, air quality requirements, etc. that were listed on old Part 11 label.]
8/4/2022 SCBA and CBRN SCBA

77

7.8 Example of an Approval Label for a Self-Contained Breathing Apparatus

Harness

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

Easy-Carry SCBA

Open-Circuit, Pressure-Demand, Entry and Escape Self-Contained Breathing Apparatus

TC-13F-XXX 30 MINUTE 2216 PSIG

TC-13F-YYY 30 MINUTE 4500 PSIG

TC-13F-ZZZ 45 MINUTE 4500 PSIG

TC-13F-AAA 60 MINUTE 4500 PSIG

 (Refer to the Approved User Instructions for the Complete List 

of Components that Make Up the Approved Assembly) 

 Cautions and Limitations 

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres. 

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with 

MSHA, OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the 

configuration as specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and 

maintenance of these respirators.

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

Instructions before donning.

[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions. 

This includes cold temperature limitations, air quality requirements, special use instructions, etc. that were 

listed on old Part 11 label.]
8/4/2022 SCBA and CBRN SCBA

78

7.9 Example of an Approval Label for a CBRN Self-Contained Breathing 

 Apparatus Harness

Double Wing Manufacturing Company

Almost Heaven, West Virginia, USA

1-800-123-4567

Model FFCBRN SCBA

Open-Circuit, Pressure-Demand, Entry and Escape Self-Contained Breathing Apparatus

TC-13F-XXXCBRN 30 MINUTE 2216 PSIG

TC-13F-YYYCBRN 30 MINUTE 4500 PSIG

TC-13F-ZZZCBRN 45 MINUTE 4500 PSIG

TC-13F-AAACBRN 60 MINUTE 4500 PSIG

 Refer to the Approved User Instructions for the Complete List 

of Components that Make Up the Approved Assembly.

 Cautions and Limitations 

I Contains electrical parts that may cause an ignition in flammable or explosive atmospheres. 

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

M All approved respirators shall be selected, fitted, used, and maintained in accordance with 

MSHA, OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the 

configuration as specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and 

maintenance of these respirators.

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

Instructions before donning.

Q Use in conjunction with personal protective ensembles that provide appropriate levels of 

protection against dermal hazard.

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

impairment, illness, or death.

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

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

be followed. If contaminated with liquid chemical warfare agents, dispose of the respirator after 

decontamination.

U The respirator should not be used beyond 6 hours after initial exposure to chemical warfare 

agents to avoid possibility of agent permeation.

[Note: All appropriate cautions and limitations must be listed in a separate section of the User Instructions. 

This includes cold temperature limitations, air quality requirements, special use instructions, etc. that were 

listed on old Part 11 label.]
8/4/2022 SCBA and CBRN SCBA

79

Section 8 - Label Format Guidance • Labels for Self-Contained Breathing Apparatus and CBRN Self-Contained Breathing Apparatus must be

completed in the assembly matrix format shown in the preceding examples.

• The TC number is listed in the far left column. For initial submittals the TC number is the schedule and

AAR# followed by an alpha character, exactly as in the assembly matrix. This links the approval label to

the application and assembly matrix. Upon approval, NIOSH will insert the TC number. “TC-” can only

appear in the column heading, not in the row.

• Protections are the second column from the left.

• Cautions and limitations are the far right column.

• The component columns must list all of the major assemblies and accessories and can be in any order

that the applicant chooses.

• Anytime more than one of the same assemblies for a respirator configuration are listed on the

approval label, they must be identified as alternate components by adding “Alternate” to the column

heading. X is the only character that may be used in the body of the approval label to designate an

approved component.

• If a component is offered as an accessory, the category must be labeled as “accessory” (e.g.,

“Accessory Cover").

• Empty rows are not permitted. Approval labels must not be color coded.

• Wording of the standard protections and cautions and limitations must be identical to the NIOSH

samples. Only appropriate cautions and limitations may be listed. For example, if only cautions and

limitations A, C, and G apply, then only A, C, and G can be footnoted at the bottom of the label.

• The SCBA harness label must clearly indicate the approval holder’s name, address, and phone number,

model/trade name, type of protection, TC number, duration-cylinder pressure-type data, appropriate

cautions and limitations, reference to the User Instructions for major subassembly and component

information, and HHS and NIOSH logos.

• The entire SCBA or SAR label must appear in the User Instructions.

• Protections on SCBA approval labels, User Instructions and assembly matrices must list the cylinder

operating pressure, rated service time, and self-contained code e.g., 2216 psig 30 min SC. Protections

are to include the End-of-Service-Time Indicator version (EOSTI-25 or EOSTI-33).

• If all respirators on the label are of the same series or family, text may be added to identify the

respirator series or family, e.g., continuous flow, pressure-demand, positive pressure, Type C or Type

CE, open-circuit, closed-circuit, etc. This heading is optional on all approval labels.

• Non-NIOSH approval identifiers cannot be represented on any NIOSH labels. Applicants may use

additional areas on the component to identify any other applicable approvals such as the European CE

approval. However, this information must be separated from the NIOSH approval label.

• If the label will not fit on the container, it must be included inside the container. If the label is inserted,

the container must say “NIOSH-Approved - see insert.” The insert may consist of the approval label or

the User Instructions containing the approval label.

• If the respirator is for escape-only, the applicant must use the word escape on full approval labels. For

example, “These escape-only respirators are approved only in the following configurations.” ‘Escape’

may be abbreviated in the protection column but must be spelled out in the legend. “Esc” is the only

acceptable abbreviation for escape.
8/4/2022 SCBA and CBRN SCBA

80

APPENDIX
8/4/2022 SCBA and CBRN SCBA

81

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control

and Prevention (CDC)

National Institute for Occupational

Safety and Health (NIOSH)

National Personal Protective 

Technology Laboratory (NPPTL)

P.O. Box 18070 

Pittsburgh, PA 15236

Phone: 412-386-4000

Fax: 412-386-4051

September 24, 2012 

LETTER TO ALL RESPIRATOR MANUFACTURERS 

Subject: Sampling Procedures 

The National Institute for Occupational Safety and Health (NIOSH) requires that respirator approval 

holders inspect and/or test samples of respirators and components as part of their quality control 

plans. This requirement is stated in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84), 

specifically in §§ 84.41(b) through 84.41(i). Some applicants or approval holders have had difficulty 

understanding how to select and use a sampling procedure which meets the requirements. This 

letter is intended to explain the practical use of common standard procedures acceptable to NIOSH. 

This letter will not discuss statistical theory underlying acceptance sampling. If applicants or 

approval holders intend to use alternatives to the procedures described here, they must understand 

the concepts of acceptance sampling and process control. The use of more modern methods such as 

calculating process capability values (Cpk) or employing statistical process control (SPC) is 

encouraged where this is compatible with the approval holder’s operations and provides equivalent 

assurance of respirator performance. Justification to demonstrate the equivalence of these 

procedures must be provided in the application seeking approval. 

1. Selection of Sampling Procedures

1.1 Sampling by Variables. The standard sampling procedure specified in 42 CFR Part 84 is MIL-STD414 [U.S. Department of Defense 1957]. This is a variable sampling plan, which means that the

characteristic must be something that can be measured numerically on a continuous scale.

Examples include the diameter of a hole in inches, the mass of a cartridge in grams, or the leakage

of an exhalation valve in milliliters per minute. This procedure is only valid when the characteristic

being measured has a statistically normal distribution over the population being sampled. The

ANSI/ASQ Z1.9 standard [American National Standards Institute 2003b] is derived from MIL-STD414, and NIOSH considers it to be equivalent.

1.2 Sampling by Attributes. The MIL-STD-105D sampling procedure [U.S. Department of Defense 

1963] is explicitly accepted as an equivalent procedure in 42 CFR Part 84. This is an attribute sampling 

plan, which means that each characteristic is simply checked to see whether it is acceptable. Due to 

its simplicity, this standard and its derivatives are by far the most common in use. It has the 
8/4/2022 SCBA and CBRN SCBA

82

advantage that it can be applied to characteristics which do not involve a numerical measurement 

(such as visual checks) as well as to those that are measurable. No calculations are needed to 

determine acceptance, and the procedure is valid whether the Page 2 – Letter to All Respirator 

Manufacturers 9-2012 characteristic has a normal distribution or not. Typically the sample sizes will 

be larger than the corresponding variable sampling plan. Procedures derived from this standard, and 

which NIOSH considers to be equivalent, include MIL-STD-105E [U.S. Department of Defense 1989] 

and ANSI/ASQ Z1.4 [American National Standards Institute 2003a]. 

1.3 Zero-Defect Sampling by Attributes. Another attribute sampling plan which NIOSH accepts as equivalent 

is the Squeglia C=0 procedure [Squeglia 2008]. While not directly derived from MIL-STD-105E, its plans are 

matched to that procedure and provide an acceptable statistical assurance of lot quality. The chief difference 

is that in all cases, the lot is only accepted if there are zero defects found in the sample (C=0). This procedure 

usually requires fewer samples than MIL-STD-105D and related standards, and is the simplest to use of those 

listed in this letter. However, it is generally only suitable when defects in production are extremely rare. 

1.4 Equivalent Standards. The ANSI/ASQ standards mentioned above are revised periodically. In general, 

NIOSH will consider later editions of a given procedure to be equivalent. There may also be other national or 

international standards based on MIL-STD-414 or MIL-STD-105D that can be considered equivalent. If such a 

standard is used, NIOSH may request a copy from the applicant to verify its equivalence. 

1.5 Obtaining Sampling Procedure Documents. One feature of MIL-STD plans is that as works of the United 

States Government, they may be copied free of charge. Those mentioned can be downloaded from the 

Internet Archive at http://www.archive.org/ and may be available elsewhere. However, all MIL-STD 

documents in this letter have been cancelled by the Department of Defense and are no longer maintained or 

revised. The corresponding ANSI/ASQ standards are successors to the MIL-STD documents and have various 

minor improvements and clarifications added. Copies of these standards may be purchased from the 

American Society for Quality, the American National Standards Institute, or others who deal in national 

standards. 

2. Acceptable Quality Level (AQL)

• Meaning of AQL. The acceptable quality level is an indicator of the percent defective that can be

considered satisfactory for a particular characteristic. Smaller AQL values mean that fewer defectives

will be tolerated in an acceptable lot.

• Selection of AQL. The classification of defects document submitted with each application as required

by 42 CFR Section 84.41(c) through 84.41(e) must identify the severity level of each characteristic. The

AQL to be used for sampling is shown in the table below and is defined in 42 CFR Section 84.41(g). The

AQL value does not depend on lot size or any other factor, and it is generally improper to modify the

AQL for any reason other than the defect classification.

1 These are called “index values” in the Squeglia C=0 procedure.

Defect Classification AQL1,2

Major A 1.0

Major B 2.5

Minor 4.0
8/4/2022 SCBA and CBRN SCBA

83

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 lot size and determinesthe sampling plan’s ability to discriminate between conforming and

nonconforming lots. Lower inspection levels increase the risk that a nonconforming lot will be accepted.

3.2 Selection of Inspection Level. The inspection level to be used is shown in the “normal” column of the

table below and is defined in 42 CFR Section 84.41(h). As a special exception, NIOSH is permitted under 42

CFR Section 84.41(i) to allow a lower inspection level for destructive testing only. The minimum level NIOSH

will accept under this exception isin the “destructive” column. Approval of a level lower than the “normal”

level is entirely at NIOSH’s option and will only be granted if the rest of the inspection plan ensures

adequate control over product quality.

1 Only permitted with specific prior approval from NIOSH.

The Squeglia C=0 procedure does not use the concept of inspection levels and NIOSH treats it as equivalent

to inspection level II of MIL-STD-105D.

3.3 Cross-References. See MIL-STD-414 section A7.1; ANSI/ASQ Z1.9-2003 section A7.1; MIL-STD-105D

sections 9.2, 9.3; MIL-STD-105E sections 4.9.1, 4.9.2; ANSI/ASQ Z1.4-2003 sections 9.2, 9.3.

4. Normal, Reduced, and Tightened Inspection

4.1 Use of Switching Rules. Most sampling procedures referenced in this letter contain rules allowing

reduced inspection under certain conditions. Reduced inspection may be used only when all conditions

listed in the switching rules are met. This includes the requirement that production is not irregular or

delayed. A history of lot acceptance at one manufacturing site cannot be used to move to reduced sampling

at another site. Approval holders may choose to stay at normal inspection even when conditions for

reduced inspection are met. However, tightened inspection is not optional and must be used where

specified by the rules. The Squeglia C=0 procedure does not recommend switching rules, and reduced

Procedure Minimum Inspection Level

Normal Destructive1

MIL-STD-414 IV I

ANSI/ASQ Z1.9-2003 II S-3

MIL-STD-105D II S-2

MIL-STD-105E II S-2

ANSI/ASQ Z1.4-2003 II S-2
8/4/2022 SCBA and CBRN SCBA

84

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 records showing that the conditions in the applicable procedure are met. Such

records must be available for review during NIOSH on-site audits.

4.3 Cross-References. See MIL-STD-414 sections A8, B14, C14, D14; ANSI/ASQ Z1.9-2003 section A10; MILSTD-105D section 8; MIL-STD-105E sections 4.6, 4.7, 4.8; ANSI/ASQ Z1.4-2003 section 8; Squeglia C=0

pages 14, 16.

5. Lots or Batches

5.1 Definition of Lot. Each procedure listed in this letter requires that product be grouped into inspection

lots (the term “batch” means the same as “lot”). Each lot consists of product which has been manufactured

under essentially the same conditions in the same production facility and at essentially the same time. For

example, if a production line is shut down for a week for maintenance, it is wrong to consider product made

before and after the shutdown as part of the same lot.

5.2 Selection of Samples from Lot. Each sample drawn from a lot must be representative of the lot. For

example, when drawing a sample of 200 pieces from a lot of 10,000 it would be improper to select the first

200 respirators produced to use as the sample. As another example, if respirators being produced on five

machines are being combined into an inspection lot, then one- fifth of the sample drawn must come from

each machine. As noted in section 6.2 of this letter, each sample taken for double or multiple sampling must

be representative of the whole lot.

5.3 Inspection Lot vs. Other Lot Designations. The grouping of finished respirators into lots for shipment or

other purposes may differ from the grouping used for inspection. The lot number marked on the respirator

or its container, as required by 42 CFR Section 84.33(g), does not necessarily need to be the same number

used for inspection purposes. However, the approval holder must maintain traceability between lot

numbering systems if more than one is used. For example, a shipping lot number must be traceable to the

corresponding production lot number (or numbers).

5.4 Cross-References. See MIL-STD-414 sections A5, A7.2; ANSI/ASQ Z1.9-2003 sections A2.4, A5, A7.2;

MIL-STD-105D sections 5, 7.2; MIL-STD-105E sections 3.12, 3.13, 4.3, 4.5.1; ANSI/ASQ Z1.4-2003 sections 5,

7.2; Squeglia C=0 page 2.

6. Specific Considerations for Attribute Plans

6.1 Following Arrows to Select Appropriate Sampling Plan. Where the sampling plan indicated leads to an

arrow in the table, follow the arrow to the next available sampling plan. This will point to a new code letter

row in the table with the acceptance and rejection numbers and a new corresponding sample size to be

used.

As an example, consider sampling of a lot of 200 pieces under MIL-STD-105D for a Major A characteristic at

inspection level II. Code letter G is selected from Table I, and an AQL of 1.0 is used. An arrow pointing

downward is contained in Table II-A for these conditions, indicating that code letter G is not available and
8/4/2022 SCBA and CBRN SCBA

85

code letter H must be used. This means that the appropriate sample size is 50 pieces, not 32, and that the

lot is accepted if there are 0 or 1 defective pieces, and rejected if there are 2 or more defectives.

6.2 Single, Double, or Multiple Sampling. Most attribute procedures include double or multiple sampling

plans (the Squeglia C=0 procedure only has single plans). Any of these options included in the procedure

may be selected. Note that each sample drawn must be representative of the entire lot. Double and

multiple sampling tend to require fewer samples when lot quality is either much better or much worse than

the AQL. Single sampling is simpler to administer and apply correctly than double or multiple sampling and

is the overwhelmingly popular choice.

As an example, consider a lot of 200 pieces under MIL-STD-105D for a Minor characteristic at inspection

level II. Code letter G is selected from Table I, and an AQL of 4.0 is used. For single sampling, Table II-A 

indicates that the sample size is 32. The lot is accepted if there are 3 or fewer defective pieces, and it is

rejected if there are 4 or more defectives. For double sampling, Table III-A is used instead and an initial

sample of 20 would be drawn. The lot is accepted if there are 0 or 1 defectives, and it is rejected if there are

4 or more defectives. If there are 2 or 3 defectives, then a second sample of 20 is drawn from the lot and

inspected. If after both samples (totaling 40 pieces) are inspected there are a total of 4 or fewer defectives,

then the lot is accepted; if 5 or more defectives, then the lot is rejected. Multiple sampling (Table IV-A)

works in a similar fashion, except that there are up to seven rounds of sampling to reach a decision.

6.2.1 Cross-References. See MIL-STD-105D sections 7.4, 9.5, 10.1.1, 10.1.2, 10.1.3; MIL-STD-105E

sections 4.5.3, 4.9.4, 4.10.1.1, 4.10.1.2, 4.10.1.3; ANSI/ASQ Z1.4-2003 sections 7.4, 9.5, 10.1.1,

10.1.2, 10.1.3.

7. Specific Considerations for Variable Plans

7.1 Variability Unknown vs. Variability Known. A variability unknown method should normally be used.

The variability known method may only be used when the production process is under strict control and the

process parametersinfluencing final respirator performance are well understood. Data must be provided

with the application for approval, available during on- site audits, and continuously updated to support the

standard deviation value (σ) used.

7.2 Single Specification Limit vs. Double Specification Limit. This is selected on the basis of whether there

is only one limit value (such as penetration less than or equal to 5%) or two limit values (such as cartridge

mass between 95 and 105 grams) for the characteristic.

7.3 Standard Deviation Method vs. Range Method. Either method may be selected. The standard deviation

method generally requires fewersamples, but more complex computations. 

7.4 Form 1 vs. Form 2. The two forms are equivalent and either one may be selected. Form 2 is

recommended as it yields figures which must be calculated anyway to satisfy the switching rules.

7.5 Cross-References. See MIL-STD-414 Introduction, section A6.2; ANSI/ASQ Z1.9-2003 Introduction,

section A6.2.

8. Scope
8/4/2022 SCBA and CBRN SCBA

86

8.1 Limitation to Approved Quality Control Plans. Approval holders may perform additional testing and

inspection not listed in their approved quality control plans. Sampling for these additional inspections is

not required to meet the requirements set forth in 42 CFR Part 84 and this letter. However, there must

be a reasonable basis for selecting the sampling plans used.

8.2 Limitation to Required Testing. In some cases, applicants may wish to list testing and inspection in their

quality control plans above that required by NIOSH for effective quality control of respirator performance.

Sampling done for these additional inspections is not required to meet the requirements in 42 CFR Part 84

and this letter. Additional testing should be identified clearly, such as with the notation “additional

inspection,” on documents submitted with the application to avoid delay and requests for clarification

during processing. Any such testing listed in the approved quality control plan must be conducted as

required by 42 CFR Section 84.42(c).

9. Common Errors

9.1 Selection of Inadequate Inspection Levels. The minimum acceptable inspection level is described in

section 3.2 of this letter. If a product quality control plan does not specify inspection levels, NIOSH assumes

that the level in the “normal” column of the table will be used. Use of lower levels without specific

approval, whatever the reason, is a failure to conform to NIOSH requirements and can result in revocation of

approval under 42 CFR Section 84.43(c).

9.2 Selection of Plan Based on Desired Sample Size. It is entirely improper to choose a desired sample size

and work backwards to identify a proposed AQL and inspection level which will yield this result. To do so

reflects a fundamental misunderstanding of the basis for sampling plans. The appropriate AQL and

inspection level are stated in sections 2.2 and 3.2 of this letter.

9.3 Selection of Defect Classification Based on Desired AQL. As in 9.2, the defect classification drives the

selection of AQL, not the other way around. Each defect must be classified based solely on the definitions in

42 CFR Section 84.41(d).

9.4 Modification of AQL or Inspection Level Based on Lot Size or Other Factors. The AQL and inspection level

are chosen by the criteria in sections 2.2 and 3.2 of this letter. Approval holders are free to use higher

inspection levels if greater discrimination is desired, or to use lower (more stringent) AQLs if a smaller

percent defective is desired. However, these should not be modified based on lot size or inspection history,

as provisions already exist to account for those factors. Changing AQL values or inspection levels is likely to

result in a statistically invalid plan.

9.5 Inappropriate Use of Reduced Inspection. As described in section 4.1 of this letter, reduced inspection is

permitted only when all conditions of the relevant procedure are met. When there are significant delays or

changes in production processes, approval holders must revert to normal inspection. It will be considered a 

nonconformance during NIOSH on-site audits if the records described in section 4.2 of this letter are not

available.

9.6 Incorrect Sample Size When Following 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.
8/4/2022 SCBA and CBRN SCBA

87

9.7 Improper Drawing of Samples. Each sample drawn must be representative of the entire lot as described

in section 5.2 of this letter. The typical method is to select samples at random. However, other methods

(such as every tenth piece) may be used so long as the sample is not biased in any way as a result. If a lot

contains multiple sublots, the sample must contain a proportional number of piecesfrom each sublot.

10. References

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

attributes. Milwaukee, WI: American Society for Quality, American National Standard ANSI/ASQ Z1.4-2003.

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

for percent nonconforming. Milwaukee, WI: American Society for Quality, American National Standard

ANSI/ASQ Z1.9-2003.

Squeglia NL [2008]. Zero acceptance number sampling plans. 5th ed. Milwaukee, WI: American Society for

Quality.

U.S. Department of Defense [1957]. Sampling procedures and tables for inspection by variables for percent

defective. Washington, DC: Office of the Assistant Secretary of Defense (Supply and Logistics), Military

Standard MIL-STD-414 (including Notice 1, 8 May 1968).

U.S. Department of Defense [1963]. Sampling procedures and tablesfor inspection by attributes.

Washington, DC: U.S. Government Printing Office, Military Standard

MIL-STD-105D (including Change Notice 2, 20 March 1964).

U.S. Department of Defense [1989]. Sampling procedures and tablesfor inspection by attributes.

Washington, DC: Department of Defense, Military Standard MIL-STD-105E.

For further information regarding sampling, contact Vance Kochenderfer via electronic mail at vck6@cdc.gov

or by telephone at 412-386-4029. General inquiries may be directed to the Technology Evaluation Branch at

npptl@cdc.gov or 412-386-4000.

Sincerely yours,

Heinz W. Ahlers

Chief, Technical Evaluation Branch

National Personal Protective Technology Laboratory
8/4/2022 SCBA and CBRN SCBA

88

DEPARTMENT OF HEALTH & HUMAN SERVICE Public Health Service

Centers for Disease Control

and Prevention (CDC)

National Institute for Occupational

 Safety and Health (NIOSH)

National Personal Protective

 Technology Laboratory (NPPTL)

P.O. Box 18070 

Pittsburgh, PA 15236

Phone: 412-386-4000

Fax: 412-386-4051

April 7, 2005

LETTER TO ALL RESPIRATOR MANUFACTURERS

Subject: Clarification of Supplier and Subcontractor Relationships

Background

National Institute for Occupational Safety and Health (NIOSH or the Institute) approval holders have established 

relationships with suppliers and subcontractors who are manufacturing, components or subassemblies for

approved respirator configurations. A growing number of approval holders wish to ship NIOSH-Approved

respirators directly from a subcontractor to distribution centers or customers, and replacement parts directly to

a repair center. The Institute has identified two possible approval holder relationships with suppliers and

subcontractors. Listed below are the responsibilities and requirements NIOSH has established for these

relationships. 

Definitions

Approval Holder: 

The party ofrecord to whom certificates of approval have been issued. The approval holder maintains 

responsibility for, and control of, product design, performance, configuration management, manufacture,

quality, and support.

Supplier:

A supplier produces components orsubassemblies under their own quality system for delivery to the approval

holder. The approval holder confirms the acceptability of incoming goods by accepting a Certificate of

Compliance and inspecting incoming goods to ensure compliance with all product design, performance, and

Quality Assurance criteria (drawings and engineering control). The approval holder releases the product for

distribution and sale. 

Subcontractor:

The approval holder may authorize a subcontractor to release NIOSH- approved respirators directly from their

facility for distribution and sale, or to release components and subassemblies directly to an authorized repair 

center. The approval holder maintains responsibility for, and control of, product design, performance,

configuration management, manufacture, quality, and support by maintaining influence over, and active 

involvement in, the subcontractor's quality system. As such, the subcontractor's facility is considered to be a 

manufacturing site forthe approval holder.
8/4/2022 SCBA and CBRN SCBA

89

Page 2 -Letter to All Respirator Manufacturers

Subcontractor Relationship Responsibilities

The approval documentation on file atNIOSH must demonstrate thatthe following criteria have been

met forNIOSH recognition of a subcontractor.

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

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

manufacturing processes; control overthe requirements forfinal inspection and testing; and

approval of any changesto the above.

- The approval holder must assure that a subcontractor has demonstrated the ability to supply

product that consistently meets the established release criteria, and has adequate quality

systems and procedures in place to assure product quality on an ongoing basis.

- The approval holder must establish andmaintain active involvement and influence over

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

example ofthisinvolvement and influence can be exhibited by participating 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 Review Board.

- 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

mustrepresent how the 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

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

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

significant changes, and on 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 theNIOSH Standard Application Form (SAF) for directshipment

from the subcontractor to be acceptable undertheNIOSH Approval.
8/4/2022 SCBA and CBRN SCBA

90

Page 3 - LettertoAllRespiratorManufacturers

- All manufacturing sites for NIOSH-Approved products, including subcontractor facilities, will

be audited by NIOSH on a regular basis. The Institute will not contact the subcontractor

directly, but will always work through the approval holder's designated representative for

the specific manufacturing site.

Sincerely yours,

Heinz W. Ahlers 

Acting Branch Chief

Respirator Branch

National Personal Protective Technology Laboratory
8/4/2022 SCBA and CBRN SCBA

91

Definitions 

The following definitions are provided for clarification of terms used in these procedures:

Accessory - An item provided with a respirator that does not affect the respirator’s ability to meet the 

requirements of 42 CFR Part 84. The approval remains effective whether or not the accessory is used.

Alternate Contact - A contact designated by the prospective approval holder that can interface with 

NIOSH regarding applications and other NIOSH business such as audits and product investigations. 

Amended Application - An application submitted at NIOSH’s request that shows changes to correct an 

inaccuracy detected during the NIOSH application evaluation. The Applicant-Assigned Reference 

Number (AAR#) and Task Number (TN) will remain the same. 

Applicant - The individual, partnership, company, corporation, association or organization that designs, 

manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate 

of approval for such respirator.

Applicant-Assigned Reference Number (AAR#) - A unique identifying number of the applicant’s 

choosing. The number must start with the three character manufacturer’s code. The AAR# must never 

be reused.

Approval - A certificate or formal document issued by the Institute (in this instance NIOSH) stating that 

an individual respirator or combination of respirators has met the minimum requirements of this part

(42 CFR 84), and that the applicant is authorized to use and attach an approval label to any respirator, 

respirator container, or instruction card for any respirator manufactured or assembled in conformance 

with the plans and specifications upon which the approval was based, as evidence of such approval.

Approval Holder - The entity to which a certificate or formal document has been issued by NIOSH 

stating that an individual respirator or combination of respirators has met the minimum requirements 

of 42 CFR Part 84. The approval holder is authorized to use and attach an approval label to any 

respirator, respirator container, or instruction card for any respirator manufacturers or respirator 

assembled in conformance with the plans and specifications upon which the approval was based.

Approval Labels - The label that is attached to the respirator, container, instructions, or packaging 

once approved by NIOSH. All major subassemblies in the approved respirator configuration must be 

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

Assembly Matrix - A diagram of all major subassemblies and accessories that apply to approvals in a 

respirator family. Components are identified by category, description, drawing number and revision, 

part number, and applicability to the listed approvals.

Authorized Representative - The person responsible for completing and submitting the Standard 

Application Form to NIOSH. This person can be an employee of the prospective approval holder or an 

independent consultant hired by the company to complete the Standard Application Form. Designated 
8/4/2022 SCBA and CBRN SCBA

92

by prospective approval holder to interface with NIOSH regarding applications and other NIOSH 

business such as audits, and product investigations. 

Belt Mounted - An air-purifying canister, chemical cartridge, or particulate filter or an air-supplied 

regulating valve or regulator that is mounted on the user’s belt with an adaptor.

Canister - A gas or vapor removing component which meets the requirements of 42 CFR Part 84, 

subpart I, Tables 5, 6, and 7 only. Canisters may incorporate particulate filters and can be used for 

escape from immediately dangerous to life or health environments, which sufficient oxygen. Usually 

approved with under schedule 14G respirators.

Cartridge - A gas or vapor removing component which meets the requirements of 42 CFR Part 84, 

subpart L, Table 11. Cartridges may incorporate particulate filters. Cartridges cannot be used in 

immediately dangerous to life or health environments and are usually part of 84A or 23C approval 

schedules.

Chest and Back Mounted - Canisters fastened to a user’s body, either on the back or chest, that have a 

breathing tube running from the canister to the facepiece inlet. 

Chin Mounted - A canister, cartridge, or filter mounted on the full facepiece. Chin-style gas masks 

typically have a medium-sized (250-500 cm3) canister rigidly attached to a full facepiece.

Combination Particulate Filtering and Gas/Vapor Removing - Cartridges and canisters that protect the 

user from both particulates and gases and vapors.

Common Assembly Matrix - An assembly matrix (diagram) that contains all of the information for a 

series of applications. A common assembly matrix should be found in the last application of the series. 

Also, a suggested processing order and an explanation as to how the applications interrelate must be in 

the Approval History, if applicable. In addition, assembly matrices should not contain information for 

future submissions. (See “Series of Applications”). 

Component - Essential parts to a respirator that provide function and effective performance of the 

product. (See “Major Subassemblies”). 

Controlled Document - Documents signed, released, and placed in an applicant’s document control 

system.

Correlation Testing - Testing conducted to compare an applicant’s test equipment and results to 

NIOSH’s. The applicant must submit a new application with the wording “Correlation testing only; 

respirator is not submitted for approval” in the “Reason for Application” section. 

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. 
8/4/2022 SCBA and CBRN SCBA

93

As defined in 42 CFR Part 84: “Critical” A defect that judgement and experience indicate is likely to 

result in a condition immediately hazardous to life or health for individuals using or depending upon 

the respirator.

Critical User Instructions - Instructions that are important to operate a particular respirator. For 

instance, checking the service life indicator on a CCER is a critical user instruction.

Delist - Respirator listing is removed from the Certified Equipment List when NIOSH approval is 

rescinded or revoked.

Design - The overall specification for the respirator that includes materials, physical envelope and 

shape, manufacturing processes, and Quality Assurance requirements.

Discontinued - See obsolete.

Exploded-View Drawing - A drawing of the complete respirator assembly showing all major 

subassemblies and accessories and their proximity to one another.

Family of Products - A group or series of respirators sharing a common major subassembly, such as a 

facepiece or regulator. The applicant determines the basis for the respirator families. 

Facepiece - A respirator component designed to provide a gas-tight or dust-tight fit with the face and 

may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas 

source.

Facepiece Mounted - A canister, cartridge, or filter mounted on the facepiece. 

Features - Descriptors that relate to the makeup, shape, proportions, outward appearance, prominent 

characteristics, or qualities of the part, but are not separate components or devices. Do not list 

features on the approval label (e.g., “super-soft face seal”).

Filter - A particulate removing component of a respirator which meets the requirements of

42 CFR Part 84, subparts K or KK. 

Field-Replaceable - Any component, major subassembly, or accessory (e.g., cartridges, hoses, 

regulators) that can be replaced by the user following the manufacturer’s User Instructions without 

any special knowledge, skills, abilities, or equipment. 

Filtering Facepiece - An N, R, or P class particulate respirator where the entire facepiece is composed 

of the filtering media. The unit may have an exhalation valve, but has no replaceable parts. 

Full Facepiece - A type of facepiece that covers a user from the hairline to below the chin. 

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

and vapors.
8/4/2022 SCBA and CBRN SCBA

94

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

from toxic materials.

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

manufacturing processes.

Hazardous Atmosphere - Any atmosphere that contains toxic or disease producing gas, vapor, dust, 

fume, mist, or pesticide, that is either immediately or not immediately dangerous to life or health. 

Also, any oxygen-deficient atmosphere.

Helmet - A rigid protective headgear incorporated into the design of a respirator that covers the user’s 

head and possibly the user’s neck. 

Helmet Mounted - A canister, cartridge, or filter mounted on the helmet. 

Hood - A light, flexible device covering only the head and neck, or head, neck, and shoulders of a user.

Hood Mounted - A canister, cartridge, or filter mounted on the hood. 

Immediately Dangerous to Life or Health - Conditions that pose an immediate threat to life or health 

or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive 

materials, which are likely to have adverse cumulative or delayed effects on health.

Inactive - See obsolete.

Intrinsically Safe - Not capable of releasing enough electrical or thermal energy under normal or 

abnormal conditions to cause ignition of a flammable mixture such as methane or natural gas or air 

comprised of an easily ignitable composition.

Major Subassemblies - Those components or subassemblies (1) that are essential to the respirator’s 

function and effective performance; (2) that affect the respirator’s performance or design; and (3) 

which are field-replaceable items. 

Manufacturer’s Code - A unique three-letter code assigned to each approval holder by NIOSH.

Model Number - An identifier of a product given by the manufacturer. A model number is not 

required to identify each unique configuration. 

Mouthpiece - A respirator component that is held in the teeth with a clamp to close the nostrils that 

provides a gas-tight or dust-tight fit with the mouth. 

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.
8/4/2022 SCBA and CBRN SCBA

95

Not Immediately Dangerous to Life or Health - Any hazardous atmosphere which may produce 

physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse 

physiological symptoms after prolonged exposure.

Nuisance Level Contaminants - Contaminants where the concentration in the atmosphere is below the 

established PEL (OSHA permissible exposure limit) or REL (NIOSH recommended exposure limit), 

whichever is lower. Nuisance level protection capability is not evaluated by NIOSH. 

Obsolete - A respirator is considered obsolete when it is no longer manufactured or supported by the 

approval holder. However the NIOSH approval is still listed and the respirators can still be used until 

the units can no longer be maintained in an approved configuration. Approval remains active and is 

shown in the CEL as obsolete.

Part Number - The unique number referenced by users to identify respirator parts. The identifying 

number located on the component must match the part number shown on all labels (abbreviated and 

full) and on the assembly matrix. The location of the part number on the component hardware must 

be shown on the drawings. Applicants sometimes refer to the part number as catalog number, 

manufacturer number, production component number, among other terms. 

Particulate Filtering Respirator - A type of respirator that protects users against solid particles or 

liquids such as dusts, fumes, and mists by trapping the particles with its fibers. The filters are classified 

by NIOSH as N, R, or P accompanied by either 95 (95%), 99 (99%), or 100 (99.97%) to indicate filtration 

levels.

Permissible Exposure Limit (PEL) - An OSHA permissible exposure concentration limit based on health 

data evaluation. Users working in contaminate levels below this concentration are not required by 

OSHA to have respiratory protection.

Pre-filter - An accessory item situated in front of the approved filter that removes coarse particles but 

does not meet 42 CFR Part 84 criteria for particulate filters. A pre-filter is a filter often used prior to an 

N-, R-, or P-series filter or cartridge. Pre-filters are not classified as N-, -R, or P-series filters. When prefilters are used, the complete assembly must meet the resistance requirements of 42 CFR Part 84. Prefilters may be listed on the approval labels. If shown on the approval label, pre-filters must be listed as 

an accessory and designated as a pre-filter.

Pre-Submission Test Data - Respiratory performance test data must accompany each application and 

must specify components used for test configuration by part number, show units of measure for all 

test data (matching 42 CFR Part 84 criteria), and submit copies of actual test data with all results and 

conclusions. 

Performance - The actual operational performance of the respirator with respect to the applicable 

regulations and design parameters. The respirator must meet or exceed the requirements of the 

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

(STPs) as appropriate to the type of respirator. 
8/4/2022 SCBA and CBRN SCBA

96

Primary Contact - The person designated by the prospective approval holder to receive all official 

NIOSH correspondence, including but not limited to approval and denial letters, manufacturers 

meeting notices, and notices seeking input for standards development. If this person changes, it is the 

responsibility of the manufacturer to notify NIOSH, in writing, of the person taking over this 

responsibility. The preference is for the Primary or Alternate Contact to make the notification to 

NIOSH prior to the change. Alternatively, a corporate officer may notify NIOSH.

Private Label - A respirator labeled as belonging to an organization that is not the approval holder. 

Private-labeled respirators are assigned the same TC number issued to the approval holder for the 

original product. Only the approval holder can apply for a private label.

Private Packaging - A respirator that is repackaged and sold by a company that is not the approval 

holder. All part numbers, model numbers, and approval labels must be the same as those approved by 

NIOSH. However, the packaging may reference the packaging company instead of the approval holder. 

The approval holder is responsible for ensuring that private packaging arrangements do not mislead 

the end user. 

Product Quality Control Plan (PQP) - Summarizes the manufacturing, inspection, test operations, and 

applicable documents used in regular production of a specific respirator family.

Product Trade Name - A name that uniquely identifies a respirator or respirator family. A product 

trade name is required because of the way approval holders market and users reference certified 

respirators. The product trade name must not imply use for a specific hazard.

Protection - A different type of protection is defined as protection against a different atmospheric 

contaminant (e.g., particulates, chlorine gas, ammonia gas, mercury vapor, etc.). A different level of 

protection is defined by a change in the type of facepiece (half-mask, full facepiece) or mouthpiece, 

filtering efficiency (such as N95 as opposed to N100), and/or the air supply capability (e.g., pressure, 

duration, demand flow, continuous flow, etc.).

Prototype - Defined as a respirator or component that (a) involves a new design produced using rapid

prototyping methods, temporary tooling, non-production tooling, or regular production tooling in a 

new fashion, and (b) has demonstrated by the applicant’s pre-testing to meet 42 CFR Part 84 minimum 

design and performance requirements. Respirators may not be submitted for approval while in this 

defined prototype stage (limited production tooling and processes). NIOSH will request samples made 

on regular production tooling and production quality control (Ref. 84.30 (c)) if the approval holder 

request approval. For non-approval prototype testing use a new application form and state “Prototype 

Testing Only - Respirator is Not Submitted for Approval” in the “Reason for Application.”

Quality Assurance (QA) - A planned and systemic pattern of all activities necessary to provide 

confidence that all respirators will perform satisfactorily in operation.

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

organizational structure, responsibilities, procedures, processes, and resources for implementing 
8/4/2022 SCBA and CBRN SCBA

97

quality management and policy. Hard copies with original approval signatures need submitted and will 

be retained in NIOSH’s files.

Quarter-Mask - A type of facepiece that covers the mouth and nose where the lower sealing surface 

rests between the mouth and chin. Quarter-masks are most commonly found on dust and mist 

respirators. 

Recommended Exposure Limit (REL) - A NIOSH recommended exposure concentration limit based on 

health data evaluation. Users working in contaminate levels below this concentration are not required 

by OSHA to have respiratory protection.

Regular Production Unit - A respirator or component made on regular production tooling, or that is 

identical to units made using regular production tooling, and is not made with any operations that will 

not be included in regular production.

Rescission - The approval holder voluntarily requests the certificate of approval be withdrawn for a 

product. The approval is no longer valid. Respirators in the field are no longer NIOSH-Approved. 

Respirators are not listed in the CEL.

Respirator - Any device designed to provide the wearer with respiratory protection against inhalation 

of a hazardous atmosphere.

Resubmission of an Application - Resubmission of a previously denied application. Resubmitted 

applications receive a new task number (TN) and are placed at the end of the application processing 

queue. All documentation must be updated to the current dates and revision levels.

Revocation - NIOSH reserves the right to revoke, for cause, any certificate of approval issued pursuant 

to the provisions of 42 CFR Part 84. Such causes include, but are not limited to, misuse of approval 

labels and markings, misleading advertising, and failure to maintain or cause to be maintained the 

quality control requirements of the certificate of approval. The approval is no longer valid. Respirators 

in the field are no longer NIOSH-Approved. Respirators are not listed in the CEL.

SEI Retrofit - An update or correction to a suspected performance or design issue to a Self-Contained 

Breathing Apparatus (SCBA) that is approved by NIOSH and the Safety Equipment Institute. This type 

of SCBA is approved jointly by NIOSH and SEI for use in firefighting operations. 

Series of Applications - A series of associated applications submitted at the same time (in the same 

bundle or package). A common assembly matrix that contains all of the information for the submitted 

series is located in the last application of the series. Assembly matrices must not contain information 

regarding future submissions. 

Service Life Plan - A document that contains information on the reliability engineering methodology 

and appropriate service life dates that users may rely on for determining safe and reliable performance 

of the respirator under intended use conditions.
8/4/2022 SCBA and CBRN SCBA

98

Simplified Drawings - Exploded-view and major subassembly drawings that accompany the 

application. Any additional drawings necessary for clarification of a major subassembly or part may 

also be included.

Standard Application Form (SAF) - The electronic form used to submit respirator approval requests to 

NIOSH.

Subcontractor - The entity contracted to produce products under the direction/oversite of the 

prospective approval holder.

Supplier - The entity that produces components or subassemblies under their own quality system for 

delivery to the approval holder.

User Instructions - Detailed instructions provided to the user that describes how to properly inspect, 

don, and use the product.
8/4/2022 SCBA and CBRN SCBA

99

ACRONYMS

AAR# - Applicant Assigned Reference Number

ABMS - Automated Breathing Metabolic Simulator

AP - Air-Purifying 

APRS - Air-Purifying Respirator Section

AQL - Acceptable Quality Level

AS - Air-Supplied

ASR - Air-Supplied Respirator (See SAR)

BMS - Breathing Metabolic Simulator 

CAR - Corrective Action Request

CBRN - Chemical, Biological, Radiological, and Nuclear

CCER - Closed-Circuit Escape Respirator

CEL - Certified Equipment List

CFR - Code of Federal Regulations

CGA - Compressed Gas Association

CV&SDB - Conformity Verification and Standards Development Branch

EBSS - Emergency Breathing Support System

EIN - Employer Identification Number

ESLI - End-of-Service-Life Indicator

EOSTI - End-of-Service-Time Indicator

ETB - Evaluation and Testing Branch

HHS - Department of Health and Human Services

HSBG - Human Subject Breathing Gas
8/4/2022 SCBA and CBRN SCBA

100

IDLH - Immediately Dangerous to Life or Health

LRPL - Laboratory Respirator Protection Level

MSHA - Mine Safety and Health Administration (Department of Labor)

NFPA - National Fire Protection Association

NIOSH - National Institute for Occupational Safety and Health

NPPTL - National Personal Protective Technology Laboratory

OSHA - Occupational Safety and Health Administration (Department of Labor)

PAPR - Powered Air-Purifying Respirator

PEL - Permissible Exposure Limit (OSHA)

PQP - Product Quality Control Plan

QA - Quality Assurance

REL - Recommended Exposure Limit (NIOSH)

RPD - Respiratory Protective Devices

RPU - Regular Production Unit

SAF - Standard Application Form

SAP - Standard Application Procedure

SAR - Supplied-Air Respirator

SCBA - Self-Contained Breathing Apparatus

SCP - Standard Conditioning Procedure

SCSR - Self-Contained Self-Rescuer

SEI - Safety Equipment Institute

SOP - Standard Operating Procedure

STP - Standard Test Procedure
8/4/2022 SCBA and CBRN SCBA

101

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

TN - Task Number; a unique number assigned by NIOSH to each application
8/4/2022 SCBA and CBRN SCBA

102

Revision History 

Date Section Action

8-Jan-18

Section 1

1.1.9 Submitting 

Test Samples

First paragraph, third sentence. Changed: cylinder pressure to 

pressure reducers, 

Added second paragraph: All sample components must be 

identified and labeled with the corresponding part number as 

listed on the assembly matrix.

8-Jan-18

Section 1

1.2.2

Extensions of 

Approval 

Application

Added second paragraph under second drawing: This includes 

any minor changes to any document that is part of the approval 

record. These changes should be submitted for an extension of 

approval at your earliest convenience. NOTE: documents not upto-date in the NIOSH record could be identified during a site 

audit and result in a non-conformance.

8-Jan-18

Section 1

1.2.3

Quality Assurance 

Approval 

Application

First bullet Changed from: Used for new or updated Quality 

Assurance (QA) Manuals only.

To Current NIOSH approval holders may use this type of 

application to submit new or updated Quality Assurance (QA) 

Manuals. This type of application is limited to current approval 

holders.

8-Jan-18 Section 2

9 (Section C.9)

Reason for 

Application

Third paragraph. Added: Also list the Corrective Action Request 

(CAR) number associated with the application.

8-Jan-18

Section 2

11 (Section C.11)

Description of 

Respirator

After the 11th entry - If the respirator contains electrical 

components ... Added: NOTE: If the respirator is to be used 

in underground mines or for mine rescue and has 

electronics, MSHA intrinsic safety approval must be 

received prior to submitting to NIOSH.

8-Jan-18 Section 2

12 (Section C.12)

Intended Protection 

and Safety Design 

End of second paragraph. Added: In addition, if the respirator 

has electronic components, MSHA intrinsic safety approval must 

be received prior to submitting to NIOSH.

8-Jan-18 Section 2

13 (Section C.13)

Pre-Submission 

Performance Test 

Data and 

Statements Second paragraph. First line. Deleted: ESLI

8-Jan-18

Section 2

15 (Section C.15)

Test Samples

Third paragraph, second sentence. Added: as it is listed on the 

assembly matrix
8/4/2022 SCBA and CBRN SCBA

103

8-Jan-18 Section 3

3.1 Quality 

Assurance 

Documentation

Second paragraph. Third sentence. Added: in a separate QA 

Application,

8-Jan-18

Section 3

3.5 Combination 

Supplied-Air 

Respirators and 

SCBA ...

Paragraph under Test Fees to be Charged for New and 

Unspecified Tests: Deleted: Do not issue a single payment 

(check or pay.gov) for multiple invoices. Separate payments 

(check or pay.gov) are required for each application invoice 

received. Include the AAR# on the payment so it is properly 

credited.

Added: A single payment (check or pay.gov) for multiple 

invoices is allowed. Include the AAR#s for each associated 

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

properly credited. Separate payments (check or pay.gov) will 

also be allowed for each application invoice. For application fee 

invoices, include the TN number(s) associated with the 

payment. To indicate a final payment for a specific 

application(s), add an -F after the TN number(s) (TN-nnnn-F).

8-Jan-18 Section 3

3.6

Annual (Fixed) Fees 

... Deleted: Only one application per check.

8-Jan-18 Section 3

3.8

Drawings for SCBA 

...

Fourth sentence Deleted: However, it is suggested that 

applicants also use their three character manufacturer’s code in 

drawing filenames (XXXnnnnRa.dwg).

8-Jan-18

Section 3

3.12

List of NIOSH 

Cautions ...

End of cautions and limitations. Added: If the respirator 

contains electrical components and the applicant wishes to list 

the respirator on the NIOSH approval label as intrinsically safe, 

intrinsic safety approval must be received from MSHA under Title 

30 CFR Part 18 or a recognized independent laboratory. 

Verification of such approval must be submitted with the 

application. If the respirator is for underground use, MSHA 

intrinsic safety approval must be received prior to submitting to

NIOSH.

8-Jan-18 Section 3

3.13 

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

8-Jan-18 Section 3

3.14

User Instructions

Second sentence. Added words. Sentence now reads. User 

Instructions must be listed on the assembly matrix for SelfContained Breathing Apparatus, and are required.
8/4/2022 SCBA and CBRN SCBA

104

8-Jan-18 Section 3

3.14

User Instructions Sixth paragraph. Added: under a Special "S" titled listing: 

12-Mar-18

Section 3

3.16

Summary of 

Related Documents

Added at the end: In addition to the application file, the 

manufacturer must submit related project documents. These 

documents must be in English and saved with the following filenaming conventions. Any files created in a language other than 

English will be returned unprocessed.

8-Jan-18 Section 3

3.17

File Naming 

Conventions

 Added an additional bullet: NIOSH will only accept single 

documents under a single filename. Multiple documents under a 

single filename will not be accepted and the application may be 

denied.

8-Jan-18

Section 4

4.4

Denial of a Project 

Undergoing NIOSH 

Evaluation

8th bullet. Deleted: a filter media and alternate. Added: a

SCBA unit for entry and escape and an alternate unit for escape 

only. Now reads: The official submittal either (1) requested 

approval of two respirators of different basic designs (includes 

submitting a SCBA unit for entry and escape and an alternate 

unit for escape only in the same application) 

8-Jan-18

Section 4

4.4

Denial of a Project 

Undergoing NIOSH 

Evaluation

11th bullet: added with MSHA intrinsic safety. Now reads: 

Protection or intended use claims have not been requested or 

approval has not been obtained from other governing agencies 

(such as MSHA for mine use with MSHA intrinsic safety or 

intrinsic safety from recognized laboratories).

8-Aug-22 Section 5

Test Selection 

Guide for SelfContained

Breathing

Apparatus and 

CBRN SelfContained 

Breathing 

Apparatus Updated: Correct links to STPs

8-Jan-18

Section 6

6.1 NIOSH 

Respirator 

Application 

Checklist

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

8-Jan-18

Section 6

6.1 Private Label 

Checklist ...

Item 28. Changed to: The harness labels, primary company, 

and private label company, if applicable, are listed and shown on 

page two of the applicable drawings.

8-Jan-18 Section 6

6.2 Exploded-view 

Drawing Checklist ... Item 1: Added: (as required).
8/4/2022 SCBA and CBRN SCBA

105

8-Jan-18 Section 6

6.5 

Respiratory Inlet 

Covering

Item 1. Second sentence. Changed from: Does not apply to 

types B, BE, C, and CE.

To: Does not apply to types A, AE, B, and BE.

8-Jan-18 Section 6

6.6 Private Label 

Checklist ...

Item 5A. Added: /Harness

Item 5A.c. Added numbers(s)

8-Jan-18 Section 6

6.7 Assembly 

Matrix ...

Item 7: Deleted Nuisance OV.

Added: Quick Attachment cylinder.

8-Jan-18 Section 8

Label Format 

Guidance

Bullet 12 Added second sentence: Protections are to include 

the End-of-Service-Time Indicator version (EOSTI-25 or EOSTI33).

8-Jan-18 Appendix

Acronyms Added: CAR - Corrective Action Request