NIOSH Conformity Assessment Notice

NIOSH CA 2019-1012

February 2019

 

NIOSH Respirator Approval Contents and Meaning 

Supersedes

March 17, 2006 Respirator User Notice – Meaning of NIOSH Approvals

May 15, 2015 Letter to All Respirator Manufacturers – NIOSH Respirator 

Certificate of Approval, Approval Labels and User Instructions
Document Number

NIOSH CA 2019-1012

Page 2 of 4

1 SUMMARY

The National Institute for Occupational Safety and Health (NIOSH) is providing this notice to 

consolidate and update information about the content and meaning of a NIOSH respirator approval. 

NIOSH issues certificates for approvals for respiratory protective devices under the provisions of Title 

42, Code of Federal Regulations, Part 84 (42 CFR Part 84). NIOSH will issue approvals only for complete 

respirator assemblies or combination respirator assemblies (configurations) that meet the minimum 

requirements set forth in the regulation. Only the NIOSH approval holder is authorized to use the 

NIOSH approval label, and that holder is obligated to define proper use and maintenance procedures, 

maintain the production quality, and provide replacement parts in accordance with the approval. Only 

those maintainance procedures deemed appropriate and identified by the approval holder are viewed 

as acceptable in maintaining conformance of the respirator assembly.

NIOSH approval holders communicate NIOSH-approved configurations to the user community and 

other affected parties through NIOSH-approved labels and related user instructions. The labels and 

user instructions serve as notifications that the products listed are NIOSH-approved and document 

approved configurations, protections, and any pertinent cautions and limitations with regard to use. 

The NIOSH approval labels list the major subassemblies (parts) that belong to the approved respirator 

configurations. If any major subassembly has user-replaceable components that are not listed on the 

approval labels, they must be identified (by part number) in the user instructions. The user instruction 

manuals are controlled documents that are maintained as part of the approval and listed on the 

approval label for most types of NIOSH-approved respirator assemblies. 

A NIOSH approval applies only to the respirator as tested and the documents provided for NIOSH 

review and acceptance in accordance with 42 CFR Part 84, NIOSH Standard Application 

Procedures (listed below), and Letters to Interested Parties or Respirator Manufacturers. NIOSH 

has updated the Letter format is now providing information as Conformity Assessment Notices, 

Subject: NIOSH Respirator Approval Contents and Meaning 

Supersedes

March 17, 2006 Respirator User Notice – Meaning of NIOSH Approvals

May 15, 2015 Letter to All Respirator Manufacturers – NIOSH Respirator Certificate 

of Approval, Approval Labels and User Instructions
Document Number

NIOSH CA 2019-1012

Page 3 of 4

including Conformity Assessment Interpretation Notices, and Conformity Assessment Letters to 

Manufacturers. 

2 AUTHORITY

42 C.F.R. Part 84, Respiratory Protective Devices

3 BACKGROUND and SUPPLEMENTAL INFORMATION

Quality Assurance:

The respirator manufacturer’s quality control plans are reviewed and must be determined to be 

satisfactory, in accordance with 42 CFR Part 84, to achieve and maintain the NIOSH approval (see §§

84.33(f), 84.40, 84.41, 84.42, 84.43). The provisions include regular audits of the Approval Holder’s 

products and manufacturing sites. A NIOSH approval applies only to the specific respirator that 

consists of the components included on the NIOSH approval label. The issuance of an approval 

number to a respirator manufacturer does not signify that every respirator built within that 

manufacturer's facility is also NIOSH-approved.

Performance Testing:

Complete and specific respirator assemblies or configurations are approved after the respirator has 

been evaluated in the laboratory and found to comply with all relevant performance requirements. 

Testing completed to achieve NIOSH approval is specific to the respirator type. This includes nonpowered and powered air-purifying respirators, or atmosphere-supplying respirators such as selfcontained breathing apparatus and supplied-air respirators, and the protections offered. 

Certificate of Approval:

A NIOSH certificate for approval applies only to the respirator as tested, and additions or modifications 

that may affect the performance and design will void the approval. When NIOSH issues an approval, 

the approval package includes specific electronic files identifying the contents of the approval label or 

labels and the approved respirator assembly, including the user instructions. The approval labels and 

user instructions provided to the user serve as notification that the products listed are NIOSHapproved and document approved configurations, protections, and ensure appropriate communication 

of pertinent cautions and limitations with regard to use. They are part of the approved respirator 

configuration (see §§ 84.31, 84.33(a), 84.33(b)).
Document Number

NIOSH CA 2019-1012

Page 4 of 4

4 REFERENCES

Approval of Respiratory Protective Devices, 42 C.F.R. Part 84

Standard Application Procedure for the Approval of Air-Purifying Filtering Facepiece Respirators Under 

42 CFR Part 84, revised March 12, 2018, Section 3.1 and 3.2

Standard Application Procedure for the Approval of Closed-Circuit Escape Respirators Under 42 CFR 

Part 84, revised October 16, 2018, Section 3.1 and 3.2

Standard Application Procedure for the Approval of Supplied-Air Respirators, Industrial SelfContained Breathing Apparatus, and Combination Supplied-Air Respirators/Industrial Self-Contained 

Breathing Apparatus Under 42 CFR Part 84, revised March 12, 2018, Section 3.1 and 3.2

Standard Application Procedure for the Approval of Powered Air-purifying Respirators and Chemical, 

Biological, Radiological and Nuclear Powered Air-Purifying Respirators Under 42 CFR Part 84, revised 

March 12, 2018, Section 3.1 and 3.2

Standard Application Procedure for the Approval of Air-purifying Respirators and Chemical, Biological, 

Radiological and Nuclear Air-Purifying Respirators Under 42 CFR Part 84, revised March 12, 2018,

Section 3.1 and 3.2

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 March 12, 2018, Section 3.1 and 3.2