Respirator Approval Information

How to apply for NIOSH Respirator Approval

As announced at the November 16, 2016 meeting for all manufacturers, Conformity Verification and Standards Development Branch is releasing SAF V9 for optional use. When using SAF V9, you will no longer need to have Java installed on your PC to fill out applications. While SAF V9 will require some additional information in applications for new approvals, we believe the overall process will be improved offering benefits in greater accuracy and quicker processing in some circumstances. SAF V8 is still the official version of the application software, but if you wish to try SAF V9, please contact the Records Room and let us know you would like to try a copy of SAF V9. We are soliciting comments on all aspects of its operation, so we encourage you to share your observations with us.

NIOSH 42 CFR Part 84, Approval of Respiratory Protective Devicesexternal icon
This rule addresses NIOSH approval requirements for respiratory protective devices.

Standard Application Form for the Approval of Respirators

NIOSH Standard Application Form Module 1: Applying for a Manufacturer Codepdf icon
This tutorial is intended for manufacturers who are new to the NIOSH respirator approval application process. It is meant to clarify how to obtain a three-character manufacturer code, which is the first step in the application process.

NIOSH Standard Application Form Module 2: Applying for a New FFR Approval pdf icon
In this training module we discuss how to fill out the NIOSH Standard Application Form (SAF v9) for a new respirator approval. The application demonstrated in this module is specific to an air-purifying filtering facepiece respirator (FFR).

Standard Application Procedures (SAP)

NOTE: Applicants should review the entire document and contact the Records Room at RecordsRoom@cdc.gov or 412-386-5320 with any questions before submitting a respirator for approval.

Fees

Respirator Certification Fees Final Rule effective May 26, 2015

Respirator Certification Fees, Questions, and Answerspdf icon [PDF – 126 KB], June 15, 2015

Fees for Chemical Warfare Agent (CWA) Testing Portion of Chemical, Biological, Radiological, and Nuclear (CBRN) Approval, effective September 1, 2014

Logos

DHHS, NIOSH, and CBRN Logos for use by approval holders on labels for NIOSH-approved respirators.

NIOSH-Approved Chemical, Biological, Radiological, and Nuclear Agents (CBRN) Logopdf icon [PDF – 9 KB]

Standard Testing Procedures

Standard Testing Procedures (STPs)
Each respirator and component submitted for approval must meet the applicable requirements outlined in 42 CFR Part 84 subparts H through L. The standard testing procedures used by NIOSH are listed in this section.

Other Information

Policy Supporting the Collection of NIOSH Approval Feespdf icon [PDF – 58 KB]
This policy document is intended to provide specific implementation guidance and interpretation to support fee collections in accordance with the requirements of Title 42 Code of Federal Regulations (42 C.F.R.), Part 84, Subpart C–Fees.

Long-term Field Evaluation Policypdf icon [PDF – 69 KB]
This policy document is intended to clarify the application of Title 42 Code of Federal Regulations (42 CFR) § 84.310, “Post-approval testing,” paragraph (c), by offering a more precise explanation of the tests the National Institute for Occupational Safety and Health (NIOSH) expects to perform in fulfillment of this requirement.

Colors for Respirator Element Labeling, dated January 17, 2008
The color coding requirements of labels for canisters and cartridges as a means for secondary identification.

Respirator Certification Program Decision Review Processpdf icon [PDF – 593 KB], dated January 30, 2008
A structured process that enables stakeholders to request a review of decisions regarding NPPTL policy statements, test procedures, and test results pertaining to ongoing respirator certification activities.

Page last reviewed: May 14, 2019