Respirator Approval Information
How to apply for NIOSH Respirator Approval
The National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program frequently receives questions from manufacturers, distributors, and designers related to NIOSH respirator approval applications. Frequently, NIOSH is not able to approve an application because achieving NIOSH approval requires implementing a robust quality management system in addition to meeting performance requirements. This booklet provides an overview of the NIOSH approval process and the application package requirements to address the most frequently asked questions, deter inappropriate applications, and better prepare potential NIOSH approval holders for the application process.
NIOSH has returned to conventional operations in relation to respirator approval applications. Please see NIOSH Conformity Assessment Letters to Manufacturers, NIOSH CA 2023-1061, for more information about application prioritization.
Applicants should review NIOSH CA 2021-1034R1 for guidance on NIOSH’s review process.
The first step in the approval process is for the entity that controls the design or manufacturing of the respirator to request a Manufacturer’s Questionnaire from RecordsRoom@cdc.gov.
After completing this questionnaire, NIOSH will review the information provided and, if the responses are satisfactory, assign a 3-letter manufacturer code. This code does not imply NIOSH approval; however, applicants must obtain this code before you can submit a formal respirator approval request.
Once you obtain a manufacturer code, NIOSH will send you the Standard Application Form to submit a single approval request for a new respirator. All required documentation (including the Quality Manual), test samples, and appropriate fees, as detailed in the Standard Application Procedures, must be provided. Links to the Standard Application Procedures are below.
NIOSH 42 CFR Part 84, Approval of Respiratory Protective Devices
This rule addresses NIOSH approval requirements for respiratory protective devices.
Standard Application Procedures (SAP)
- SAP for the Approval of Closed-Circuit Escape Respirators Under 42 CFR Part 84 [PDF – 1.55 MB], updated August 4, 2022
- SAP for the Approval of Supplied-Air Respirators, Industrial Self-Contained Breathing Apparatus, and Combination Supplied-Air Respirators/Industrial Self-Contained Breathing Apparatus [PDF – 1.66 MB], updated August 4, 2022
- SAP for the Approval of Powered Air-Purifying Respirators and Chemical, Biological, Radiological, and Nuclear Powered Air-Purifying Respirators [PDF – 1.05 MB], updated August 4, 2022
- SAP for the Approval of Air-Purifying Respirators and Chemical, Biological, Radiological, and Nuclear Air-Purifying Respirators [PDF – 2.29 MB], updated August 4, 2022
- SAP for the Approval of Self-Contained Breathing Apparatus and Chemical, Biological, Radiological, and Nuclear Self-Contained Breathing Apparatus [PDF – 1.45 MB], updated August 4, 2022
- SAP for the Approval of Air-Purifying Filtering Facepiece Respirators [PDF – 1.21 MB], updated June 29, 2022.
NOTE: Applicants should review the entire document and contact the Records Room at RecordsRoom@cdc.gov or 412-386-4000 with any questions before submitting a respirator for approval.
All new applicants should read through the NIOSH Conformity Assessment Notices prior to submitting an application to become more familiar with the process.
Fees
Respirator Certification Fees Final Rule effective May 26, 2015
Respirator Certification Fees, Questions, and Answers [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
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 Fees [PDF – 58 KB]
This policy document provides 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 Policy [PDF – 69 KB]
This policy document clarifies 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
This guidance provides the color-coding requirements of labels for canisters and cartridges as a means for secondary identification.
Respirator Certification Program Decision Review Process [PDF – 593 KB], dated January 30, 2008
This document describes the structured process that enables stakeholders to request a review of decisions related to NPPTL policy statements, test procedures, and test results pertaining to ongoing respirator certification activities.