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NIOSH

For Respirator Manufacturers

Workers wearing respirator protection

Approval Support, Test Procedures, Standards, and User Notices

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 Devices
This rule addresses NIOSH approval requirements for respiratory protective devices.

Standard Application Form for the Approval of Respirators, Version 7

NIOSH Standard Application Form Module 1: Applying for a Manufacturer Code
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.

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 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

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) Logo [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 Fees [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 Policy [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 Process [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.

Respirator User Notices

Notices are provided to inform users of a condition or risk that may exist with a NIOSH-approved product.

NIOSH and MSHA Investigation of CSE SR 100 Starter Oxygen Assembly (Updated August 2, 2011)
A joint investigation concerning a problem with SR 100 Self-Contained Self-Rescuer.

Respirator Standards

Approved

Standards for Respirators with Chemical, Biological, Radiological, and Nuclear Protection

Standards for Respirators without Chemical, Biological, Radiological, and Nuclear Protection

Standards Under Development

  • Powered Air-Purifying Respirators
    A comprehensive standard for certifying Powered Air-Purifying Respirators (PAPRs) is under development. Information submitted to the dockets 008, 008A, and 010 will be considered in the context of development of conceptual standards for PAPRs, as well as updating equipment performance requirements to improve respirator user safety and health.

Status of Current Approval Projects

Lists of approval projects that are currently being processed, indicating the dates that processing steps were begun and completed.

Average New Approval Processing Times

Only projects that succeeded in granting approvals are included among these averages. The times shown in the table represent the average number of days the projects spent in processing. Individual projects may have resulted in the issuance of multiple approvals. Unless otherwise noted, the times listed exclude the longest 10 percent of projects in each category.

Average Number of Days for New Approvals Granted by Schedule [PDF – 103 KB]

Additional Resources and Technical Support

Additional Resources

NIOSH Pocket Guide to Chemical Hazards
A source of general industrial hygiene information on several hundred chemicals/classes for workers, employers, and occupational health professionals.

Anthropometric Data and ISO Digital Headforms
Using data collected in a 2003 survey, parameters for headforms in five size categories were developed. The 2D and 3D data is available from NIOSH.

Saving Lives: Building a Better Face Mask
Video featuring NIOSH NPPTL research to build a better face mask using facial measurements.

Certified Equipment List (CEL)
A searchable list of commercially-available, respiratory personal protective devices approved by NIOSH to meet the requirements of Title 42, Code of Federal Regulations, Part 84.

Letters to All Manufacturers and Interested Parties
Official letters announcing public meetings, new requirements, NIOSH policies, and other relevant information for our stakeholders.

Technical Support

Technical support is available by calling 412-386-4000 or by Email at npptl@cdc.gov.

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