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. Author manuscript; available in PMC: 2020 May 30.
Published in final edited form as: J Int Soc Respir Prot. 2018;35(1):35–46.

Table I.

Summary of NIOSH Approval Program Requirements

The U.S. respirator approval program activities are comprehensive including:

  • Evaluation of respirator design documents (engineering drawings, respirator specifications, performance test results)

  • Evaluation of the applicant’s manufacturing quality assurance system

  • Evaluation of the applicant’s respirator quality control plans

  • Evaluation of applicant user instructions, packaging and component labels

  • Inspection of the respirator and its components to confirm design specifications

  • Testing to confirm performance conforms to Federal regulations and where applicable national standards

  • Additional tests, cautions, and limitations of use as deemed appropriate to assess adequacy of protection for the intended use of the respirator

  • On-going post-approval audit of manufacturing sites

  • On-going post-market inspection and testing of approved respirators

  • Issuance of public user notices

  • Issuance of notices to manufacturers concerning policy or regarding stop sale, recall, or retrofit to approved products where investigations have identified non-conformance

  • Revocation of the Certificate of Approval for cause