Pfriem, Dale

ICS Laboratories
1072 Industrial Parkway ‑ North
Brunswick, Ohio 44256
USA

The paper presents a model for NIOSH respiratory protective device approval (certification) utilizing accredited independent testing laboratories for the evaluation of the various functional and performance attributes of such devices.  The Independent Laboratory test results (and test report thereof as submitted to NIOSH form the basis of the respiratory protective devices performance conformity to the standards and regulations as set forth by NIOSH.

Applicants seeking NIOSH approval of respiratory protective devices (RPD) submit samples of the RPD to the accredited laboratory of their choice.  Upon receipt of the test report from the laboratory, the applicant forwards their application, inclusive of applicable drawings and documentation to NIOSH, as per their designated role within the United States as approval body (certified) of respiratory protective devices.  The approval process as pertain to NIOSH is now administrative in the formal review of the technical file consisting of drawings, documents, QA protocols and the test report itself.

Laboratories desiring recognition of their test reports by NIOSH, apply to the agency for accreditation.  The agency, pending the positive review and audit of the applying laboratories capabilities, competence and quality assurance practices, then accredits the laboratory pursuant to the limitations of scope. Laboratories are subject to annual audit and review by NIOSH in order to maintain accreditation status.