NIOSH Respirator Certificate of Approval, Approval Labels, and User Instructions
Letter to All Respirator Manufacturers
May 15, 2015
Subject: NIOSH Respirator Certificate of Approval, Approval Labels, and User Instructions
The National Institute for Occupational Safety and Health (NIOSH) issues certificates of approval for respiratory protection equipment under the provisions of Title 42, Code of Federal Regulations, Part 84 (42 CFR 84). NIOSH will issue certificates of approval only for complete respirator assemblies or combination respirator assemblies that meet the minimum requirements set forth in the regulation. The issuance of the NIOSH certificate licenses the approval holder to use the NIOSH approval label and obligates them to maintain the quality of the product and provide replacement parts in accordance with the approval.
NIOSH approval-holders communicate NIOSH-approved configurations to the user community and other affected parties through the NIOSH Approval Labels and related User Instructions. The labels and User Instructions serve as notification that the products listed are NIOSH approved and document approved configurations, protections, and any pertinent cautions and limitations with regard to use.
The NIOSH Approval Labels list the major subassemblies that belong to the approved respirator configurations. If any major subassembly has user-replaceable components which are not listed on the approval labels, they must be identified (by part number) in the User Instructions. The User Instruction manuals are controlled documents that are maintained as part of the approval and listed on the approval label for most types of NIOSH-approved respirator assemblies.
Chief, Technology Evaluation Branch
National Personal Protective Technology Laboratory