An N95 mask is a disposable respirator that is NIOSH approved. This type of respirator is designed to filter non-oil-based particles and is 95 percent efficient at filtering these particles out. It’s a tight-fitting respirator, also referred to as a filtering face piece.
NIOSH is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. NIOSH issues recommendations for respirator use. Respirator approvals are in accordance to the NIOSH Federal Respiratory Regulations 42 CFR Part 84.
The approval holders worldwide, manufacture NIOSH approved Respirators for use in the United States and internationally. If the respirator meets NIOSH standard requirements, the manufacturer receives a testing and certification number, which appears on the product label along with the NIOSH logo.
Steps for NIOSH certification:
The two main components of a NIOSH Application are as follows
Pre-submission test data:
Masks intended for respirator precertification may require NaCl, valve leak, and inhalation/exhalation tests to verify conformity to NIOSH standards.
A total of 26 respirators of each type will be tested for the same and this data will be then submitted to NIOSH along with the application. NIOSH will then test the respirator samples against this pre-test data.
Quality Assurance Documentation:
Quality Assurance Manual and related documents as per 42 CFR 84 and catering to NIOSH standard requirements are to be submitted along with the initial application.
A Product Quality Control Plan as per NIOSH requirements is to be followed and submitted along with the initial application.
- Only an organization that designs, manufactures, assembles, or controls the assembly of a respirator may apply
to NIOSH to become an approval holder.
- All the documents and application must be submitted in English. Any files created in a language other than English will be returned unprocessed.
- NIOSH Guideline: The Standard Application Procedure for the Approval of Air-Purifying Filtering Face piece
Respirators Under 42 CFR Part 84
- Federal Regulation: Title 42 CFR Part 84
- It can take up to 6 months to get final approval from NIOSH.
- Before proceeding further with your NIOSH application, get your pre-test data ready.
- Under the new Surgical N95 guideline from NIOSH, a surgical N95 respirator is a NIOSH certified N95 respirator
which is simultaneously approved under FDA- 510(K) as a Class II medical device. This respirator can then be sold under medical claims, for use in clinical set-ups