Getting a particulate respirator approved by NIOSH requires much work and preparation. Each company that manufactures NIOSH-approved respirators has done a lot of work to develop its respirators, earn NIOSH approval, manufacture and sell these respirators, and continually maintain their quality to remain NIOSH-approved. The specific code manufacturers comply with for NIOSH approval is Code of Federal Regulations 42 part 84, commonly called 42 CFR 84.
Assuming the manufacturer has completed all the design and development work and is ready to apply for NIOSH approval, the company must prepare an extensive package for NIOSH. This includes various performance tests, drawings, packaging and label copy, detailed user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility.
For example, if a manufacturer wants to seek approval on an N95 respirator, which is designed to filter out non-oil-based particulates, it must run filter efficiency tests on the respirator using sodium chloride aerosol. The manufacturer also must perform tests on the resistance of the mask and leakage of the valve, if appropriate. In addition to these tests, the manufacturer prepares an in-depth quality control plan for its manufacturing facility, which addresses the inspection of raw materials and components ensuring they meet stated specifications, inspection and testing of the finished product, and a means of tracking where the respirators are sold. This type of preparation for NIOSH approval is not exclusive to N95 respirators. Whatever approval level the manufacturer applies for – whether it is N, R or P with an efficiency of 95 percent, 99 percent or 99.97 percent – the company must perform tests and create submittal packages that are specific for that approval.
All the data and information is assembled and submitted to NIOSH in a formal, prescribed submittal package along with samples of the respirator. NIOSH not only checks the data, but also performs its own tests to confirm the manufacturer's results. If everything passes, and the drawings and QC plans meet the standards, the manufacturer will receive a testing and certification number, which is noted on the manufacturer's product label. This process generally takes about three months from submittal to approval. If NIOSH has any simple questions, they may allow the manufacturer a reasonable amount of time to answer those questions.
Once the manufacturer receives approval, it can begin to market the respirator. Changes cannot be made to the manufacturing process that would change the performance of the respirator in any way from the way it was originally submitted to NIOSH. Each manufacturer is subject to onsite and field audits by NIOSH. During a field audit, NIOSH purchases respirators in the field and tests them in their government laboratory. If NIOSH finds any inconsistencies on-site or in the field, they can ask the manufacturer to make a correction, stop selling the product and recall existing product from the field.
All these regulations and requirements are designed to ensure the safety of the public when using these respiratory products. However, the employers and end users also must share responsibility by ensuring the respirators are used in accordance with OSHA regulations and the manufacturer's instructions, that they fit properly, and that they are not misused or abused.