NIOSH – Respirator Certification

 

NIOSH – Respirator Certification 

 

There are three government agencies which could potentially be involved in a respirator certification, based upon the design of the respirator, the primary two are Department of Health and Human Services, Department of Labor, and the third could potentially be the EPA.

 

Department of Labor is over both MSHA and OSHA. 

These are both regulatory enforcement agencies.  MSHA oversees US mine facilities, and OSHA oversee US companies which require respirator use.The Department of Health and Human Services has both NIOSH and FDA　

 

Any medical claims, such as a surgical mask, must be reviewed and approved by the FDA; also claims against specific disease-producing airbourne pathogents.

 

Antimicrobial coatings must be cleared by either the FDA or EPA before a NIOSH approval can be granted.  Their certificate must be supplied with the application.

 

NIOSH approves respirator systems to 42 CFR 84.  This is our regulation authority.　

 

42 CFR 84.41 provides the requirements of the quality system.  

42 CFR 84 also provides the criteria for any changes to the approved respirator or the quality system which was approved.

 

It is important to understand NIOSH only approves respirator systems, not components.  Only complete respirator systems.

 

What is a NIOSH approval?  

It is a formal document issued by NIOSH.  Within that document is an assigned TC number associated with the approved respirator system.

-This approval is issued when the respirators and your quality system meets NIOSH requirements.

-The approval means you may label and advertise the respirator as NIOSH approved.

-The NIOSH approval requires that the respirator system must be labeled properly and manufactured according to the approved quality system.

 

NIOSH is recognized world-wide.  The N95 brand is also recognized world-wide.  This NIOSH approval means companies in the US which require respirator use may use it.

 

No changes to the performance or design without NIOSH approval.

-Changes to these items, including PQP, must be submitted.  Changes are sometimes necessary, but these changes above require NIOSH review.

-You may not advertise/imply that NIOSH approves a respirator against specific use; except surgical or antimicrobial related.

 

NIOSH certifies respirators.  They also evaluate the respirators and quality system after the approval is granted.  Technical assistance is also available at all times.  We can provide guidance, but we won’t tell you how to do your quality system or how to improve or make a respirator.

NIOSH disseminates information through website and via email.  STP, letter to all manufacturers, letters to all interested parties, policy statements, clarifications, manufacturer meetings (usually able to be viewed online), CEL

User Notices are also used to disseminate information.  They identity product failures or recalls.  These User Notices can also be initiated by the approval holders when an issue is noticed.  

 

If you have any questions regarding any of the other types of respirators, please feel free to contact us.