European Standards for Respiratory protective device

US Government Agencies Involved in Respiratory Protection Regulations

The Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration (MSHA) require use of NIOSH approved respirators 

Any Surgical mask claims must be cleared by the U. S. Food and Drug Administration (FDA) Before a NIOSH Approval can be granted.

Claims for protection against specific disease-producing airborne pathogens are medical claims and place a device under the jurisdiction of FDA.

NIOSH authority to approve respirators found in 42 CFR 84  

Requires: 

* Label the respirator as specified in the approval     

* Production must be under the quality control provisions specified in the approval   

NIOSH does not permit changes to approvals without notifying NIOSH for a modification of approval.

US Testing Overview: Filtering Facepieces

Standard Testing On Filtering Facepieces

There are four standard tests for filtering facepieces :

* Exhalation Resistance   

* Inhalation Resistance 

* Filter Efficiency – Sodium Chloride (NaCl) or (Dioctyl Phthalate)     

* Exhalation Valve Leakage  

our advantages:

HUIIMO has long supported clients in the field of personal protective equipment (PPE) by offering testing and certification on a huge variety of products.

In Europe, it is a legal requirement to have compliance assessment before placing the product on the market. This is achieved through a type-examination process which includes independent product testing and conformity checks on production. Both the type-examination and ongoing conformity checks must be carried out by an official conformity assessment body, such as OTEI, DGUV, INSPEC, BSI.

For more information, please contact us!