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ASTM Mask Protection Standards Medical Supplies

ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100 11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria1.

PMDA Japan and Medical Device RegulationTÜV SÜD

Japans medical device classification system is based on Japanese Medical Device Nomenclature codes, which differ somewhat from the classification schemes used in the U.S. or the European Union. As of April 2005, third party registered certification bodies (RCBs) are permitted to evaluate Class II devices and conduct marketing certification

The Basics of Surgical Mask Selection Infection Control

A surgical mask is an example of an article regulated as a medical device. NIOSH. The National Institute for Occupational Safety and Health (NIOSH) is a federal agency and branch of the Department of Health and Human Services whose function is to identify substances that pose potential health problems and recommends exposure limits to OSHA.