The ASTM F2100-21 standard defines the performance requirements for medical face masks in the US, ensuring their quality and safety. It covers key tests such as fluid resistance, bacterial filtration efficiency (BFE), and particle filtration efficiency (PFE).
Medical face masks are considered as medical devices and regulated by national medical device regulations. Regulations will define the legal obligations, to ensure that medical face masks provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standards.