1.1 This specification establishes requirements for medical face masks used as (1) a means of source control from individual wearers by reducing expelled aerosols or droplets from the wearer’s nose and mouth into the air; and (2) to help protect portions of the wearer’s face covered by the medical face masks from splashes, sprays, and spurts of blood or other potentially infectious materials, when used in providing health care services such as surgical procedures and other patient care activities where fluid exposures are anticipated (e.g., blood draws, managing body fluids).

1.2 This specification only addresses single-use, disposable medical face masks.

1.3 This specification establishes minimum design, performance, labeling, user instructions, classification, and conformity assessment requirements for medical face masks.

1.4 While this specification and Specification F3502 on barrier face coverings have common requirements, it should not be inferred that meeting this specification for medical face masks means that Specification F3502 is met or that barrier face coverings that meet Specification F3502 meet this specification for medical face masks.

1.5 This specification does not address pediatric face masks or medical face masks used by children.

1.6 This specification does not address requirements for regulated respiratory protective devices such as respirators, which may be necessary for some health care services for addressing exposure to inhalation hazards.

1.7 This specification does not address antimicrobial claims for medical face masks.

1.8 The values stated in SI units are to be regarded as standard.

1.9 The following precautionary caveat pertains only to the test methods portion, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.