1.1 This specification established requirements for design, performance, testing, and label of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.2 This specification references Specification F2100 that address the testing and classification of medical face mask materials for different areas of performance that include bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 1.3 This specification includes additional requirements not covered in Specification F2100 such as biocompatibility requirements for face contact materials, areas of face coverage, the type and strength of ties or elastic loops used to secure the mask on the individual wearer, the provision of partial face shields when attached to the medical face mask, full product testing, product labeling, and minimum conformity assessment requirements. 1.4 This specification does not address all aspects of medical face mask design and performance. This specification does not apply to regulated respiratory protection, which may be necessary for some healthcare services.
bacterial filtration efficiency; differential pressure; fluid resistance; general use; medical face masks; surgical masks; procedure masks; particle filtration efficiency; sub-micron filtration
Specification F2100 only addresses materials used in the construction of medical face masks. There are several other properties and aspects for medical face mask that need to be addressed for providing consistency for the quality of medical face masks that are used primarily by healthcare workers, both for source control and minimal levels of protection. Since Specification F2100 is a mature standard that is already being revised, a larger process for addressing full product design, performance, labeling, and conformity assessment is being undertaken in this proposed standard.
The title and scope are in draft form and are under development within this