ASTM F2100-26
Standard Specification for Medical Face Masks
| Označení normy: | ASTM F2100-26 |
| Vydáno: | 15.02.2026 |
| Status: | Active |
| Počet stran: | 7 |
| Sekce: | 11.03 |
| Označení: | bacterial filtration efficiency; dental masks; differential pressure; fluid resistance; general use; isolation masks; medical face masks; patient care masks; procedure masks; source control; sub-micron particulate filtration; surgical masks; |
| ASTM označení: | ASTM F2100 |
| Nahrazuje: | F2100-25 |
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.
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.
Note 1: “Single-use” is not defined in this standard but is intended to indicate that the product would not be subject to cleaning, decontamination, disinfection, reprocessing, or sterilization by steam or low-temperature sterilization modalities and instead would be disposed of following its first use. The specific period of use, whether for each individual occasion of use, multiple uses over a finite period of time, wearing until soiled, or some other practice, is left up to the organization specifying the use of this product in collaboration with medical face mask manufacturers and facility policy.
1.3 This specification establishes minimum design, performance, labeling, user instructions, classification, and conformity assessment requirements for medical face masks.
1.3.1 Design requirements include setting the minimum areas of coverage for the medical face mask over the wearer’s nose and mouth, the quality of materials and components, the use of a retention system (e.g., ties or ear loops) for securing the medical face mask on the individual wearer’s face, permissibility for multiple sizes, and the integration of optional face shields as part of the medical face masks.
1.3.2 This specification provides for the classification of medical face mask performance. Classification of medical face mask performance is based on testing for bacterial filtration efficiency, differential pressure (a measure indicating the resistance of an individual breathing through the medical face mask), sub-micron particulate filtration efficiency, and resistance to penetration by synthetic blood. Additional performance requirements are provided for flame spread (flammability) and biocompatibility of medical face masks.
1.3.3 This specification does not address the fit of a medical face mask on an individual wearer’s face in terms of inward or outward leakage around the periphery of the mask during inhalation or exhalation.
1.3.4 Labeling requirements specify the content for labels that appear on the packaging in which the medical face masks are provided.
1.3.5 User instructions are required to guide selection among the different classifications, inform and warn about product limitations, and describe when masks should be replaced and how to properly dispose of masks.
1.3.6 Conformity assessment is demonstrated with a Supplier Declaration of Conformity (SDOC) following the recommendations in Guide F3050, Annex A3, Model B. The SDOC states that medical face masks labeled as compliant meet all of the requirements of this specification, including design, performance, testing, labeling, and user information.
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.
Note 2: In the United States, performance requirements for respirators are described in 42 CFR Part 84 of U.S. regulations and NIOSH must approve such respirators.
1.7 This specification does not address antimicrobial claims for medical face masks.
Note 3: The use of antimicrobial materials, finishes, or mechanisms is generally subject to regulatory oversight by government agencies, including the U.S. Environmental Protection Agency and U.S. Food and Drug Administration in the United States, which apply additional safety and efficacy requirements to these products. See 5.2 for the requirement of nontoxic and non-irritating materials used in the construction of 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.