1.1.This specification establishes minimum design, performance, labeling, and care requirements for reusable, barrier masks for use by the general public and workers. 1.2.This specification is intended to apply to the general public and workers mask to serve as source control to reduce the number of expelled particles from the wearer into the air and have a degree of fit and particulate filtration capability to minimize the inhalation of particulate matter. 1.3.For the purposes of this specification, workers are those outside a healthcare setting and are not required by regulatory agencies such as the Occupational Safety and Health Administration to wear respiratory protection to prevent the inhalation of hazardous substances. 1.4.This specification provides requirements for barrier masks. 1.4.1.This specification includes design and general construction criteria. 1.4.2.This specification includes criteria for head suspensions. 1.4.3.This specification establishes bacterial and solid particulate filter efficiency criteria. 1.4.4.This specification includes criteria for inhalation and exhalation breathing resistances. 1.4.5.This specification includes sizing and fit testing criteria. 1.4.6.This specification establishes requirements for user instructions including donning and doffing, sizing, cleaning, and recommended period of use. 1.4.7.This specification may establish other requirements, for example splash resistance, rigidity, etc. 1.4.8.This specification establishes specific packaging and labeling requirements for barrier masks meeting the requirements of this specification. 1.5.Nothing in this specification is intended to contradict or replace criteria that are established in 42 CFR for air-purifying respirators or requirements for use of respirators in accordance with 29 CFR 1910.134. 1.6.Nothing in this specification is intended to infer that barrier masks are respiratory protection or can be used in a healthcare setting. 1.7.Nothing in this specification is intended to infer that barrier masks should be placed on young children under age 2 or anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance.
Keywordsbarrier mask; source control; infectious aerosol
This specification describes a product that could be used as a source control for reducing the risk of the transmission of an infectious disease, and for reducing the risk of inhalation of particulate matter to protect the wearer. It is not intended for use in a health care setting. It is intended to be used in conjunction with public health recommendations regarding protective measures for the general public. The United States needs an actual standard specification not a guidance document or monograph such as what has been prepared by the AATCC (American Association of Textile Colorists and Chemists Monograph, AATCC MXXX 2020 Guidance and Considerations for General Purpose Textile Face Coverings: Adult (AATCC, 2020)). Europe has proposed a standard that is also a guide, though more comprehensive than AATCC because it addresses both child and adult sizing. Because personal protective equipment (PPE) plays an important role in keeping many workers within various industries safe while performing their professional duties, The National Personal Protective Technology Laboratory (NPPTL) was created to be the division of NIOSH charged with the mission of preventing disease, injury, and death for the millions of working men and women relying this equipment. To accomplish this mission, NPPTL conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard. The NPPTL is approaching Subcommittee F23.65 for the purpose of creating a specific barrier mask standard that adapts current standards and proposals to encourage the use of commercially manufactured barrier masks in the workplace, and commercially manufactured and homemade barrier masks by the general public, by having national standards that specify design and performance characteristics. The development of a comprehensive U.S. standard provides a level playing field for demonstration of product claims and avoid the general confusion related to barrier mask effectiveness with the contemplated need is for the COVID-19 pandemic and other infectious particulate exposure event applications. The mask described in this ASTM standard primarily forms a barrier to reduce the number of expelled particles from the wearer into the air and has an acceptable level of breathing resistance, but additionally has a degree of fit and particulate filtration capability to minimize the inhalation of particulate matter. The proposed standard sets two different levels of filtration efficiency based on a generalized (nonstandard) test method and sets requirements for breathing resistance in error ability based on existing European Norms, which are easily accessible. The standard would bring value to general population and industry by specifying minimum design, performance and testing requirements and allow comparison of products by end users where currently guidelines have been limited. It is NPPTLs opinion that federal rulemaking is not a viable option. Similarly, the development of this standard under other standard development organizations does not offer an expedient approach. ASTM International and its newly formed F23.65 Subcommittee on Respiratory [Hazards] is perceived to be an efficient, open and transparent, and balanced organization for the development of this standard. The NPPTL intends to encourage the participation of all interested parties in F23.65 in the development of this standard.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as F3502-2021 and Pending Publication