1. Scope

1.1 This specification establishes minimum design, performance, labeling, certification, and care requirements for reusable, elastomeric half-mask air-purifying respirators (APRs) for use by first responders in all-hazards applications. 1.2 This specification is intended to apply to first responders that encounter hazards that include, but are not limited to chemical and related hazards below immediately dangerous to life and health (IDLH) concentrations, particulate hazards, and bioaerosols. 1.3 For the purposes of this specification, first responders include fire fighters, law enforcement personnel, emergency medical service personnel, and other individuals that operate outside a healthcare setting. 1.4 This specification provides requirements is in addition to already established U. S. Federal regulations for APRs within Subpart I of 42 CFR Part 84. 1.4.1 This specification includes additional design criteria in the form of a requirement for a speaking diaphragm and a standardized inlet attachment for particulate cartridges. 1.4.2 This specification includes additional performance criteria for 1.4.3 This specification establishes specific labeling requirements for respirators meeting the requirements of this specification in addition to marking requirements established in 42 CFR Part 84. 1.4.4 This specification requires third party certification of APRs to this specification in accordance with conformity assessment Model D specified in Guide F3050. 1.4.5 This specification sets requirements for demonstration of effective cleaning and disinfection for instructions provided by the manufacturer with compliant APRs.

Keywords

air-purifying respirator; half-mask; elastomeric; first responder; all hazards

Rationale

This working document is being provided at the request for the Interagency Group (IAB) PPE Subgroup. The IAB, originally formed in October of 1998, is a voluntary collaborative panel of emergency preparedness and response practitioners from a wide array of professional disciplines from Federal, state, and local departments. Its mission is to strengthen the nations ability to prepare for and respond safely and effectively to emergencies, disasters, and CBRNE incidents. The IAB purposely comprises a very diverse body of emergency preparedness and response experts but is unified by a common set of criteria: emphasizing interoperability, compatibility, and standardization; fostering a multidisciplinary perspective; facilitating effective intergovernmental partnerships; being a credible voice of the responder community; being proactive; and, sharing field operational experiences and practices. The IAB membership comprises approximately 200 dedicated professionals with 77% having a first responder background representing career, combination, and volunteer departments. The IAB PPE Subgroup is approaching Subcommittee F23.65 for the purpose of creating a specific respirator standard that builds on current NIOSH criteria in 42 CFR Part 84 but provides additional requirements needed by first responders to improve the sustainable supply of respirators for all hazards emergencies, though the principal contemplated need is for the COVID-19 pandemic and related particulate exposure event applications. The IAB PPE Subgroup has considered other SDOs for the purpose of developing this standard. It is IAB Subgroups opinion that federal rulemaking, the normal pathway for standards on respiratory protection devices, is not a viable option. Similarly, the development of this standard under the National Fire Protection Association (NFPA) 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 IAB Subgroup 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.