Significance and Use
4.1 As with other hazardous materials protective ensembles, air-fed protective ensembles include clothing and equipment items needed for dermal and respiratory protection, including protective suits, gloves, footwear, and eye/face protection. Unlike other protective ensembles, air-fed protective ensembles do not use separate respiratory protective devices such as self-contained breathing apparatus (SCBA) or non-powered air-purifying respirators (APRs).
4.1.1 Those types of respirators normally have a tight-fitting face piece that provides inhalation hazard protection and dermal exposure protection to the face, eyes, nose, and mouth.
4.1.2 Air-fed protective ensembles are worn without the use of a separate respirator. The entire suit serves as the respiratory protective device and also provides dermal exposure protection. The wearer breathes supplied air or filtered air pumped into the protective suit.
4.2 Air-fed protective ensembles are used to protect workers in a number of applications.
4.2.1 These include, but are not limited to: chemical and pharmaceutical manufacturing, remediation of hazardous materials sites, use against highly infectious biological agents in Biosafety Level 4 laboratories, and for protection of workers involved in nuclear and radiological facilities, where it is possible radioactive particles will be encountered.
4.3 The requirements of this specification have been partly based on the NFPA 1991 and NFPA 1994 standards, which establish criteria for vapor-protective ensembles used in hazardous materials emergencies. NFPA 1991 establishes requirements for a protective ensemble that encapsulates the wearer and the breathing apparatus. NFPA 1994 establishes requirements for a protective ensemble under Class 1 requirements that in some configurations encapsulates the wearer and the breathing apparatus.
4.3.1 In this specification, a breathing apparatus is not worn inside the suit, but instead breathing air is connected to the suit either via an external air line or respiratory protective equipment that is externally connected to the suit wall. Extensive criteria for the integrity of the overall ensemble are applied through design and performance requirements. This allows for different configurations of a protective ensemble that incorporates a hooded visor, protective gloves, protective footwear, and the respiratory protective equipment.
4.4 The qualification of the respiratory protective equipment is addressed by the applicable requirements for respirators established in 42 CFR Part 84. As such, the entire air-fed ensemble is subject to certification by NIOSH in addition to meeting the requirements in this specification.
4.5 This specification establishes classifications for the protective ensemble. The classifications include one that is determined by the configuration of the protective ensemble and one that concerns the use of the protective ensemble.
4.5.1 A protective ensemble can be classified as an “air line protective ensemble” or a “PAPR-based air-fed protective ensemble.” Under each of these classifications, protective ensembles can be further classified as “limited use” and “multiple use.”
4.5.2 These classifications account for differences in the configuration of the air supply and material strength and durability. These classifications do not account for the decontamination effectiveness of multiple-use ensembles.
4.6 In recognition of the potential diverse applications to which the protective ensemble can be used, documentation requirements are provided for manufacturers to base claims for permeation resistance of ensemble materials against specific chemicals or for claims of ensemble material performance against blood-borne (or liquid-borne) pathogens. Similar requirements are established for the respiratory protective equipment, when this equipment is based on the use of filters, cartridges, or canisters.
4.7 The requirements in the certification section are based on the recommendations provided for conformity assessment example category B in Annex A2 of Guide F3050. This category specifies that the supplier provides a declaration of conformity with testing conducted at an independent laboratory that is accredited to ISO 17025 and manufacturer quality management system that is registered to ISO 9001 with the appropriate scope for air-fed ensembles, and with manufacturer/supplier periodic monitoring of continuing conformity. The manufacturer is permitted to exceed these requirements.
Scope
1.1 This specification establishes design, performance, classification, documentation, labeling, and certification requirements for protective ensembles that deliver air to the wearer by means of an air line or powered air purifying respirator (PAPR).
1.2 As a prerequisite to this specification, regulations within Title 42 Federal Code of Regulations, Part 84 are used to establish the conformance of the air-fed protective ensemble to respiratory protection requirements.
1.3 This specification addresses protective ensembles used for environments involving chemical, biological, and radiological/nuclear particulate hazards.
1.4 This specification sets specific criteria for air-fed protective ensembles used to prevent exposure to substances such as, but not limited to, chemical hazards, infectious microorganisms requiring Biosafety Level 4 (BLS4) protection, and environments where it is possible radiological or nuclear particulates will be found.
1.5 This specification is further used for classification of the protective ensemble as limited use or multiple use.
1.6 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.7 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.
1.8 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.
