1.1 This specification establishes design, performance, documentation, and labeling requirements and provides test methods for protective clothing used in preventing exposure of healthcare workers and patients to liquid chemotherapy and other hazardous drugs in healthcare and related applications. 1.1.1 The principal requirement of this specification is permeation resistance testing of the protective clothing barrier material and seams to a minimum of nine chemotherapy drugs. The protective clothing barrier material and seams are required to demonstrate breakthrough detection times of 30 min or more for at least five of the chemotherapy drugs. 1.1.2 Permeation resistance test results are also reported for additional chemotherapy and other hazardous drugs. 1.1.3 Protective clothing meeting this specification is also required to meet minimum flammability requirements, biocompatibility if used for breached skin contact, and demonstrate sterility assurance, if sterilized prior to use. 1.1.4 Physical properties that indicate the strength, durability, and breathability of the protective clothing are reported. 1.1.5 Additional requirements are established for the label and user information to be provided for protective clothing meeting this specification. 1.1.6 This specification does not address requirements for protective clothing that is intended to be reused. 1.2 This specification does not address all conditions of exposure for individuals who wear protective clothing in the compounding, preparation, and administration of liquid chemotherapy and other hazardous drugs in addition to patient care activities and spills where contaminated items with these drugs are encountered. 1.3 This specification does not address chemotherapy drugs or hazardous drugs that may be encountered in the form or a vapor or aerosol and does not provide any criteria for respiratory protection. 1.4 This specification does not address the selection, use, or care of protective clothing used for protection against chemotherapy or other hazardous drugs. See USP 800, Hazardous DrugsHandling In Healthcare Settings, for specific guidelines on the selection, use, and care of personal protective equipment for protection of healthcare workers against chemotherapy or other hazardous drugs. 1.5 Units--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. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.
protective clothing; chemotherapy; antineoplastic drug; coverall; gown; apron; sleeve protector; sleeved apron; smock; barrier performance; permeation resistance; breakthrough detection time; physical properties
There is currently no standard to address the performance of garments used by those in the healthcare profession who mix and apply chemotherapy drugs. These drugs are highly toxic and can cause severe health issues if accidentally contact. FDA representatives have commented on the need for this type of standard to address isolation gowns and other protective clothing worn by those involved with the administration of chemotherapy drugs.
The title and scope are in draft form and are under development within this