This document specifies the requirements, marking and instructions for use as well as packaging, transport and storage of disposable protective clothing for medical use, and test methods are described accordingly.
This document is applicable to the disposable protective clothing for medical use (hereinafter referred to as “protective clothing”) worn by medical personnel during the medical work, disease prevention and control, etc., when there are potential risks of exposure to infectious blood, body fluids, secretions, airborne particles, etc.
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本文件提供了在环氧乙烷灭菌过程后采用参数放行的方法进行产品灭菌放行的指南,以符合GB 18279-2023的要求。
本文件适用于为现有灭菌过程采用参数放行提供方法,也适用于为新的灭菌过程而开发并实施参数放行规范。本文件强调了影响环氧乙烷灭菌过程重现性的其他过程因素的重要性和相互关系,例如装载方式和设备性能。注: 为便于使用,本文件中的条款编号与GB 18279-2023的条款编号相对应,与GB 18279-2023一致的条款,用“未规定或给出附加指南”描述,不一致的条款,增加或修改相应内容。本文件不适用于生物指示物放行。对于已确认灭菌周期的合格声明包含生物指示物无微生物生长的要求,本文件没有提供附加的指南。
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