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现行 ISO 20857:2010
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Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices 保健品灭菌——干热;医疗器械灭菌过程的开发、验证和常规控制要求
发布日期: 2010-08-17
ISO 20857:2010规定了医疗器械干热灭菌过程的开发、验证和常规控制要求。 尽管ISO 20857:2010主要针对干热灭菌,但它也规定了与使用干热的脱热原过程相关的要求并提供了指南。
ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.
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归口单位: ISO/TC 198
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