I.S. EN ISO 11135:2014&A1:2019/LC:2019现行
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
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基本信息
标准编号： I.S. EN ISO 11135:2014&A1:2019/LC:2019
标准类别：Standard
出版单位：
标准页数：0
标准简介
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
