I.S. EN ISO 11135:2014&A1:2019/LC:2019現行
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
標準編號： I.S. EN ISO 11135:2014&A1:2019/LC:2019
標準類別：Standard
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標準簡介
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.
