EN ISO 11137-1:2015/A2:2019現行
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
出版：Comite Europeen de Normalisation
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