EN ISO 11135:2014/A1:2019
修订附件E 单批次释放 包含修改件A1,2019
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)