I.S. EN ISO 11135:2014&A1:2019被替代
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)
出版：National Standards Authority of Ireland
專家解讀視頻
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.
ISO 11135 : 2014 - Identical
ISO 11135:2014 - Identical
EN ISO 11135:2014/A1:2019 - Identical
ISO 11135:2014/Amd 1:2018 - Identical
EN ISO 11135:2014/A1:2019 - Identical
