DIN Standards Committee Health Technologies
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Begin
2024-07-22
Planned document number
ISO/FDIS 11135
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible international committee
ISO/TC 198/WG 1 - Industrial ethylene oxide sterilization
draft standard
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
2025-06
Order from DIN Media
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
2026-09
Order from DIN Media
previous edition(s)
Revision of Annex E, Single batch release
2018-10
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
2014-07
Order from DIN Media
