Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Abstract
ISO 11135:2014 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.
Begin
2020-07-29
WI
00204094
Planned document number
DIN EN ISO 11135 rev
Project number
06302046
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204 - Sterilization 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 (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
2023-05
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Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
2024-04
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