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 (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Abstract
This document 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. This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This document does not detail a specified requirement for designating a medical device as sterile. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. This document does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber. This document does not cover analytical methods for determining levels of residual EO and/or its reaction products.
Begin
2020-07-29
WI
00204081
Planned document number
DIN EN ISO 11135
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
Order from DIN Media