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Norm
ÖNORM EN ISO 11135
Issue date: 2020 04 01
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd 1:2018) (consolidated version)
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in b...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 107 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
This International Standard 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 International Standard does not detail a specified requirement for designating a medical device as sterile.
This International Standard does not specify a quality management system for the control of all stages of production of medical devices.
This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.
This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.
ÖNORM EN ISO 11135
2020 04 01
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
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ÖNORM EN ISO 11135
2015 03 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135
2014 10 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM CEN ISO/TS 11135-2
2011 01 15
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Norm
ÖNORM CEN ISO/TS 11135-2
2008 11 01
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Vornorm
ÖNORM CEN ISO/TS 11135-2
2008 04 01
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Vornorm Entwurf
ÖNORM EN ISO 11135-1
2007 08 01
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, valid...
Norm
ÖNORM EN 550
1994 09 01
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
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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