Superseded
Draft standard
Historical
DIN EN ISO 11135:2012-09
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012
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Summary
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.
Notes
Prévu pour remplacer DIN EN ISO 11135-1 (2007-08), DIN ISO/TS 11135-2 (2010-01).
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 09/01/2012 |
| Cancellation Date | 10/01/2014 |
| Page Count | 99 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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01/04/2020
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