ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
| Edition date: |
2014-07-07
In Force
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|---|---|
| Available languages: | English, French |
| Summary: | 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. L'ISO 11135:2014 spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine du procédé de stérilisation des dispositifs médicaux à l'oxyde d'éthylène dans l'industrie et dans les établissements de santé, et reconnaît les similitudes et différences entre les deux applications. |
| ICS: | 11.080.01-Sterilization and disinfection in general |
| CTN: | ISO/TC 198 - 54576 |
|
Standards Cancellations |
Anula a ISO 11135-1:2007 Anula a ISO/TS 11135-2:2008 Anula a ISO/TS 11135-2:2008/Cor 1:2009 Es anulada por ISO/DIS 11135 Es anulada por ISO/DIS 11135 |
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International Equivalence |
Identic UNE-EN ISO 11135:2015 |
|
Modificaciones Normas |
Es modificada por ISO 11135:2014/Amd 1:2018 |
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Normas Conjuntas |
Trabajo conjunto ISO/IEC 13818-1:2000/Cor 2:2002 |










