DIN EN ISO 11135:2020-04
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); German version EN ISO 11135:2014 + A1:2019 / Note: To be replaced by DIN EN ISO 11135 (2023-05), DIN EN ISO 11135 (2024-04).
| Edition date: |
2020-04-01
In Force
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|---|---|
| Available languages: | English, German |
| 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. |
| Keywords: | Acceptance (approval)|Acceptance specification|Checks|Commissioning|Definitions|Ethylene oxide|Evaluations|Examination (quality assurance)|Germicides|Hygiene|Inspection|Instructions|Maintenance|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Microbiological analysis|Operation|Operators (personnel)|Personnel|Public health|Public health protection|Qualifications|Quality management|Routine tests|Safety|Safety engineering|Safety requirements|Specification (approval)|Sterilization (birth control)|Sterilization (hygiene)|Sterilizers|Storage|Surveillance (approval)|Testing|Validation |
| ICS: | 11.080.20-Disinfectants and antiseptics |
| CTN: | |
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International Equivalence |
Identic EN ISO 11135:2014/A1:2019 Identic ISO 11135:2014/Amd 1:2018 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11135:2014-10 Reemplaza a DIN EN ISO 11135/A1:2017-09 |










