DIN EN ISO 11135:2025-08
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025 / Note: Date of issue 2025-07-04*Intended as replacement for DIN EN ISO 11135 (2020-04).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| 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: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11135:2024-04 |
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