DIN EN ISO 25424:2022-07
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022
| Fecha edición: |
2022-07-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. |
| Keywords: | Applications|CE marking|Definitions|Developments|Formaldehyde|Health care|Hygiene|Low temperatures|Medical devices|Medical equipment|Medical products|Medical sciences|Packages|Quality management|Specification (approval)|Steam sterilization|Sterilization (hygiene)|Use|Validation|Vapours |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 25424:2019/A1:2022 Idéntica ISO 25424:2018/Amd 1:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 25424:2020-05 Reemplaza a DIN EN ISO 25424/A1:2021-03 |
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