DIN EN 556-1:2024-09
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
| Fecha edición: |
2024-09-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This European Standard specifies the requirements for a terminally sterilized medical device to be designated 'STERILE'. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441. |
| Keywords: | CE marking|Definitions|Ethylene oxide|Hygiene|Marking|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Packages|Quality assurance|Safety|Specification (approval)|Sterile|Sterile equipment|Sterility|Sterilization (hygiene)|Vapours |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 556-1:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN 556-1:2002-03 Reemplaza a DIN EN 556-1:2023-02 Reemplaza a DIN EN 556-1 Berichtigung 1:2006-12 |
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