DIN EN ISO 13408-2:2018-06
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018 / Note: To be amended by DIN EN ISO 13408-2/A1 (2025-11).
| Fecha edición: |
2018-06-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. |
| Keywords: | Aseptic|CE marking|Clean rooms|Containers|Definitions|Filter system|Filters|Filtration|Fluids|Guide books|Health services|Insulators|Maintenance|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Occupational medicine|Personnel|Processing|Public health protection|Quality assurance|Quality management|Specification (approval)|Sterile|Sterility|Sterilization (hygiene)|Surveillance (approval)|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 13408-2:2018/prA1:2025 Idéntica ISO 13408-2:2018 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 13408-2:2011-09 Reemplaza a DIN EN ISO 13408-2:2017-04 |
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