DIN EN ISO 13408-6:2021-11
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021
| Fecha edición: |
2021-11-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 13408 specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell based health care products. This International standard does not specify requirements for restricted access barrier systems (RABS). This part of ISO 13408 does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and / or compendia requirements that pertain in particular to national or regional jurisdictions. |
| Keywords: | Aseptic|CE marking|Checks|Cleaning|Decontaminations|Definitions|Health services|Insulators|Isolators|Medical devices|Medical sciences|Medical technology|Operation|Production|Public health protection|Quality assurance|Selection|Specification|Specification (approval)|Sterility|Training|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 13408-6:2021 Idéntica ISO 13408-6:2021 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 13408-6:2013-07 Reemplaza a DIN EN ISO 13408-6:2019-05 |
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