DIN CEN ISO/TS 16775:2022-04
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021
| Fecha edición: |
2022-04-01
En Vigor
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| Idiomas disponibles: | Alemán |
| Resumen: | This Technical Specification provides guidance for the application of ISO 11607-1 and ISO 11607-2. This guidance can be used to better understand the requirements of ISO 11607 1 and/or ISO 11607 2 and to illustrate some of the many procedures and approaches available to meet the requirements of ISO 11607-1 and/or ISO 11607-2. |
| Keywords: | Applications|Biocompatibility|Biological hazards|Closures|Compatibility|Conditioning|Covers|Definitions|Density|Disposables|Germs|Hygiene|Information|Inspection|Marking|Materials specification|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Methods|Packages|Packaging material|Packaging tests|Permability|Physical testing|Products|Public health|Quality|Quality assurance|Quality management|Rating tests|Reagents|Reuse|Safety|Safety requirements|Sampling methods|Sequence of operations|Specification|Specification (approval)|Stability|Sterile barrier systems|Sterility|Sterilization (birth control)|Sterilization (hygiene)|Sterilized goods|Sterilizers|Storage|Systems|Testing|Toxicity|Transport|Use|Validation|Visual inspection (testing) |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
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Equivalencia Internacional |
Idéntica CEN ISO/TS 16775:2021 Idéntica ISO/TS 16775:2021 |
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Reemplazo Normas |
Reemplaza a DIN CEN ISO/TS 16775:2014-10;DIN SPEC 58997:2014-10 |
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