DIN EN ISO 11607-1:2024-02
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023
| Fecha edición: |
2024-02-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 11607 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. This Amendment 1 expands on the application of risk management throughout the phases of design and development, validation and production of the packaging system. The 2020 version will be extended to include, among other things, Annex F "Risk management" and Annex G "Risk management for medical device packaging rationale for requirements". |
| Keywords: | Applications|Aseptic|Biocompatibility|Biological hazards|CE marking|Closures|Compatibility|Conditioning|Covers|Definitions|Density|Design|Disposables|Forming|Germs|Hygiene|Information|Inspection|Marking|Materials specification|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Methods|Packages|Packaging material|Packaging tests|Performance|Permability|Physical testing|Products|Public health|Qualifications|Quality|Quality assurance|Quality management|Rating tests|Reagents|Reuse|Safety|Safety requirements|Sampling methods|Sealing|Sequence of operations|Shaping|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 EN ISO 11607-1:2020/A1:2023 Idéntica ISO 11607-1:2019/Amd 1:2023 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11607-1:2020-05 Reemplaza a DIN EN ISO 11607-1/A1:2022-08 Reemplaza a DIN EN ISO 11607-1/A11:2022-08 |
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