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DIN EN ISO 11608-3:2024-01
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01); German version EN ISO 11608-3:2022 / Note: To be amended by DIN EN ISO 11608-3/A1 (2025-11).
| Fecha edición: |
2024-01-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 11608 specifies the requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-based Injection Systems (NIS) which fulfil the specifications of ISO 11608-1 (and other subparts as appropriate). Containers covered in this document include single and multi-dose containers (either filled by the manufacturer or by the end-user) and fluid paths that are integrated with the NIS at the point of manufacture. |
| Keywords: | Carpules|Containers|Cylinders|Data of the manufacturer|Definitions|Design|Designations|Dimensions|Dosage|Drug administration|Injection instruments|Injection syringes|Injectors|Insulin|Liquids|Marking|Mathematical calculations|Medical devices|Medical equipment|Medical products|Medical technology|Medicine|Pen-injectors|Precision|Replaceability|Specification (approval)|Storetanks|Technical data sheets|Testing|User information |
| ICS: | 11.040.25 - Jeringuillas, agujas y catéteres |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11608-3:2022/A1:2026 Idéntica ISO 11608-3:2022 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 11608-3:2022-09 |
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