DIN EN ISO 11608-4:2022-09
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022); German version EN ISO 11608-4:2022
| Fecha edición: |
2022-09-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software). The electronic needle based injection system (NIS-E) can be single use, reusable, and/or rechargeable. It is intended to deliver medication to an end-user by self-administration or with assistance. |
| Keywords: | Cannulas|Computer software|Containers|Data of the manufacturer|Definitions|Design|Designations|Dimensions|Dosage|Drug administration|Electronic engineering|Electronic equipment and components|EMC|Hand-held|Injection instruments|Injection syringes|Injectors|Marking|Mathematical calculations|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Needles|Pen-injectors|Precision|Replaceability|Software|Specification (approval)|Technical data sheets|Testing|User information |
| ICS: | 11.040.25 - Jeringuillas, agujas y catéteres |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11608-4:2022 Idéntica ISO 11608-4:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11608-4:2007-11 Reemplaza a DIN EN ISO 11608-4:2020-05 |
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