DIN EN ISO 21649:2023-06
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023); German version EN ISO 21649:2023
| Fecha edición: |
2023-06-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a "cartridge", "ampoule", "syringe", "capsule" or "disc". In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device. |
| Keywords: | Definitions|Disposable|Disposables|Drug administration|Equipment for single use|Injection instruments|Injections|Injectors|Inspection|Instructions for use|Marking|Measuring uncertainty|Medical devices|Medical equipment|Medical products|Medical sciences|Reuse|Specification (approval)|Testing|Testing conditions |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 21649:2023 Idéntica ISO 21649:2023 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 21649:2010-01 Reemplaza a DIN EN ISO 21649:2022-03 |










