DIN ISO 11040-6:2021-05
Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019)
| Fecha edición: |
2021-05-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes. |
| Keywords: | Anaesthesiology|Biological characteristics|Chemical properties|Containers|Definitions|Design|Dimensions|Disposable|Equipment for single use|Injection instruments|Injection syringes|Injections|Marking|Materials|Medical instruments|Medical sciences|Medical technology|Packages|Parenteral infusion equipment|Physical properties|Plastic containers|Plastics|Single use syringes|Syringe bodies|Syringes |
| ICS: | 11.040.25 - Jeringuillas, agujas y catéteres |
| CTN: | |
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Equivalencia Internacional |
Idéntica ISO 11040-6:2019 |
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Reemplazo Normas |
Reemplaza a DIN ISO 11040-6:2020-10 |
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