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ISO 11040-4:2015
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for fillingMore info
ISO 11040-4:2015 applies to
tubing-glass barrels (single-chamber design) for injection preparations, and
sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040-4:2015.
| Author | ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.040.25 : Syringes, needles and catheters |
| Number of pages | 52 |
| Replace | ISO 11040-4:2007 |
| Modified by | ISO 11040-4:2015/DAmd 1 |
| Weight(kg.) | 0.1884 |
| Year | 2015 |
| Country | Switzerland |