ISO 11040-4:2015 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

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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.
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Status: Active ChangeNumber: 3 InternationalClassificationCodeOfStandards: 11.040.25 TechnicalCommittee: ISO/TC 76 ActivatedDate: 25.11.2020 PagesCount: 52 Language: en

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