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ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
standard by International Organization for Standardization, 04/01/2015
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Full Description
ISO 11040-4:2015 applies to
tubing-glass barrels (single-chamber design) for injection preparations, andsterilized 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.