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ISO 11040-4:2015

Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

General information

Withdrawn from 03.06.2024
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.06.2024
Main
28.02.2020
Amendment
02.04.2015
Main
Main
ISO 11040-4:2007
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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