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Standard [CURRENT]

DIN ISO 11040-4:2017-07

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

German title
Vorgefüllte Spritzen - Teil 4: Spritzenzylinder aus Glas für Injektionspräparate und sterilisierte und vormontierte Spritzen zur Abfüllung (ISO 11040-4:2015)
Publication date
2017-07
Original language
German
Pages
68

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Publication date
2017-07
Original language
German
Pages
68
DOI
https://dx.doi.org/10.31030/2657206

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Overview

This part of ISO 11040 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. This part of ISO 11040 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 this part of ISO 11040 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040. Based on the diameter of the prefilled syringes, appropriate components, such as rubber plungers, tip caps, needle shields, and other closure systems can also be standardized. In conjunction with the right sealing components, they offer a system for (parenteral) injectable use. The producers of filling machines can apply this part of ISO 11040 to achieve a degree of standardization in the equipment of the machines.

Content
ICS
11.040.25
DOI
https://dx.doi.org/10.31030/2657206
Replacement amendments

This document replaces DIN ISO 11040-4:2007-10 .

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