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ISO 11040-6

Prefilled syringes - Part 6: Plastic barrels for injectables

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Organization: ISO
Publication Date: 1 April 2012
Status: inactive
Page Count: 16
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This part of ISO 11040 specifies the materials, dimensions and requirements for plastic barrels (singlechamber design) for injection preparations, which are to be subsequently filled and assembled on standardized processing equipment.

It is applicable to pre-filled plastic syringes intended for single use only.

Pre-filled syringes can be produced on dedicated and specifically designed processing equipment. This part of ISO 11040 is not applicable to such dedicated pre-filled syringes.

Before the final approval for human use is granted, compatibility tests applying the intended pharmaceuticals are carried out. This part of ISO 11040 does not specify the procedures for such compatibility tests.

Document History

January 1, 2019
Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for...
ISO 11040-6
April 1, 2012
Prefilled syringes - Part 6: Plastic barrels for injectables
This part of ISO 11040 specifies the materials, dimensions and requirements for plastic barrels (singlechamber design) for injection preparations, which are to be subsequently filled and assembled on...

References

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