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ISO 11040-6

Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

active, Most Current
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Organization: ISO
Publication Date: 1 January 2019
Status: active
Page Count: 60
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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 single use only.

This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.

Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

Document History

ISO 11040-6
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...
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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