ISO-11040-4 › Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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Included in this current edition are the following subparts:
3RD EDITION - April 1, 2015
FOR 3RD EDITION AMENDMENT 1 SEE - Feb. 1, 2020
FOR 3RD EDITION AMENDMENT 1 SEE - Feb. 1, 2020
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.
To find similar documents by classification:
11.040.25 (Syringes, needles and catheters)
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Document Number
ISO 11040-4:2015
Revision Level
3RD EDITION
Status
Current
Publication Date
April 1, 2015
Committee Number
ISO/TC 76