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DIN ISO 11040-4:2017-07

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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)

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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.

Author DIN
Editor DIN
Document type Standard
Format File
ICS 11.040.25 : Syringes, needles and catheters
Number of pages 68
Replace DIN ISO 11040-4 (2007-10)
Cross references ISO 11040-4 (2015-04), IDT
Set MYSTD-20STD
Year 2017
Document history DIN ISO 11040-4 (2017-07)
Country Germany
Keyword DIN ISO 11040;11040