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  • BSI
    BS ISO 11040-4:2015+A1:2020 Prefilled syringes - Glass barrels for injectables and sterilized subassembled syringes ready for filling
    Edition: 2020
    $497.46
    / user per year

Description of BS ISO 11040-4:2015+A1:2020 2020

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.

NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Where relevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this part of ISO 11040.



Standard NumberBS ISO 11040-4:2015+A1:2020
TitlePrefilled syringes - Glass barrels for injectables and sterilized subassembled syringes ready for filling
StatusRevision Underway
Publication Date2020-03-09
ReplacesBS ISO 11040-4:2007, BS ISO 11040-4:2015
Identical National Standard OfISO 11040-4:2015/Amd.1:2020
AmendsBS ISO 11040-4:2015
DescriptorsMedical equipment, Injection instruments, Glass, Performance, Syringes, Containers, Glass tubes, Medical instruments, Disposable, Dimensions
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/212
ISBN978 0 539 02484 5
PublisherBSI
Pages60

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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