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BS ISO 11040-4:2015+A1:2020

BS ISO 11040-4:2015+A1:2020

Current

Current

The latest, up-to-date edition.

Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-09-2020

Publisher

British Standards Institution

The British Standards InstitutionThis part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes readyThe British Standards InstitutionThis part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling.
for filling.

This part of ISO11040 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 ISO11040 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 ISO11040 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO11040.

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 ISO11040.

Committee
CH/212
DocumentType
Standard
ISBN
9780539024845
Pages
60
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 11040-4:2015/Amd 1:2020 Identical

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Hardcopy - English
PDF - English
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