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ISO/FDIS 11040-7

Superseded

Superseded

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

02-29-2024

Superseded date

06-03-2024

US$193.00
Excluding Tax where applicable

This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.

NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.

NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

Committee
ISO/TC 76
DocumentType
Draft
Pages
25
PublisherName
International Organization for Standardization
RevisionOf
Status
Superseded

US$193.00
Excluding Tax where applicable