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EVS-EN ISO 8362-2:2015+A1:2022

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015 + ISO 8362-2:2015/Amd 1:2022)

General information
Valid from 15.05.2023
Base Documents
ISO 8362-2:2015; EN ISO 8362-2:2015; ISO 8362-2:2015/Amd 1:2022; EN ISO 8362-2:2015/A1:2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 8362-2
15.05.2023
Main + amendment
03.10.2022
Amendment
03.12.2015
Main
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362 1 and ISO 8362 4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single use only.
NOTE  The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
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