DS/EN ISO 8362-2/A1
Injection containers and accessories – Part 2: Closures for injection vials – Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
| Organization: | DS |
| Publication Date: | 28 September 2022 |
| Status: | active |
| Page Count: | 14 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
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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