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EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) EN ISO 8362-5:2016

Publication date:   Jun 16, 2016

General information

60.60 Standard published   Mar 16, 2016

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
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 be strongly affected by the nature and performance of the primary packaging.

Life cycle

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PUBLISHED
EN ISO 8362-5:2016
60.60 Standard published
Mar 16, 2016