Standard Svensk standard · SS-EN ISO 8362-5:2016

Behållare för injektionsvätskor - Del 5: Frystorkningsproppar till injektionsflaskor (ISO 8362-5:2016)

Status: Gällande

Omfattning
This part of ISO 8362 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.

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

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

Artikelnummer: STD-8019627

Utgåva: 1

Fastställd: 2016-03-22

Antal sidor: 24