Standard Svensk standard · SS-EN ISO 8536-2:2010

Infusionsutrustning för medicinskt bruk - Del 2: Försegling av infusionsflaskor (ISO 8536-2:2010)

Status: Gällande

Omfattning
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO 8536 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.

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)

Artikelnummer: STD-73652

Utgåva: 2

Fastställd: 2010-03-25

Antal sidor: 24

Ersätter: SS-EN ISO 8536-2/AC:2005 , SS-EN ISO 8536-2