nsBAS EN ISO 8536-2:2024
Infusion equipment for medical use - Part 2: Closures for infusion bottles
General information
Status:Project
Number of pages:19
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.20, Transfusion, infusion and injection equipment
Abstract
This document 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 document 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.
Lifecycle
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Original document and degree of correspondence
EN ISO 8536-2:2023, identical
ISO 8536-2:2023, identical
Relation to BAS standards
Work material
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