BAS EN ISO 8536-2:2024
Infusion equipment for medical use - Part 2: Closures for infusion bottles
General Information
Status: Published
No. of pages: 19
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 10.06.2024
Technical committee:
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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