Tracked Changes. Infusion equipment for medical use Closures for infusion bottles
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Standard number:
BS EN ISO 8536-2:2023 - TC
Pages:
52
Released:
2023-02-23
ISBN:
978 0 539 26103 5
Status:
Tracked Changes
DESCRIPTION
BS EN ISO 8536-2:2023 - TC
This standard BS EN ISO 8536-2:2023 - TC Tracked Changes. Infusion equipment for medical use is classified in these ICS categories:
11.040.20 Transfusion, infusion and injection equipment
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.
