ISO 8536-2:2023 Infusion equipment for medical use — Part 2: Closures for infusion bottles

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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.
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Status: Active ChangeNumber: 4 InternationalClassificationCodeOfStandards: 11.040.20 TechnicalCommittee: ISO/TC 76 ActivatedDate: 31.01.2023 PagesCount: 12 Language: en

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