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ISO 8536-2:2023

M00001333

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

standard by International Organization for Standardization, 01/01/2023

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Full Description

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.