ISO 8536-2:2023

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

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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