ČSN EN ISO 8536-2

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

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Detail information

Designation: ČSN EN ISO 8536-2

Publication date: 01/08/2023

Pages: 28

Country: Czech technical standard

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Anotation

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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