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EVS-EN ISO 8536-2:2023

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

General information
Valid from 01.03.2023
Base Documents
ISO 8536-2:2023; EN ISO 8536-2:2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.03.2023
Main
06.05.2010
Main
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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