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EN ISO 8536-2:2023

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

Publication date:   Jun 15, 2023

General information

60.60 Standard published   Feb 15, 2023

CEN

CEN/BT

European Norm

11.040.20   Transfusion, infusion and injection equipment

Buying

Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-2:2010

NOW

PUBLISHED
EN ISO 8536-2:2023
60.60 Standard published
Feb 15, 2023