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SSH EN ISO 8536-2:2023

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

Apr 8, 2025

General information

60.60     Apr 8, 2025

95.99   

DPS

DPS/KT 316

European Norm

11.040.20  

English  

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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WITHDRAWN
SSH EN ISO 8536-2:2010

NOW

PUBLISHED
SSH EN ISO 8536-2:2023
60.60 Standard published
Apr 8, 2025

Related project

Adopted from EN ISO 8536-2:2023 IDENTICAL

Adopted from ISO 8536-2:2023 IDENTICAL