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ISO 8536-2:2023

Infusion equipment for medical use — Part 2: Closures for infusion bottles
31 jan 2023

General information

60.60     31 jan 2023

ISO

ISO/TC 76

International Standard

11.040.20  

anglisht   frëngjisht  

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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

Revises
ISO 8536-2:2010

NOW

PUBLISHED
ISO 8536-2:2023
60.60 Standard published
31 jan 2023

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