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ISO 8536-2:2023

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

Publication date:   Jan 31, 2023

General information

60.60   Standard published   Jan 31, 2023

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

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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WITHDRAWN
ISO 8536-2:2010

NOW

PUBLISHED
ISO 8536-2:2023
60.60 Standard published
Jan 31, 2023