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SRPS EN ISO 8536-2:2023

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

Mar 30, 2023
Mar 31, 2025

General information

60.60     Mar 30, 2023

ISS

Z076

European Norm

11.040.20  

English   Serbian  

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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WITHDRAWN
SRPS EN ISO 8536-2:2012

NOW

PUBLISHED
SRPS EN ISO 8536-2:2023
60.60 Standard published
Mar 30, 2023

Related project

Adopted from EN ISO 8536-2:2023

Adopted from ISO 8536-2:2023 IDENTICAL