0

ISO 8536-2:2023

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

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

Buying

Published

Language in which you want to receive the document.

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WITHDRAWN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