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ISO/DIS 8536-6

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

General information

40.60 Close of voting   Jul 12, 2024

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

Scope

ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 8536-6:2016

NOW

IN_DEVELOPMENT
ISO/DIS 8536-6
40.60 Close of voting
Jul 12, 2024