ISO/DIS 8536-6

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles ISO/DIS 8536-6

General information

Current stage: 40.20 DIS ballot initiated: 12 weeks Apr 18, 2024

Originator: ISO

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

Type: International Standard

ICS: 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
40.20 DIS ballot initiated: 12 weeks
Apr 18, 2024