ISO/DIS 8536-6

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

General information

Current stage: 40.60 Effective date: Jul 12, 2024

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.20

Languages: English

Buying

Status: Draft

PDF - ALL 7,123

Paper - ALL 7,123

CD - ALL 7,123

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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

Revises
ISO 8536-6:2016

NOW

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

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