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ISO/FDIS 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing

General information

50.00 Final text received or FDIS registered for formal approval   Dec 2, 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 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 8871-5:2016

NOW

IN_DEVELOPMENT
ISO/FDIS 8871-5
50.00 Final text received or FDIS registered for formal approval
Dec 2, 2024