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prEN ISO 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024) prEN ISO 8871-5

Publication date:   Apr 25, 2024

General information

40.20 DIS ballot initiated: 12 weeks   Apr 25, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

Buying

Draft

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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
EN ISO 8871-5:2016

NOW

IN_DEVELOPMENT
prEN ISO 8871-5
40.20 DIS ballot initiated: 12 weeks
Apr 25, 2024