prEN ISO 8871-4 rev

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods prEN ISO 8871-4 rev

General information

10.99   New project approved   Oct 14, 2025

CEN

CEN/TC 205 Non-active medical devices

European Norm

Scope

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 8871-4:2006

NOW

IN_DEVELOPMENT
prEN ISO 8871-4 rev
10.99 New project approved
Oct 14, 2025




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