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prSRPS EN ISO 8871-4:2025

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods

General information

10.99     Oct 14, 2025

ISS

Z076

European Norm

English  

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
SRPS EN ISO 8871-4:2010

NOW

PROJECT
prSRPS EN ISO 8871-4:2025
10.99 New project approved
Oct 14, 2025

Related project

Adopted from prEN ISO 8871-4 rev IDENTICAL

Adopted from ISO/AWI 8871-4 IDENTICAL