Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods

Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods

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1   Scope

This part of ISO 8871 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.