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Overview ISO 8871-1:2003 - “Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates” defines chemical evaluation procedures for elastom…
1 Scope 1.1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including bot…