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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…
Overview EN ISO 8871-1:2004 (ISO 8871-1:2003) specifies chemical test methods to classify and evaluate elastomeric parts for parenterals and pharmaceutical devices by determining extractables in aque…
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…
