
Elastomeric Parts For Parenterals And For Devices For Pharmaceutical Use - Part 1: Extractables In Aqueous Autoclavates
出版:Nederlands Normalisatie Instituut

专家解读视频
Defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates and explains the various fields of application for elastomeric parts.
ISO 8871-1:2003 - Identical