标准编号：ISO 8871-2:2020
中文名称：肠胃外人造橡胶部件和制药使用设备 第2部分：鉴定和特性记述
英文名称：Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
发布日期：2020-05
标准范围
This document specifies identification and characterization procedures applicable to elastomeric parts
including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination of
the typical characteristics of elastomeric parts including coatings and surface treatments and can
serve as a basis for agreements between manufacturer and user regarding the product consistency in
subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of
tests is selected.
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