ISO 8871-2:2003 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

标准编号：ISO 8871-2:2003

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：2003-10

标准范围

ISO 8871-2:2003规定了适用于药品容器和医疗器械用弹性体零件的评估程序，以确保（适用性测试）验收过程中评估的样品与当前供应的产品之间的一致性。ISO 8871本部分规定的物理和化学试验程序允许测定橡胶材料的典型特性，并可作为制造商和用户就后续供应中产品一致性达成协议的基础。根据橡胶类型及其应用，选择一组合适的试验。ISO 8871的本部分未规定橡胶材料的其他要求。这些在相关产品标准中有规定。

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

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