标准摘要
[中文适用范围]： 本文件规定了适用于弹性体部件的识别和表征程序，包括用于药物容器和医疗器械的涂层塞。 本文件中规定的物理和化学测试程序可以确定弹性体部件的典型特性，包括涂层和表面处理，并可以作为制造商和用户之间就后续供应中的产品一致性达成协议的基础。 根据弹性体的类型及其应用，选择一组适当的测试。 [外文原描述]： 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.
英文名称Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization