ISO 8871-2:2020 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 8871-2:2020

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

本文件规定了适用于弹性体零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子。本文件中规定的物理和化学试验程序允许确定弹性体零件的典型特性，包括涂层和表面处理，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。根据弹性体的类型及其应用，选择一组合适的试验。

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.

标准预览图