ISO 8871-2-2003 非肠道及制药设备用弹性件.第2部分:鉴别和表征

标准号：ISO 8871-2-2003
中文标准名称：非肠道及制药设备用弹性件.第2部分:鉴别和表征
英文标准名称：Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
标准类型：C36
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C36
国际标准分类号：11.040.20
适用范围：This part of ISO 8871 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.