标准摘要
[中文适用范围]: ISO 8871 的这一部分规定了注射用弹性体部件和药用设备的生物学要求。 它还规定了试验方法,即提供了弹性体部件的提取程序,并参考了药典和标准中的相关生物试验说明。 [外文原描述]: ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.
英文名称Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods