ISO 8871-4:2006 肠胃外人造橡胶部件和制药使用设备 第4部分:生物学要求与试验
标准编号:ISO 8871-4:2006
中文名称:肠胃外人造橡胶部件和制药使用设备 第4部分:生物学要求与试验
英文名称:Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods
发布日期:2006-06
标准范围
ISO 8871-4:2006规定了非肠道用弹性体零件和制药设备的生物学要求。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。
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.
标准预览图


