DIN EN ISO 8871-4-2006 非肠道及制药设备用弹性件.第4部分:生物学要求和试验方法
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
This part of ISO 8871 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.