Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
肠胃外和药物使用设备的弹性部件 - 第5部分:功能要求和测试
发布日期:
2016-10-13
ISO 8871-5:2016规定了与小瓶结合使用的弹性瓶盖功能参数的要求和试验方法,以及注射针刺穿时的功能参数。
注:ISO 8536-2和ISO 8536-6中规定了带尖峰的功能测试。
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536?2 and in ISO 8536?6.