Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
用于医疗用途的输液设备 - 第14部分:无流体接触的输液和输液设备的夹具和流量调节器
发布日期:
2016-11-04
ISO 8536-14:2016规定了作为子部件使用的非无菌夹和流量调节器的要求,以控制静脉注射溶液和/或血液成分通过无菌输液器、输血器和血袋组件的流量,而不与液体接触。
在一些国家,国家药典或其他国家法规具有法律约束力,优先于ISO 8536-14:2016。
ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.