标准摘要
[中文适用范围]： 非无菌夹紧组件和流量调节器用于构成输液/ transfusion设备的子组件，以控制静脉溶液和/或血液成分在经过灭菌的输液和 transfusion设备套装以及血液バッグassembly中流动。某些国家，国家级药典或其他国家级法规具有法律约束力并优先于本部分ISO 8536。 [外文原描述]： 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.
英文名称Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact