标准摘要
[中文适用范围]： 本国际标准规定了体外器械生物相容性改造的物理、生物学和性能测试的要求。 本国际标准适用于心肺旁路设备和体外生命支持设备的部件，这些设备携带血液并对设备的血液和组织接触表面进行了修改。 假设这些设备将在常规的低温和常温范围内使用。 如果指示采用高温（>37°C）应用，则在指示的范围内进行测试。 [外文原描述]： This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.
英文名称Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems