ISO 11658:2012 心血管植入及体外系统 体外灌注系统用血液/组织接触面修形

标准编号：ISO 11658:2012

中文名称：心血管植入及体外系统 体外灌注系统用血液/组织接触面修形

英文名称：Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

发布日期：2012-05

标准范围

本国际标准规定了以下各项的物理、生物和性能测试要求:体外装置的生物相容性修改。本国际标准适用于部件心脏-肺旁路设备和体外生命支持设备对装置的血液和组织接触表面的修改。假设这些设备将在常规的低温和常温范围内使用。如果指示高温（>；37°C）应用，然后在指示范围内进行测试。

This International Standard specifies requirements for the physical, biological and performance testing ofbiocompatible modifications on extracorporeal devices. This International Standard is applicable to componentsof heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and havemodifications 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. Ifhyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

标准预览图