1.1 本规程涵盖了用于循环辅助（包括体外、经皮和植入式设备）的连续、间歇和脉动流血泵的溶血性能评估方案。根据泵在一定时间内对红细胞的影响进行评估。采用当前的评估实践，6小时 体外 该测试是在放置在设备特定再循环血液回路中的泵上进行的，该回路模拟了设备预期最坏临床使用情况下的压力和流量条件。如果测试的最终目标是评估临床使用的泵的血液损伤潜力，则建议使用匹配血液测试回路中的相同血池在受试者血泵和合法上市的比较器设备之间进行配对测试，以便进行相对溶血比较。 1.2 以国际单位制或英寸-磅单位表示的数值应单独视为标准值。每个系统中规定的值可能不是精确的等效值；因此，每个系统应相互独立使用。将两个系统的值合并可能会导致不符合标准。 1.3 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 6.1 本规程的目的是规范评估用于体外循环和/或循环辅助的血泵溶血效果的评估方法。通过配对测试比较受试设备和对照设备之间的溶血结果，可以对受试设备的溶血进行相对评估。

1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. Adopting current practices for this assessment, a 6-hour in vitro test is performed on a pump placed in a device-specific recirculating blood loop that mimics the pressure and flow conditions of the expected worst-case clinical use of the device. If the ultimate goal of the testing is to evaluate the blood damage potential of a pump for clinical use, it is suggested that paired testing between the subject blood pump and a legally marketed comparator device be conducted using the same blood pool in a matched blood test loop so that a relative hemolysis comparison can be made. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 6.1 The objective of this practice is to standardize the evaluation method for assessing the hemolytic effect of a blood pump used in extracorporeal circulation and/or circulatory assistance. By comparing the hemolysis results between a subject device and a comparator device through paired testing, a relative evaluation of hemolysis for the subject device can be made.