【国外标准】 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

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.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.