ASTM F1841-97(2017) PDF

Scope: 1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump’s effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h. 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 and health 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.

ASTM F1841-97(2017) Referenced Document

ASTM F1830 Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

2019 ASTM F1841-19e1 Standard operating procedure for assessment of hemolysis in continuous flow blood pumps
2019 ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
2017 ASTM F1841-97(2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
1997 ASTM F1841-97(2013) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
1997 ASTM F1841-97(2005) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
1997 ASTM F1841-97 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps