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Standards and Guidance Documents Impacted by the Laboratory of Fluid Dynamics

  • ASTM WK8997: Standard Practice for Analysis of Hemolytic Properties of Medical Nanoparticles
  • ASTM F756-08: Assessment of hemolytic properties of materials 
  • ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood 
  • ASTM F1830: Blood for in vitro evaluation of blood pumps 
  • ASTM F1841: Assessment of hemolysis in continuous flow blood pumps 
  • AAMI/ISO/CD 14708-5: Implants for Surgery – Active implantable medical devices – Part 5: Particular requirements for circulatory support devices 
  • ANSI/AAMI RD17: Hemodialyzer blood tubing
  • ANSI/AAMI RD5: Hemodialysis systems 
  • ISO 7199: Cardiovascular implants and artificial organs: Blood-gas exchangers (oxygenators) 
  • ASTM F2382: Assessment of intravascular medical device materials on partial thromboplastin time (PTT) 
  • CLSI H58: Platelet function testing by aggregometry: Proposed guideline from Clinical and Laboratory Standards Institute (draft) 
  • ISO 5840: Cardiovascular implants -- Cardiac valve prostheses 
  • Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications. Document issued on: January 20, 2010