Testing & Simulation for Artificial Organs
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Questions and Answers

What is the significance of biological systems being highly complex?

  • It makes in vitro and in vivo testing unnecessary
  • It simplifies the mechanistic understanding of systems
  • It requires virtual exploration of many scenarios to understand (correct)
  • It allows for easy development of therapies and devices

    • What is the purpose of discretizing the geometry in Computational Fluid Dynamics?

  • To eliminate the need for virtual exploration
  • To make the system less complex
  • To model flow physics (correct)
  • To simplify the regulatory pipeline for medical devices

    • Why is it impossible to understand biological systems without computers?

  • Because biological systems are highly complex (correct)
  • Because the regulatory pipeline for medical devices is too complex
  • Because therapies and devices cannot be developed without computers
  • Because in vitro and in vivo testing are not effective

    • What does ISO 10993 specify?

    <p>General standards for biological evaluation of medical devices</p> Signup and view all the answers

    What is the main focus of testing according to the text?

    <p>Biocompatibility</p> Signup and view all the answers

    What is the purpose of biocompatibility testing?

    <p>To assess the material's ability to perform with an appropriate host response</p> Signup and view all the answers

    Which organization participates as a member in ISO?

    <p>DIN (German Institute for Standardization)</p> Signup and view all the answers

    What does ISO 14708 specify?

    <p>Device-specific standards for circulatory support devices</p> Signup and view all the answers

    What is the definition of biocompatibility according to the given text?

    <p>The ability of a material to perform with an appropriate host response</p> Signup and view all the answers

    What is the main purpose of hemocompatibility testing?

    <p>To assess the interaction of blood components with artificial material</p> Signup and view all the answers

    What is thrombogenesis primarily associated with in hemocompatibility testing?

    <p>High shear rates and regions of stasis</p> Signup and view all the answers

    In the context of in-vitro thrombogenicity testing, what does Virchow triad refer to?

    <p>Blood flow, endothelial injury, hypercoagulability</p> Signup and view all the answers

    What are the limitations of pressure testing in in-vitro thrombogenicity?

    <p>Non-standardized test setups and analyses</p> Signup and view all the answers

    What is the '3R' principle mentioned in the context of in-vivo hemocompatibility testing?

    <p>Replace, Reduce, Refine</p> Signup and view all the answers

    What is the primary reason for using mock circulation loops in testing?

    <p>Simulation of pressure and flow in the circulatory system</p> Signup and view all the answers

    What do numerical simulations specifically calculate in the context of testing?

    <p>Flow fields</p> Signup and view all the answers

    What are the specific biological characteristics assessed in a centrifugal blood pump during testing?

    <p>Sterility and non-pyrogenicity</p> Signup and view all the answers

    What does the HQ curve primarily illustrate in relation to a blood pump?

    <p>Hydraulic performance vs. pressure vs. flow</p> Signup and view all the answers

    What does NIH stand for in the context of hemolysis testing?

    <p>Normalized Index of Hemolysis</p> Signup and view all the answers

    Why is modeling important in medical device testing?

    <p>To reduce animal trials and further develop tests</p> Signup and view all the answers

    What does PIV visualization primarily help with during testing?

    <p>Visualization of flow field</p> Signup and view all the answers

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