Biocompatibility Protocols for Medical Devices and Materials

ContributorsAuthor biosIntroduction 1.CytotoxicityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan, Safura Fathima and Krithaksha V. IntroductionISO 10993-5CytotoxicityDetection methodsTest by indirect contactQuantitative methodAbbreviationsReferences 2. SensitizationPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction ISO 10993-10 Test methods Guinea pig tests Guinea pig tests and sensitization potency assessment Guinea pig maximization and Buehler tests Open epicutaneous test Advantages and limitations Local lymph node assay The LLNA and sensitization potency assessment Advantages and limitations Human skin-sensitization testing Advantages and limitations Application of test methods in risk assessment Guinea pig tests Local lymph node assay Human repeat-insult patch testAbbreviation References 3. Irritation testPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure Alternative methods In vitro tests methods for irritation References 4. Material-mediated pyrogenicityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction Broad range of pyrogens Tests using fluid extracts Selection of animal species Animal status Animal care and husbandry Size of groups Number of groups Treatment controls Route of exposure Test sample administration Pyrogen tests LAL test Rabbit test: sham test (in vivo) Interpretation of results Monocyte activation test (in vitro test) Procedure of MAT Advantages Abbreviations References 5. Acute systemic toxicityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Considerations Acute systemic toxicity Selection of animals Animal status Animal care and husbandry Size and number of groups Routes of exposure Dosing Body weight and food/water consumption Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity)Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Animal care and husbandry Size and number of groups Routes of exposure Dosing Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 7. ImplantationPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure References 8. HemocompatibilityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Krithaksha V., Vinod P. Bhalerao and Sandhiya Thamizharasan Highlights Introduction Types of devices in contact with blood Characterization of blood interactions Categories of tests and blood interactions Preclinical evaluation of cardiovascular devices and prostheses Advantages and limitations of animal and in vitro testing Laboratory testsdprinciples, scientific basis, and interpretation Evaluation of hemolytic properties of medical devices and their components Hemolysis testingdgeneral considerations Abbreviations References 9. Tests for genotoxicityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Requirements Genotoxicity Example test method: mouse lymphoma mutagenesis assay Evaluation criteria Results Conclusion References 10. CarcinogenicityPrakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Safura Fathima and Sandhiya Thamizharasan Introduction Carcinogenicity test-specific considerations Abbreviations References 11.