Biocompatibility Protocols for Medical Devices and Materials

Contributors
Author bios
Introduction

1.Cytotoxicity
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan, Safura Fathima and Krithaksha V.

Introduction
ISO 10993-5
Cytotoxicity
Detection methods
Test by indirect contact
Quantitative method
Abbreviations
References

2. Sensitization
Prakash 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 test
Abbreviation
References

3. Irritation test
Prakash 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 pyrogenicity
Prakash 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 toxicity
Prakash 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. Implantation
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran

Introduction
Selection of animals
Test procedure
References

8. Hemocompatibility
Prakash 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 genotoxicity
Prakash 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. Carcinogenicity
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Safura Fathima and Sandhiya Thamizharasan

Introduction
Carcinogenicity test-specific considerations
Abbreviations
References

11. Reproduction toxicity
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima

Introduction
Principle of the test
Description of the method
Procedure
Data and reporting
Abbreviations
References

12. Toxicokinetics
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Vinod P. Bhalerao, Sandhiya Thamizharasan, Krithaksha V. and Jayanta Saha

Introduction
Principles for design of toxicokinetic studies
Guidance on test methods
Toxicokinetic study sampling
Toxicokinetic study report
Guidance on specific types of test
Absorption
Distribution
Metabolism and excretion
Abbreviations
References

13. Data leverage
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran

Introduction
Leverage from literature
Leverage from Threshold of Toxicological Concern (TTC)
Leverage from reviewed devices
Leverage from vendors testing
References

14. Chemical characterization
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Krithaksha V.

Introduction
Why characterize materials?
Chemical characterization
Material characterization
Plasticizers
Sterilization techniques used for medical devices
Corrosion
Extractables and leachables
Set up a chemical characterization study
Conclusion
References

15. Biological evaluation report
Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran

Contents
Index