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Biocompatibility Protocols for Medical Devices and Materials

Autor Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran
en Limba Engleză Paperback – 11 apr 2023
Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.
Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices.


  • Explains the biocompatibility test protocols for medical devices
  • Provides an overview about chemical characterization
  • Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies
  • Discusses the basic points needed to leverage the data from another device
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Specificații

ISBN-13: 9780323919524
ISBN-10: 0323919529
Pagini: 262
Dimensiuni: 152 x 229 x 17 mm
Greutate: 0.36 kg
Editura: ELSEVIER SCIENCE

Cuprins


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