Biocompatibility Protocols for Medical Devices and Materials
- 1st Edition - April 7, 2023
- Imprint: Academic Press
- Authors: Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran
- Language: English
- Paperback ISBN:9 7 8 - 0 - 3 2 3 - 9 1 9 5 2 - 4
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 8 4 9 2 - 8
Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk asse… Read more
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Request a sales quoteBiocompatibility 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
Toxicologists, industry professionals working in assessment and remediation, R&D, biomedical healthcare, product development officers, medical device stake holders. Graduate students and researchers in toxicology
- Cover image
- Title page
- Table of Contents
- Copyright
- Contributors
- Author bios
- Introduction
- Risk assessment for biocompatibility testing
- Considering existing information to mitigate the risks
- ISO 10993-1: a risk-based approach
- Biocompatibility endpoints evaluation
- Conclusion
- Chapter 1. Cytotoxicity
- Introduction
- ISO 10993-5
- Cytotoxicity
- Detection methods
- Test by indirect contact
- Quantitative method
- Abbreviations
- Chapter 2. Sensitization
- 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
- Chapter 3. Irritation test
- Introduction
- Selection of animals
- Test procedure
- Alternative methods
- In vitro tests methods for irritation
- Chapter 4. Material-mediated pyrogenicity
- 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
- Chapter 5. Acute systemic toxicity
- Introduction
- Considerations
- Chapter 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity)
- Introduction
- Animal care and husbandry
- Size and number of groups
- Routes of exposure
- Dosing
- Clinical observations
- Clinical pathology
- Anatomic pathology
- Evaluation criteria
- Final report
- Chapter 7. Implantation
- Introduction
- Selection of animals
- Test procedure
- Chapter 8. Hemocompatibility
- 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 tests—principles, scientific basis, and interpretation
- Evaluation of hemolytic properties of medical devices and their components
- Hemolysis testing—general considerations
- Abbreviations
- Chapter 9. Tests for genotoxicity
- Introduction
- Requirements
- Genotoxicity
- Example test method: mouse lymphoma mutagenesis assay
- Evaluation criteria
- Results
- Conclusion
- Chapter 10. Carcinogenicity
- Introduction
- Carcinogenicity test-specific considerations
- Abbreviations
- Chapter 11. Reproduction toxicity
- Introduction
- Principle of the test
- Description of the method
- Procedure
- Data and reporting
- Abbreviations
- Chapter 12. Toxicokinetics
- 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
- Chapter 13. Data leverage
- Introduction
- Leverage from literature
- Leverage from Threshold of Toxicological Concern (TTC)
- Leverage from reviewed devices
- Leverage from vendors testing
- Chapter 14. Chemical characterization
- 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
- Chapter 15. Biological evaluation report
- Contents
- Index
- Edition: 1
- Published: April 7, 2023
- Imprint: Academic Press
- No. of pages: 262
- Language: English
- Paperback ISBN: 9780323919524
- eBook ISBN: 9780323984928
PT
Prakash Srinivasan Timiri Shanmugam
Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME–Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts.
Affiliations and expertise
Senior Toxicologist, Avanos Medical, Inc., Georgia, USATS
Thamizharasan Sampath
Thamizharasan Sampath, PhD, PGDCR, is currently Dean of Research and Professor of Pharmacology & Toxicology at the University of Health Sciences (SBIMS), Raipur, CG, India. He has done his MS and PhD specializing in pharmacology under the faculty of medicine from the Post Graduate Institute of Basic Medical Sciences, University of Madras, and also did his Postgraduate diploma in clinical research at State University. He has 17 years of teaching and research experience. His research areas include cancer pharmacology, clinical research, neurotoxicology, nutraceuticals, reproductive toxicology, endocrine pharmacology, phytopharmacology, molecular pharmacology, drug design, and drug discovery. He has published more than 60 research articles in national and international indexed journals and is the author of the book Bamboo - The Golden seed and has also contributed more than 20 book chapters. He has received many awards from various central organizations for his outstanding research and contribution in the field of medicine. He serves as a Chief Editor, Editorial Board Member, and Reviewer in many medical journals. He is a member of Institutional Research Ethics Committee, Animal Ethics Committee, Indian Pharmacological Society, and UNESCO Bioethics Committee.
Affiliations and expertise
Dean of Research and Professor, Department of Pharmacology & Toxicology, Shri Balaji Institute of Medical Sciences, University of Health Sciences, Raipur, Chhattisgarh, IndiaIJ
Indumathy Jagadeeswaran
Indumathy Jagadeeswaran, PhD, is currently working as a Senior Research Associate in the Department of Pediatrics at UT Southwestern Medical Center, Dallas, Texas, United States. She has an MS in Biotechnology with Biochemistry (interdisciplinary) and PhD in Medical Physiology from the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, India. She has been working in the field of physiology since 2011 and has completed her postdoctoral training from prestigious institutes including the UT Southwestern Medical Center, Dallas, Texas. She has editorial experience including being an Associate Editor (2014–2017) for a peer-reviewed international journal and is presently a Peer-Review Member of the Scientific Committee and Society. She has contributed book chapters on regulatory standards and has also published research articles in various peer-reviewed international journals.
Affiliations and expertise
Senior Research Associate, Department of Pediatrics, UT Southwestern Medical Center, Dallas, Texas, U.S.ARead Biocompatibility Protocols for Medical Devices and Materials on ScienceDirect