Biomaterials, Medical Devices, and Combination Products: Biocompatibility Testing and Safety Assessment, 1st Edition (e-Book) book cover

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment, 1st Edition

By Shayne Cox Gad, Samantha Gad-McDonald

CRC Press

606 pages

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pub: 2015-11-24
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Description

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Table of Contents

Safety Evaluation of Medical Devices. Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation. Road Map to Test Selections. Materials in Medical Device Design. What to Test: Sampling and Sample Preparation. Cytotoxicity Testing. Hemocompatibility (ISO 10993-4). Local Tissue Tolerance. Immunotoxicology (ISO 10993-20). Implantation Biology and Studies. Acute Systemic Toxicity Testing and Device Safety Evaluation. Genotoxicity. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. Carcinogenicity. Degradation Products and Impurities Processes in Medical Devices. Special Case Devices. Combination Products. Clinical Studies for Medical Devices. Leachables and Extractables from Medical Devices. Toxicokinetics in Biomaterial and Device Safety Evaluation. Special Studies. Case Histories and Problem Resolution. Appendix A: Selected Regulatory and Toxicological Acronyms. Appendix B: Contract Testing Laboratories. Appendix C: Notable Regulatory Internet Addresses. Appendix D: Non-U.S. Medical Device Regulators.

About the Authors

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USA

Samantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED096000
MEDICAL / Toxicology
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical