Shayne Cox Gad, Samantha Gad-McDonald

Biomaterials, Medical Devices, and Combination Products (eBook, PDF)

Biocompatibility Testing and Safety Assessment

• Format: PDF

Produktbeschreibung

This book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as in the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying, and assessing the risk arising from chemical entities released from market-ready devices. Each aspect of device safety evaluation is reviewed in terms of the ISO, FDA, EU, and MHLW perspectives.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 606
• Erscheinungstermin: 1. Dezember 2015
• Englisch
• ISBN-13: 9781482248388
• Artikelnr.: 44199430

Autorenporträt

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

Inhaltsangabe

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.