Gad / Gad-McDonald Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment
1. Auflage 2015
ISBN: 978-1-4822-4838-8
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 606 Seiten

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, and 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.

Autoren/Hrsg.

Gad, Shayne Cox

Gad-McDonald, Samantha

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Medizinische Biotechnologie
• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Introduction
Global Regulatory Requirements and Strategy in Medical Device and Bio Materials Assessment
Road Map to Test Selections (510(k), IDE)
Materials in Medical Device Design: Polymers, Metals, Ceramics, and Additives
Sample Selection and Preparation
Cytotoxicity Testing
Hemocompatibility
Local Tissue Tolerance
Immunotoxicology
Implantation Biology and Studies
Acute Systemic Toxicity Testing Device Safety Evaluation
Genotoxicity
Subchronic and Chronic Toxicity and reproductive and Developmental Toxicity
Carcinogenicity
Leachables and Extractables
Combination Products
Degradation Products
Clinical Studies for Medical Devices
Special Studies
New Materials and Products
Toxicokinetics in Biomaterial and Device Safety Evaluation
Case Histories and Problem Resolution
Historical Failures and Recalls
Appendix A: Selected Regulatory and Toxicological Acronyms and Abbreviations
Appendix B: Contract Testing Laboratories
Appendix C: Notable International Regulatory Internet Addresses
Appendix D: Global Medical Device Regulators