Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

AvShayne Cox Gad,Samantha Gad-McDonald

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Beskrivning

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

Produktinformation

Utgivningsdatum:2015-12-01
Språk:Engelska
Filformat:PDF
Kopieringsskydd:LCP
ISBN:9781482248388
Förlag:Taylor & Francis Ltd

Utforska kategorier

Hälso- och sjukvårdsrätt inom Juridik
Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin

Mer om författaren

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USASamantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

Innehållsförteckning

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.