05239cam a22004094a 4500 12619575 OSt 20150408113723.0 011213s2002 nyua b 001 0 eng 2001058401 082470617X (alk. paper) (DNLM)101134533 DNLM/DLC DLC DLC pcc R857.M3 G33 2002 QT 37 G123s 2002 681/.761/0287 21 Gad, Shayne C., 1948- 5003 Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., rev. and expanded. New York : M. Dekker, c2002. xii, 558 p. : ill. ; 23 cm. Includes bibliographical references and index. Machine generated contents note: Preface to the Second Edition -- Preface to the First Edition -- 1 Introduction -- I. Biocompatibility -- II. Scope of Devices and the Medical Device Market -- III. History -- IV. Nonspecific Regulatory Considerations -- References -- 2 Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation -- I. Regulatory Basis -- II. Toxicity Testing: Medical Devices -- References -- 3 Road Map to Test Selections -- I. Key Concepts -- II. Conditions of Use -- III. Materials, Components, and Products -- IV. Prior Knowledge -- V. Types and Uses of Tests -- References -- 4 What to Test: Sampling and Sample Preparation -- I. Sampling -- II. Randomization -- III. Sample Preparation -- IV. Reference Materials -- V. Conclusion -- References -- 5 Cytotoxicity Testing -- I. Background -- II. Cytotoxicity Assays -- III. Conclusion -- References -- 6 Blood Compatibility -- I. Introduction -- II. Standard Tests -- III. Conclusion -- References -- 7 Irritation and Pyrogenicity -- I. Dermal Irritation -- II. Ocular Irritation Testing -- III. Other Nonparenteral Route Irritation Tests -- IV. Parenteral Irritation/Tolerance -- V. Parenteral Routes -- VI. Intracutaneous Irritation -- VII. Problems in Testing (and Their Resolutions) -- References -- 8 Immunotoxicology -- I. Overview of the Immune System -- II. Evaluation of the Immune System -- III. Local Lymph Node Assay -- IV. Approaches -- V. Problems and Future Directions -- References -- 9 Implantation Biology and Studies -- I. USP Implantation Test -- II. British Pharmacopoeia -- III. ISO 10993 Implantation Test -- IV. Test Method for Implantation in Subcutaneous Tissue -- V. Test Method for Implantation in Muscle -- VI. Test Method for Implantation in Bone -- VII. Control Materials -- VIII. Long-Term Implant Studies -- IX. Considerations -- References -- 10 Genotoxicity -- I. DNA Structure -- II. Cytogenetics -- III. In Vitro Cytogenetic Assays -- IV. In Vivo Cytogenetic Assays -- V. Sister Chromatid Exchange Assays -- References -- 11 Subchronic and Chronic Toxicity and Reproductive and -- Developmental Toxicity -- I. Objectives -- II. Regulatory Considerations -- III. Parameters to Measure -- IV. Histopathology -- V. Study Interpretation and Reporting -- VI. Reproductive and Developmental Toxicity -- References -- 12 Carcinogenicity -- I. Animal Model -- II. Dose Selection -- III. Interpretation of Results -- References -- 13 Sterility, Sterilization, and Heavy Metals -- I. Sterility -- II. Heavy Metals -- References -- 14 Combination Devices -- I. Combination Products -- II. Device Programs that CDER and CBRH Will Administer -- References -- 15 Clinical Studies for Medical Devices -- I. Design Considerations -- II. Epidemiology -- III. Conclusion -- References -- 16 Special Studies -- I. Cardiovascular Devices and Prostheses -- II. Tampons -- III. Contact Lenses and Their Solutions -- IV. Specific Tests -- V. Twenty-One-Day Eye Irritation Study in Rabbits -- VI. Systemic Injection Test -- VII. Production of Toxic Shock Syndrome Toxin-l (TSST-1) -- VIII. In Vitro Evaluation of the Effects of Potential Tampon -- Materials on pH and Growth of Vaginal Microflora -- IX. Inflammatory Responses to Biomaterials -- References -- 17 Case Histories and Problem Resolution -- I. Phthalate and Other Residuals Leaching from Devices -- II. Dalkon Shield -- III. Talc on Gloves and Condoms -- IV. Toxic Shock Syndrome -- V. Latex Allergy -- VI. Silicones in Devices -- VII. Problem Solving -- VIII. Risk Assessments -- IX. Conclusion -- References -- Appendix A: Selected Regulatory and Toxicological Acronyms -- and Abbreviations -- Appendix B: Contract Testing Laboratories -- Appendix C: Notable Regulatory Internet Addresses -- Appendix D: Non-U.S. Medical Device Regulators -- Index. Biomedical materials Testing. 5004 Biomedical materials Toxicity testing. 5005 Biocompatibility Testing. 5006 Biocompatible Materials. 5007 Materials Testing. 5008 Equipment Failure. 5009 Equipment Safety. 5010 Toxicity Tests. 5011 Table of contents only http://www.loc.gov/catdir/toc/fy033/2001058401.html Publisher description http://www.loc.gov/catdir/enhancements/fy0648/2001058401-d.html ddc BOOK 832 235332 0 2013-03-10 0 0 681.7610287 G S S 2011-09-29 CL 00049027 CL 2013-03-10 00:00:00 BOOK ddc 0