LEADER 00000cam  2200289Ia 4500 
001    9780824706173 
003    FlBoTFG 
005    20060728190029.0 
008    011213s2002    nyua     b    001 0 eng   
010    2001058401 
020    9780824706173 
020    082470617X (alk. paper) 
040    DNLM/DLC|cDLC|dDLC|dFlBoTFG 
050 00 R857.M3|bG33 2002 
092    681.7610287|bG123 
100 1  Gad, Shayne C.,|d1948- 
245 10 Safety evaluation of medical devices /|cShayne Cox Gad 
250    2nd ed., rev. and expanded 
260    New York :|bM. Dekker,|c2002 
300    xii, 558 p. :|bill. ;|c23 cm 
504    Includes bibliographical references and index 
505 8  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 
530    Also available as an electronic resource 
590    TAEBC 
650  0 Biomedical materials|xTesting 
650  0 Biomedical materials|xToxicity testing 
650  0 Biocompatibility|xTesting 
856 40 http://www.crcnetbase.com/isbn/9780824706173
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