| Document Type
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BL
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| Record Number
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1044987
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| Doc. No
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b799357
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| Main Entry
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Gad, Shayne C.,1948-
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| Title & Author
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Safety evaluation of medical devices /\ Shayne Cox Gad.
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| Edition Statement
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2nd ed., rev. and expanded.
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| Publication Statement
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New York :: M. Dekker,, ©2002.
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| Page. NO
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xii, 558 pages :: illustrations ;; 23 cm
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| ISBN
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082470617X
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: 9780824706173
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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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.
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| Subject
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Biocompatibility-- Testing.
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Biomedical materials-- Testing.
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Biomedical materials-- Toxicity testing.
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Biocompatibility-- Testing.
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Biomaterial
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Biomedical materials-- Testing.
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Biomedical materials-- Testing.
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Biomedical materials-- Toxicity testing.
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Biomedical materials-- Toxicity testing.
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Sicherheitstestung
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Biocompatible Materials.
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Materials Testing.
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Equipment Failure.
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Equipment Safety.
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Toxicity Tests.
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| Dewey Classification
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681/.761/0287
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| LC Classification
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R857.M3G33 2002
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| NLM classification
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2002 C-013
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QT 37G123s 2002
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YI 3200rvk
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