MARC Record from Library of Congress

LEADER: 05076cam a22003734a 4500
001 2001058401
003 DLC
005 20111216081939.0
008 011213s2002 nyua b 001 0 eng
010 $a 2001058401
020 $a082470617X (alk. paper)
035 $a(DNLM)101134533
040 $aDNLM/DLC$cDLC$dDLC
042 $apcc
050 00 $aR857.M3$bG33 2002
060 10 $aQT 37$bG123s 2002
082 00 $a681/.761/0287$221
100 1 $aGad, Shayne C.,$d1948-
245 10 $aSafety evaluation of medical devices /$cShayne Cox Gad.
250 $a2nd ed., rev. and expanded.
260 $aNew York :$bM. Dekker,$cc2002.
300 $axii, 558 p. :$bill. ;$c23 cm.
504 $aIncludes bibliographical references and index.
505 8 $aMachine 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.
650 0 $aBiomedical materials$xTesting.
650 0 $aBiomedical materials$xToxicity testing.
650 0 $aBiocompatibility$xTesting.
650 12 $aBiocompatible Materials.
650 12 $aMaterials Testing.
650 22 $aEquipment Failure.
650 22 $aEquipment Safety.
650 22 $aToxicity Tests.
856 41 $3Table of contents only$uhttp://www.loc.gov/catdir/toc/fy033/2001058401.html
856 42 $3Publisher description$uhttp://www.loc.gov/catdir/enhancements/fy0648/2001058401-d.html