000			05239cam a22004094a 4500
001			12619575
003			OSt
005			20150408113723.0
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	0	0	_aR857.M3 _bG33 2002
060	1	0	_aQT 37 _bG123s 2002
082	0	0	_a681/.761/0287 _221
100	1		_aGad, Shayne C., _d1948- _95003
245	1	0	_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. _95004
650		0	_aBiomedical materials _xToxicity testing. _95005
650		0	_aBiocompatibility _xTesting. _95006
650	1	2	_aBiocompatible Materials. _95007
650	1	2	_aMaterials Testing. _95008
650	2	2	_aEquipment Failure. _95009
650	2	2	_aEquipment Safety. _95010
650	2	2	_aToxicity Tests. _95011
856	4	1	_3Table of contents only _uhttp://www.loc.gov/catdir/toc/fy033/2001058401.html
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0648/2001058401-d.html
942			_2ddc _cBOOK
999			_c832 _d235332