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Safety evaluation of medical devices

Author: Shayne C Gad
Publisher: New York : M. Dekker, ©2002.
Edition/Format:   Print book : English : 2nd ed., rev. and expandedView all editions and formats
Summary:

The second edition of this text contains a new chapter on US, EEC, and Japanese regulatory matters, and topical information on combination equipment, contract testing labs and Internet sites.

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Shayne C Gad
ISBN: 082470617X 9780824706173
OCLC Number: 48656143
Description: xii, 558 pages : illustrations ; 23 cm
Contents: 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.
Responsibility: Shayne Cox Gad.
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"Praise for the first edition. . . ....discuss[es]...highly relevant case histories.... ....the quantity of practical information...makes this book very worthwhile." ---Instrumentation Science and Read more...

 
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