Safety Evaluation of Medical Devices / Edition 1

Safety Evaluation of Medical Devices / Edition 1

by Shayne C. Gad
     
 

ISBN-10: 0824798279

ISBN-13: 9780824798277

Pub. Date: 01/28/1997

Publisher: Taylor & Francis

This practical reference examines the implications of biological and chemical interactions of medical devices with human tissue - offering comprehensive coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems. Discussing preapproval and ongoing test requirements…  See more details below

Overview

This practical reference examines the implications of biological and chemical interactions of medical devices with human tissue - offering comprehensive coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems. Discussing preapproval and ongoing test requirements necessary for the development of new products, Safety Evaluation of Medical Devices shows how to select individual materials, components, or devices for testing and how to prepare the samples selected...explains cytotoxicity testing for the determination of biocompatibility using mammalian cell cultures...details the evaluation of hemocompatibility and the potential adverse effects of medical devices on the immune system...addresses studies for both short- and long-term implantable devices...delineates possible genotoxic effects of device materials...presents appropriate models for clinical studies of medical devices...describes specialized studies for cardiovascular prostheses, contact lenses and solutions, and tampons as well as the "mouse safety" systemic injection test...and much more.

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Product Details

ISBN-13:
9780824798277
Publisher:
Taylor & Francis
Publication date:
01/28/1997
Pages:
387
Product dimensions:
7.48(w) x 10.63(h) x (d)

Table of Contents

Preface
1Introduction1
2Road Map to Test Selections27
3What to Test: Sampling and Sample Preparation65
4Cytotoxicity Testing75
5Blood Compatibility85
6Irritation and Pyrogenicity97
7Immunotoxicology131
8Implantation Studies189
9Genotoxicity209
10Subchronic and Chronic Toxicity259
11Carcinogenicity and Reproductive and Developmental Toxicity271
12Sterility, Sterilization, and Heavy Metals305
13Clinical Studies for Medical Devices317
14Special Studies and Special Cases339
15Case Histories and Problem Resolution363
Appendix: Selected Acronyms381
Index383

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