Safety evaluation in the development of medical devices and combination products /

Bibliographic Details
Main Author: Gad, Shayne C., 1948-
Other Authors: McCord, Marian G.
Format: Book
Language:English
Published: New York : Informa Healthcare, [2008]
Edition:Third edition.
Subjects:

MARC

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100 1 |a Gad, Shayne C.,  |d 1948- 
245 1 0 |a Safety evaluation in the development of medical devices and combination products /  |c Shayne C. Gad, Marian G. McCord. 
250 |a Third edition. 
264 1 |a New York :  |b Informa Healthcare,  |c [2008] 
264 4 |c ©2008 
300 |a viii, 300 pages :  |b illustrations ;  |c 29 cm. 
336 |a text  |2 rdacontent  |b txt 
337 |a unmediated  |2 rdamedia 
338 |a volume  |2 rdacarrier  |b nc 
500 |a Revised edition of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd edition, Rev. and expanded. c2002. 
504 |a Includes bibliographical references and index. 
505 0 |a Regulatory aspects and strategy in medical device and bio materials safety evaluation -- Road map to test selections -- Materials in medical device design -- What to test : sampling and sample preparation -- Cytotoxicity testing -- Hematocompatibiity -- Local tissue tolerance -- Immunotoxicology -- Implantation biology and studies -- Acute systemic testing device safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity and reproductive and developmental toxicity -- Carcinogenicity -- Degradation products and impurties -- Combination products -- Clinical studies for medical devices -- Special studies -- Toxicokinetics in biomaterial and device safety evaluation -- Case histories and problem resolution. 
650 0 |a Biomedical materials  |x Testing. 
650 0 |a Biomedical materials  |x Toxicity testing. 
650 0 |a Biocompatibility  |x Testing. 
650 2 |a Biocompatible Materials. 
650 2 |a Materials Testing. 
650 2 |a Equipment Failure. 
650 2 |a Equipment Safety. 
650 2 |a Toxicity Tests. 
700 1 |a McCord, Marian G. 
700 1 |a Gad, Shayne C.,  |d 1948-  |t Safety evaluation of medical devices. 
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