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Safety evaluation in the development...

Gad, Shayne C., (1948-)

Safety evaluation in the development of medical devices and combination products

Record Type:	Electronic resources : Monograph/item
Title/Author:	Safety evaluation in the development of medical devices and combination productsShayne C. Gad, Marian G. McCord.
Author:	Gad, Shayne C.,
other author:	Gad, Shayne C.,
Published:	New York :Informa Healthcare,c2008.
Description:	viii, 300 p. :ill. ;29 cm.
Notes:	Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
Subject:	Biomedical materialsTesting.
Online resource:	http://www.loc.gov/catdir/toc/ecip0821/2008027552.html
ISBN:	9781420071641 (hardcover : alk. paper)

Safety evaluation in the development of medical devices and combination products
Gad, Shayne C.,1948-

Safety evaluation in the development of medical devices and combination products[electronic resource] /Shayne C. Gad, Marian G. McCord. - 3rd ed. - New York :Informa Healthcare,c2008. - viii, 300 p. :ill. ;29 cm.

Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.

Includes bibliographical references and index.

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.

ISBN: 9781420071641 (hardcover : alk. paper)

LCCN: 2008027552

Nat. Bib. Agency Control No.: 101477067DNLMSubjects--Topical Terms:

301933
Biomedical materials
--Testing.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: R857.M3 / G33 2008

Dewey Class. No.: 610.28/4

National Library of Medicine Call No.: 2008 N-074

Safety evaluation in the development of medical devices and combination products
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245 1 0 $a Safety evaluation in the development of medical devices and combination products $h [electronic resource] / $c Shayne C. Gad, Marian G. McCord.
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260 $a New York : $b Informa Healthcare, $c c2008.
300 $a viii, 300 p. : $b ill. ; $c 29 cm.
500 $a Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., 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. $3 301933
650 0 $a Biomedical materials $x Toxicity testing. $3 301934
650 0 $a Biocompatibility $x Testing. $3 301935
650 1 2 $a Biocompatible Materials. $3 239567
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650 2 2 $a Equipment Failure. $3 190465
650 2 2 $a Equipment Safety. $3 301937
650 2 2 $a Toxicity Tests. $3 301938
655 7 $a Electronic books. $2 local. $3 214472
700 1 $a Gad, Shayne C., $d 1948- $3 225998
700 1 $a McCord, Marian G. $3 488213
856 4 1 $3 Table of contents only $u http://www.loc.gov/catdir/toc/ecip0821/2008027552.html
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