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Safety evaluation in the development...

Gad, Shayne C., (1948-)

Safety evaluation in the development of medical devices and combination products

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Safety evaluation in the development of medical devices and combination productsShayne C. Gad, Marian G. McCord.
作者:	Gad, Shayne C.,
其他作者:	Gad, Shayne C.,
出版者:	New York :Informa Healthcare,c2008.
面頁冊數:	viii, 300 p. :ill. ;29 cm.
附註:	Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
標題:	Biomedical materialsTesting.
電子資源:	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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