Safety of electromedical devices : law, risk and opportunities / Norbert Leitgeb.

By:

Leitgeb, N

Material type: Text

TextWien ; New York : Springer c2010Description: xi, 233 p. : illustrations ; 25 cmContent type:

text

Media type:

unmediated

Carrier type:

volume

ISBN:

9783211996829 (pbk.)
3211996826 (pbk.)

Subject(s):

DDC classification:

23 610.28 L.N.S

LOC classification:

R856.6 .L44 2010

Contents:

Summary: In his new book, Norbert Leitgeb discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. He describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. Leitgeb explains comprehensively how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, he describes which safety requirements are to be met and how they can be satisfied and tested. --Résumé de l'éditeur.

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Holdings
Item type	Current library	Collection	Call number	Copy number	Status	Date due	Barcode
Books	Main library A10	Faculty of Engineering & Technology (Biomedical)	610.28 L.N.S (Browse shelf(Opens below))	1	Available		00015764

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Previous	610.28 H V.3 Hydrogels in medicine and pharmacy /	610.28 I Integrated biomaterials for biomedical technology /	610.28 K.R.B Bio-Medical signal processing /	610.28 L.N.S Safety of electromedical devices : law, risk and opportunities /	610.28 L.P.F Fundamentals of microfluidics and lab on a chip for biological analysis and discovery /	610.28 M Microfluidics and microfabrication /	610.28 M Mechatronics in medicine : a biomedical engineering approach /	Next

Includes bibliographical references (p. [215]-219) and index.

Medical devices.- How safe is safe enough?.- Application safety.- Biocompatibility.- Hygiene.- Environmental safety.- Ecological safety.- Electric safety.- Electromedical devices.- Safety testing.

In his new book, Norbert Leitgeb discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. He describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. Leitgeb explains comprehensively how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, he describes which safety requirements are to be met and how they can be satisfied and tested. --Résumé de l'éditeur.

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