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Author Leitgeb, N.
Title Safety of electromedical devices : law, risk and opportunities / Norbert Leitgeb.
Imprint Wien ; London : Springer, 2010.

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Author Leitgeb, N.
Subject Medical instruments and apparatus -- Safety measures.
Products liability -- Medical instruments and apparatus.
Medical instruments and apparatus -- Design and construction -- Standards.
Description 1 online resource (xi, 233 pages) : illustrations
Bibliography Note Includes bibliographical references and index.
Contents Medical devices -- How safe is safe enough?- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electrical safety -- Electromedical devices -- Safety testing.
Summary The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It 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. It explains 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, the book describes which safety requirements are to be met and how they can be satisfied and tested.
Note Print version record.
ISBN 9783211996836
9783211996829 (pbk.)
3211996826 (pbk.)
OCLC # 663096372
Additional Format Print version: Leitgeb, N. Safety of electromedical devices. Wien ; London : Springer, 2010 9783211996829 3211996826 (OCoLC)573059800

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