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Safety of Electromedical Devices [electronic resource] :Law — Risks — Opportunities / by Norbert Leitgeb.

by Leitgeb, Norbert [author.]; SpringerLink (Online service).
Material type: materialTypeLabelBookPublisher: Vienna : Springer Vienna, 2010.Description: XI, 233 p. online resource.ISBN: 9783211996836.Subject(s): Engineering | Biomedical engineering | Engineering | Biomedical EngineeringDDC classification: 610.28 Online resources: Click here to access online
Contents:
Medical devices -- How safe is safe enough? -- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electric safety -- Electromedical devices -- Safety testing.
In: Springer eBooksSummary: 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.
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Medical devices -- How safe is safe enough? -- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electric safety -- Electromedical devices -- Safety testing.

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.

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