ENGLISH

Safety of Electromedical Devices: Law — Risks — Opportunities

By Univ.-Prof. Dipl.-Ing. Dr. Norbert Leitgeb (auth.)

Book information

Publisher
Springer-Verlag Wien
Year
2010
ISBN
978-3-211-99682-9, 978-3-211-99683-6
DOI
10.1007/978-3-211-99683-6
Language
english
Format
PDF
Filesize
15 MB (15767725 bytes)
Edition
1
Pages
233\234
Orientation
yes
Scanned
yes
Time added
2013-08-01 04:00:00
Biomedical Engineering

Description

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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