TY  - BOOK
AU  - Leitgeb,N.
TI  - Safety of electromedical devices: law, risk and opportunities 
SN  - 9783211996829 (pbk.)
AV  - R856.6 .L44 2010
U1  - 610.28 23
PY  - 2010///
CY  - Wien, New York
PB  - Springer
KW  - Medical instruments and apparatus
KW  - Safety measures
KW  - Products liability
KW  - Design and construction
KW  - Standards
N1  - 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

N2  - 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
ER  -