Safety of Electromedical Devices Law - Risk - Opportunities

Name: Safety of Electromedical Devices Law - Risk - Opportunities
Availability: InStock
ISBN: 9783211996829

ISBN-10: 3211996826

ISBN-13: 9783211996829

Edition: 2010

Authors: Norbert Leitgeb

List price: $119.99

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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 place a medical device on the European market, but also informs on pitfalls and chances, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process can be implemented which comprises risk analysis, risk assessment, risk management and risk control. The book describes which safety requirements shall be met and how they can be realised and tested.

Book details

List price: $119.99
Copyright year: 2010
Publisher: Springer Wien
Publication date: 3/2/2010
Binding: Paperback
Pages: 233
Size: 6.69" wide x 9.53" long x 0.45" tall
Weight: 0.990



Preface



Medical devices



Background



What is a medical device?



Which requirements must be met?



How are medical devices placed on the market?



Hierarchy of requirements



European market approval



Medical devices differ



What is the meaning of the CE-mark?



How do devices get a CE-mark?



Administrative obligations



Organizational obligations



Legal obligations



Declaration of conformity



Confidence



Carefulness



Warranty



Product liability



Opportunities und pitfalls



How safe is safe enough?



Risk



Risk perception



Objective risk



Risk management process



Risk analysis



Risk assessment



Risk/benefit assessment



Risk monitoring



Software



Medical devices safety



Essential requirements



Fault conditions



Safety concept



Application safety



Usability



Clinical assessment



Biocompatibility



Hygiene



Environmental safety



Interference with the environment



Environmental conditions



Electric installation



Electrostatic discharges



Interference by magnetic fields



Interference by radiofrequency electromagnetic fields



Impact on the environment



Electromagnetic Emissions



Fire and explosion protection



Ecological safety



Electric safety



Biological aspects



Body resistance



Cellular excitation



Effects of electric currents



Electric current density



Limitation of Voltages



Safety voltages



Patient environment



Leakage currents



Touch current



Patient leakage current



Patient auxiliary current



Earth leakage currents



Basic assumptions in safety technology



Safety classes



Safety class I (protective earthing)



Safety class II (protective insulation)



Safety class battery devices



Electromedical devices



History of standards



General safety requirements



Device classification



Alarms



Applied part



Safety testing



Why testing?



Who is entitled to test?



Device-specific safety goals



User



Patient



Failure assessment



Documentation



Visual inspection: Open the eyes!



Instructions for use



Device markings



Device business card: Type label



External visual inspection



Internal visual inspection



Options for corrections



Measurement



Safety parameters



Function test



Abbreviations



Homepages



Literature



Figures



Tables



Subject Index