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Safety of Electromedical Devices Law - Risk - Opportunities

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ISBN-10: 3211996826

ISBN-13: 9783211996829

Edition: 2010

Authors: Norbert Leitgeb

List price: $109.99
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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.
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Book details

List price: $109.99
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
Language: English

Medical devices
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
Product liability
Opportunities und pitfalls
How safe is safe enough?
Risk perception
Objective risk
Risk management process
Risk analysis
Risk assessment
Risk/benefit assessment
Risk monitoring
Medical devices safety
Essential requirements
Fault conditions
Safety concept
Application safety
Clinical assessment
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
Applied part
Safety testing
Why testing?
Who is entitled to test?
Device-specific safety goals
Failure assessment
Visual inspection: Open the eyes!
Instructions for use
Device markings
Device business card: Type label
External visual inspection
Internal visual inspection
Options for corrections
Safety parameters
Function test
Subject Index