Safety of Electromedical Devices

1. Front Matter

   Pages I-XI

   PDF

2. Medical devices

   • Norbert Leitgeb

   Pages 1-38

3. How safe is safe enough?

   • Norbert Leitgeb

   Pages 39-70

4. Application safety

   • Norbert Leitgeb

   Pages 71-75

5. Biocompatibility

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   Pages 77-79

6. Hygiene

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   Pages 81-82

7. Environmental safety

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   Pages 83-99

8. Ecological safety

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   Pages 101-102

9. Electric safety

   • Norbert Leitgeb

   Pages 103-141

10. Electromedical devices

    • Norbert Leitgeb

    Pages 143-161

11. Safety testing

    • Norbert Leitgeb

    Pages 163-211

12. Back Matter

    Pages 213-233

    PDF

Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

• Europe
• control
• design
• electromedical devices
• environment
• hygiene
• iron
• management
• medical devices
• risk
• risk analysis
• risk assessment
• risk management
• safety
• testing

• Institute of Health Care Engineering, Graz University of Technology, Graz, Austria

  Norbert Leitgeb

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