Safety of Electromedical Devices

Law — Risks — Opportunities

  • Norbert Leitgeb

Table of contents

  1. Front Matter
    Pages I-XI
  2. Norbert Leitgeb
    Pages 1-38
  3. Norbert Leitgeb
    Pages 39-70
  4. Norbert Leitgeb
    Pages 71-75
  5. Norbert Leitgeb
    Pages 77-79
  6. Norbert Leitgeb
    Pages 81-82
  7. Norbert Leitgeb
    Pages 83-99
  8. Norbert Leitgeb
    Pages 101-102
  9. Norbert Leitgeb
    Pages 103-141
  10. Norbert Leitgeb
    Pages 143-161
  11. Norbert Leitgeb
    Pages 163-211
  12. Back Matter
    Pages 213-233

About this book

Introduction

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.

Keywords

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

Authors and affiliations

  • Norbert Leitgeb
    • 1
  1. 1.Institute of Health Care EngineeringGraz University of TechnologyGrazAustria

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-211-99683-6
  • Copyright Information Springer-Verlag Vienna 2010
  • Publisher Name Springer, Vienna
  • eBook Packages Engineering
  • Print ISBN 978-3-211-99682-9
  • Online ISBN 978-3-211-99683-6
  • About this book