Whitepaper: Safety Standards for Medical Electrical Equipment

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Medical electrical equipment is at the heart of every modern healthcare facility. The industry is highly dynamic and continues to deliver new product innovations. At the same time, manufacturers must ensure that their products meet regulatory safety requirements at all times.

Stringent regulations and demanding standards are designed to ensure patient safety when it counts. The IEC 60601-1 series of international standards is at the heart of these efforts. It forms the basis for the design, testing and use of medical electrical equipment and sets global standards for the safety of patients, healthcare professionals and operators.

In our whitepaper, we aim to give you an overview of the requirements of the standards series. Among other things, we will

  • provide an overview of the structure and scope of the series,
  • explain what is required to comply with Edition 3.2,
  • explain product testing using a specific case study,
  • and demonstrate the role of testing and certification bodies.

Our whitepaper will give you a deeper understanding of IEC 60601-1 and its importance to the industry. Discover how IEC 60601-1 can help you demonstrate corporate responsibility, improve competitiveness and drive innovation.
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