Functional and Single Fault Safety in Medical Devices

COMPLY WITH THE IEC 60601 SERIES

Under regulatory requirements, all medical electrical equipment must comply with the IEC 60601 standard series to ensure its safety. Under IEC 60601-1, the safety of medical electrical equipment covers basic safety and essential performance (EP). In this webinar, the expert will provide information on the standardization initiative for single fault safety in the IEC 60601 series.

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In this webinar, you will learn:

• IEC 60601 and Functional Safety – importance, current status, and upcoming changes
• The concept of single-fault safety/functional safety
• Functional Safety and Active Medical Devices
• How to achieve safety in medical devices - a 3-step approach
• Where failures come from: a practical example
• How medical device manufacturers can implement MDR requirements on single fault safety
• What TÜV SÜD can do during a Functional Safety Assessment    

About the speaker