Testing in accordance with the IEC 60601-1 series for Active Medical Devices

The new Medical Device Regulation (MDR) 2017/745 has changed the legal framework for all medical devices intended to be placed on the EU market. Medical devices must comply with the General Safety & Performance Requirements (GSPR) documented in Annex I to the MDR. Manufacturers generally apply international product standards to address these requirements. The IEC/EN 60601-1 series of standards is therefore important for the manufacturers of active medical devices and changes should be analysed carefully in order to understand the potential impact on product design.

The webinar provides insight into the actual changes to the 60601-1 series, focusing on Amendment 2 to IEC 60601-1, changes in 60601 collaterals (e.g. alarms, usability, etc.) and transition periods. Another hot topic, currently under discussion by Notified Bodies, test laboratories, standard committees and manufacturers of active medical devices is “Functional Safety”, also referred to as “single fault safety of medical electrical equipment related to essential performance”. This webinar provides the latest information on this topic, which is currently the subject of debate by the experts in the field.

Date and time: Tuesday, 3 November 2020, 6:30 pm (CET)

Your speaker: Dr. Tobias Beck, Department Manager MHS Testing


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