IEC 60601-1-2 is an international standard for medical implements which, as a supplementary standard, focuses primarily on the safety aspect of the equipment and specifies requirements for electromagnetic compatibility. The standard is identical to the German DIN standard EN 60601-1-2, which was slightly modified in the third edition from 2007 and over the years.
In 2014, the fourth edition of IEC 60601-1-2 was introduced with some major changes that have not yet been implemented as a European standard. To comply with the supplementary standard, there are no prescribed evaluation criteria, which would be hardly feasible due to the variety of medical equipment with their individual characteristics and characteristics.
Manufacturers of medical devices are therefore required to specify the correct functioning of the device in question and to specify deviations and tolerances according to professional risk management in order to implement the international standard appropriately.