Why few (if any) medical devices comply with their EMC standard, and what can be done about it

The 3
^rd
Edition of IEC 60601-1-2 was published in 2007, and adopted by various Standards Bodies (ANSI, AAMI, CENELEC) that same year. Since then it has replaced its earlier edition 2.1 in the lists of acceptable standards for regulatory compliance of medical devices in both the European Union and the USA. This 3rd Edition requires that EMC be `Risk Managed' for safety reasons (this is called `EMC for Functional Safety' in non-medical industries). Unfortunately, this requirement is not made explicit in this standard, and as a result, almost all manufacturers, EMC test laboratories and regulatory safety assessors (such as Medical Device Directive Notified Bodies in the European Union) overlook this Risk Management requirement. So it is arguable that most, possibly all, medical devices that have been assessed as being compliant by using the 3
^rd
Edition of IEC 60601-1-2 may not in fact be compliant, and their safety may not be managed according to either the state of the art or legal requirements. This paper discusses the reasons for this situation, and proposes a quick and cost-effective way for medical devices to be made compliant with their EMC Risk Management requirements.