Radio Frequency (RF) & Wireless Design

Just wanted to let everyone know that for those involved in the medical device community that the IEC basic standard for medical devices is changing from 3rd edition to becoming the mandatory 4th edition at the beginning of the new year.

The major difference is the inclusion of RF emissions having defined characteristics included in specification and no longer defined as optional or open by the developer of the medical device.

This is similar to the conversion from the 2nd edition where quality (IEC 13485) and risk management (IEC 14971) were separate specifications and not tied directly to 60601-1 - when in the 3rd edition it became mandatory that they were combined and inclusive *within* 60601-1

So in the same regard where other RF emissions and immunity Electro-Magnetic Compliance (EMC) specifications were separate from the 3rd edition of 60601-1, they are not inclusive within the document as part of 60601-1-2

So for those of you who are either already involved, I'm sure that this might be an interesting new year, depending on whether you are starting new projects where it will be required. Or for those of you who are grandfathered into the 3rd edition, time to get familiar and be prepared to accept the mandate.

EMC can be very tricky for the uninitiated. There are many detailed design characteristics that MUST be resolved. These issues are much easier resolved up front and during the design process, similar to other Design-For-_________ (DFx) standards (e.g. Design-For-Test (DFT) ) when forethought and planning are involved.

EMC is NOT an afterthought and is NOT optional in any way now. It is and has been mandatory throughout the world and in every industry, however the requirements especially for medical devices has been very loosely defined in the past. The gap is now closed and it is imperative that all medical device companies take a hard and serious look at how well they are equipped (with personnel) to handle the EMC design process.

I welcome all your comments.