IEC 60601-1-2 4th Edition

Written By: Genine Grant, Program and Quality Manager for Integrated Systems at Gilero

IEC 60601-1-2 Ed 4:2014 is now in full force. 

The initial reaction to a change in regulatory requirements, significant or otherwise, is usually “DARN IT! Just when I finally got the hang of this thing someone goes and changes it, yet again.” That’s the way of the regulatory world.

IEC 60601-1-2 4^th Edition is significantly different from its predecessor.

For those of you who managed to get your products cleared and on the market prior to the December 31, 2018 deadline AND you are only selling in the US – you’re off the hook. That is until you decide to make changes.  For the rest of us, resistance is futile.  Our quandary will be trying to figure out how to ensure compliance for a device that was not designed to handle such interferences.  In some cases, our only option may be to redesign the device.

The standard, in and of itself, is all about ensuring that basic safety and essential performance of a medical device is maintained in the presence of electromagnetic energy.  The 4^th edition incorporates new safety requirements pertaining to electromagnetic disturbances, as this was felt to be inadequate in the previous version.  It’s in the area of immunity that the breadth of changes are made.

So why the focus on immunity at this time?  Well, let’s start by clarifying what is meant by EMC immunity.  EMC immunity refers to the ability of a device – in this case a medical device – to withstand the electromagnetic energies that it comes into contact with.  In other words, it’s a measurement of a devices ability to continue performing intended functions in the presence of EM emissions given off by other sources in the environment.

Why is this so important?  It’s important because of the significant growth and proliferation of today’s technologies and their prevalence in our everyday lives.  10 to 15 years ago, for example, cell phones would be strictly prohibited in surgical theaters, and most device-centric medical treatments were administered in medical facilities.  There were tighter controls and more rigorous oversite in the environments where these devices were used and what additional equipment was allowed in the same environment.  This is not the case today and it will it be the case in the future.  Today, medical management is moving into non-traditional environments such as the home, schools, transportation vehicles, even restaurants and shopping centers.  As such, the devices used to provide/administer care will be subjected to all kinds of electromagnetic emissions.  In these environments there is little that can be done to control emissions.  It now becomes super critical that the design of medical devices take into serious consideration the environments in which they are intended to operate and that they are designed to be resilient enough to “take a beating and keep on ticking”.  Imagine the consequences of your pacemaker going on the blink because the person next to you is using their iPad to watch the latest youtube video, or if the internal clock on your automated insulin pump loses time because you went for a walk near a cell tower.

Like it or not, this is our new reality.  It is the by-product, so to speak, of the vast number of technological advances we’re seeing.  The very fact that we now have the ability to administer medically necessary therapies outside of a traditional medical setting is indicative of this reality.  It’s only fitting that the design and development of such medical devices will be held to a similarly modernized standard of regulatory scrutiny.      

As a Program Manager for medical device development and commercialization, I’m all for the new requirements of the 4^th edition.  Yes, it may impact my project schedules and budgets, but the alternative is not very appealing.  After all, it may very well be me or my loved ones who need to be treated using the very device I helped bring to market.  You better bet, I’m going to want it to work.