08 Jan IEC 60601-1-2 4th Edition: Are You Ready?
The FDA graciously extended the deadline for IEC 60601-1-2:2014 (Edition 4) compliance beyond its original April 2017 due date to December 31st, 2018 to match the European Union deadline, but don’t let the later date lull you into a false sense of security; it is important to use the extra time to get compliant before the new deadline arrives.
IEC 60601-1-2 provides medical device EMC requirements, setting limits on the amount of electromagnetic radiation a medical device can produce and providing test criteria to ensure that the device continues to operate safely in the presence of external electromagnetic interference.
As many of the other standards have done (the IEC 60601-1 general standard, IEC 62366, and IEC 62304, to name a few), the new edition places additional burden on the manufacturer to take a risk-based approach to its compliance plan, and the standard now references Basic Safety and Essential Performance rather than “life-supporting” equipment[i].
With the new edition, device manufacturers must now submit detailed test plans to the test lab describing how to run the device under test through its worst-case normal use cases (those likely to produce the most radiation for emission tests and those most likely to cause a hazard for immunity tests) and the acceptance criteria for determining whether the device passed or failed.
ESD requirements have also been made more stringent. Where 6KV for contact discharge and 8KV for air discharge were sufficient in the 3rd Edition, the 4th Edition increases these to 8KV and 15KV, respectively[ii].
The new standard also introduces the concept of “expected use environments”, each having its own set of immunity levels. Most immunity levels have harsher interference levels than the 3rd Edition of the standard provided, reflecting the increased pervasive wireless interference from Wi-Fi, Bluetooth, etc., and the increased likelihood of using a wireless device, such as a cell phone or tablet, very close to the medical device. The use environments defined by the standard are:
- Professional healthcare – hospitals, doctor’s offices, nursing homes, etc.;
- Special environments – particularly EMI-hazardous locations such as power plants, and
- Home healthcare – other places patients use medical devices without supervision, including
- Homes (apartments, single-family residences, hotels, etc.),
- Workplaces (offices, stores, factories, etc.),
- Recreational areas (movie theaters, parks, restaurants, etc.), and
- Vehicles (planes, trains, automobiles, and boats)[i].
While the deadline now less than a year away, preparing the test plans and risk management documentation and performing the testing to ensure compliance takes time. Fortunately for the US market, existing devices are grandfathered in under the 3rd Edition rules, so long as the product is not changed to the point of requiring resubmission. All submissions starting January 1st, 2019—including resubmissions—will have to meet the 4th Edition criteria.
Those in Europe, Canada, and select other markets are not so lucky, as all products for sale must comply with the 4th Edition criteria immediately on January 1st, 2019, whether the design passed the 3rd Edition or not. For those manufacturers, scheduling a test lab to demonstrate compliance will be more difficult as other companies rush to get their tests done by the deadline, so don’t get caught at the last minute.
The Realtime Group has years of experience in Medical Device Product Development, QMS/Quality, Verification and Validation testing, and compliance. Contact a Realtime expert or give us a call today at 972 985-9100 and let us help you prepare your risk management documentation, test plans, and shepherd your product through IEC 60601-1-2 4th Edition testing before the deadline.
About Us:
The Realtime Group is your ISO 13485 / ISO 9001 certified development partner. We have a shared passion for time-to-market and product compliance. Visit us at www.TheRealtimeGroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!
Greg Turnipseed, Systems Engineer
References:
2 What You Need to Know: IEC 60601-1-2 4th Edition
3 Home Healthcare, IEC 60601-1-11