What is an EN-60601 Rating and How Does it Affect Embedded Medical Computers?

June 17, 2019 David Martinez, Cybernet Manufacturing

The big difference between medical computers and standard off-the-shelf consumer models isn’t just price and a nice white paint job — there are actually dozens of small design changes and large structural differences.

One of the most important distinctions separating the two is the designation “EN-60601,” which turns out to be one of the most important safety ratings for any medical device that interacts with patients. And when a medical computer, tablet or other device is being embedded in a health care device, it must first be rigorously tested for near-patient safety.

But what is EN-60601-1? What devices need that rating, and why is it important?

What is EN-60601?

EN-60601 is the European Union version of the IEC-60601, which is an international electrical standard for medical devices that must work in close proximity (and sometimes even attached) to patients.

It is a standard that related mostly to the electrical and electromagnetic protections built into the device. The patient must be shielded or safeguarded from things like electrical shocks, EM radiation, and other energized dangers.

These standards are obviously highly technical and specific to the exact devices, which is why it's wise to familiarize yourself with the nitty-gritty of the actual wording if you’re an engineer or simply wish to know more of the details.

Basically, the standard outlines the manufacturing, testing, regulations, documentation, accountability, use, and design features that all close-patient-contact devices must undergo before they can be judged safe for deployment in a medical environment of any kind.  

What Devices Use EN-60601?

The official definition of what devices are subject to EN-60601 is as follows: "equipment, provided with not more than one connection to a particular supply mains and intended to diagnose, treat, or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient."

This rating is necessary for hundreds (if not thousands) of medical devices, all of which come in close contact with patients and could present significant harm should an electrical short or other dangers occur. These include electrocardiograms (ECG/EKG), medical computers, infant phototherapy devices, medical beds, x-ray gear, ultrasound devices, hearing instruments, radiotherapy devices, medical laser devices, blood pressure monitoring equipment, and so much more. Also, of course, any health care device at all that’s required by an embedded computer.

Consider, too, how many medical devices are implanted temporarily or permanently in a patient in modern medicine that must also be judged electrically safe for literally being inside the human body at all times.

Why is it so Important for Medical Computers?

Well, to begin with, the EN-60601 rating (and its international equivalents) were put in place to protect patients (and clinicians) using the equipment. When “first do no harm” is as important as it is in health care, while simultaneously computers are penetrating more and more aspects of medicine, the need for stricter safety regulations was only a matter of time.

However, the more short-term need for an EN-60601 rating is that, if you’re planning on either manufacturing, purchasing, or implementing devices in any medical setting, most markets won’t allow for the purchase of a non-rated device. So, if you’re putting a medical tablet in a physical therapy machine, or even creating a device meant to operate in non-hospital settings like nursing homes or at-home care, they still must be EN-60601 or IEC-60601 rated (depending on your location) to not violate either local laws, hospital regulations, or insurance rules.

Keeping Ahead of the Law

Of course, since new technology is always arising in the field of medicine (and every field, really), the EN-60601-1 regulations often change or are fitted to adapt to a new type of medical device. This is why it’s always important for manufacturers, medical device sellers, health care IT managers, and hospital admin to keep abreast of all new changes or addendums to the EN-60601 rating and its international versions.

To learn more about medical computer ratings, what they are and how to implement them, or embedded medical computers, contact Cybernet today.


Author Information:

David Martinez, Technology Architect, Cybernet Manufacturing, was born and raised in Long Beach, CA, David has worked in the tech industry for most of his life. For over 15 years, he’s been a part of the Cybernet Manufacturing team. He currently serves as VP of Enterprise and OEM Accounts for the company. He enjoys connecting with people in the health care IT and industrial sectors to share ideas and discuss the latest trends impacting those industries.

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