How EN-60601 Levels Affect Embedded Medical Computers

The biggest difference between a medical computer and a standard off-the-shelf consumer model is not just price and a nice white paint job - dozens of small design variations and big construction differences exist.

One of the most important differences that separate the two is the name "EN-60601," which has proven to be one of the most important safety ratings for any medical device interacting with patients. When a medical computer, tablet or other device is embedded in a healthcare device, it must first be subjected to rigorous near-patient safety testing.

But what is EN-60601-1, which devices require this rating, and why is it important?

What is EN-60601?

EN-60601 is the EU version of IEC-60601, an international electrical standard for medical devices that must work near (and sometimes attached to) the patient.

It is a standard primarily related to the electrical and electromagnetic protection built into the device. Patients must be protected from electric shock, EM radiation and other electrically charged hazards.

These standards are highly technical and specific to the exact device, which is why it is wise to familiarize yourself with the nature of the actual wording if you are an engineer or want to learn more details.

The standard outlines the manufacturing, testing, regulatory, documentation, liability, use and design features that all devices that come into close contact with patients must undergo before they can be judged safe for deployment in any healthcare environment.

Which devices use EN-60601?

The official definition of a device subject to EN-60601 is as follows: "A device that provides no more than one connection to a specific power source, is intended to diagnose, treat, or monitor a patient under medical supervision, and enables the body or."

This rating is necessary for hundreds, if not thousands, of medical devices, all of which are in close contact with patients and could cause significant harm if an electrical short or other hazard occurs. These include electrocardiograms (ECG/EKG), medical computers, infant phototherapy equipment, medical beds, X-ray equipment, ultrasound equipment, hearing instruments, radiation therapy equipment, medical laser equipment, blood pressure monitoring equipment, and more. Of course, the same is true for any healthcare equipment required for embedded computers.

Consider also how many medical devices are temporarily or permanently implanted in patients in modern medicine, which must also be considered electrically safe in the human body at all times.

Why is it so important for medical computers?

Well, for starters, the EN-60601 rating (and its international equivalent) is in place to protect patients (and clinicians) who use the device. At a time when "first do no harm" is as important as healthcare, and computers are penetrating more and more areas of medicine, it was only a matter of time before stricter safety regulations were needed.

However, the short-term need for EN-60601 ratings is that if you plan to manufacture, purchase or implement a device in any medical setting, most markets will not allow the purchase of unrated devices. Devices. So if you put a medical tablet into a physical therapy machine or even create devices for operation in a non-hospital setting such as a nursing home or home care, they must still comply with EN-60601 or IEC-60601 standards (depending on your location) without violating local laws, hospital regulations or insurance rules.

Staying Ahead of the Law

Of course, since new technologies are always emerging in the medical field (in fact, every field), EN-60601-1 regulations are often changed or adapted to accommodate new medical devices. That's why it's important for manufacturers, medical device sellers, healthcare IT managers and hospital administrators always to be aware of all new changes or addenda to the EN-60601 rating and its international versions.