If you read that title, you at least know that 60601-1 is an international standard for medical grade devices that specifically relates to patient safety. Obviously that is a very vague definition, and the purpose of this blog is to block out the white noise and provide a clear understanding of what 60601-1 certification means, why it’s important, and how to distinguish different classifications from one another.

Patient Safety Comes First

We can all agree that when it comes to advancements in medical technology, we are lucky to live in a world where non-invasive diagnostic and monitoring instruments are available. However, as with all progress, there is also new risk to patients from these devices. In order to create a standard, the International Electrotechnical Commission (IEC) began publishing requirements that medical electrical equipment must adhere to in order to be certified as safe for near patient use.

These standards are updated periodically, and in most countries, gaining IEC 60601-1 is a requirement for the commercialization of any electrical medical equipment. This can be anything from a respiratory monitor to the medical computer that is running said monitor. In the United States, the FDA further requires evidence of the effectiveness of a device before it can be brought to market.

Why Does this Matter

Imagine your last visit to the doctor. You might have had an x-ray or an MRI done to help diagnose a condition. Ultrasounds are done every day to check on the health of pregnant women and their children. The importance of 60601-1 certification is obvious for medical device manufacturers. Their devices are brought in direct contact with patients thousands of times per day, and thus must be certified at every level – including the computers that they use to run their devices.

What about hospitals and healthcare facilities? Computers are an important part of healthcare administration, but they aren’t required to be 60601-1 certified. That said, there are still several instances where having that certification isn’t just better for the patient, it is better for processes. An operating room is a great example. This is where patients are the most vulnerable. We have heard stories of anesthesiologists having to sit outside of the operating room during surgery because the computers they use to administer and monitor anesthesia aren’t certified to be in the operating room. We’ve also heard of hospitals sticking with antiquated paper processes in the OR so their anesthesiologists can be in the room during surgery. Both issues are immediately solved with a 60601-1 certified medical computer.

Think of all the other times in a hospital setting where a patient is in close contact with a computer. Medical cart computers being wheeled room to room by nurses during rounds will come in close contact with patients dozens of times per day. Monitoring devices in patient rooms need to be certified. Even patient infotainment systems that are run on computers and tablets should be 60601-1 certified if they are going to be in close contact with a patient.

Alphabet Soup – IEC vs. EN vs. UL

Now that you understand what 60601-1 is, we’re going to confuse you again. But just for a minute. You have probably seen letter designations preceding the 60601-1 certifications. IEC 60601-1, EN 60601-1 and UL 60601-1 are likely the most common variations. So what do these mean?

We’ve already mentioned the IEC. They set the international standards. Anytime you see IEC 60601-1 it means that device has met the global safety standard for near patient use. There are times when different countries have their own specific requirements, which is where the other designations come from.

UL 60601-1 specifically references the United States and their requirements.  EN 60601-1 is a specific reference to European standards, which are nearly identical to the IEC standard. It is also important to note that a device can’t be certified in the United States (UL) without also meeting the international standard (IEC). Even though a manufacturer would need to apply for all 3 certifications separately, in its simplest form, if a device is UL 60601-1 certified, then it is also EN and IEC certified. If a device is EN 60601-1 certified for Europe, then it is also certified by the global IEC standard.

IEC 60601-1-X – The Last Layer

We now all know what 60601-1 is and why it is important for both medical device manufacturers and healthcare facilities to choose medical grade computers that meet these standards. We’ve covered the different acronym designations and what they mean as well. In some instances you might encounter a device that is labeled IEC 60601-1-2 or some iteration therein. What does the last digit mean in these cases?

These extra numbers refer to collateral and particular standards, often times in reference to very specific types of devices. There are currently 68 of these extra designations. We won’t get into all of them in this blog, but you can find a list of them here. There is one designation that at a base level deviates from the standard 60601-1. This designation is 60601-1-2.

60601-1-2 – Devices with this certification meet the standards for electromagnetic emissions. Essentially this means that devices won’t interfere with other electric devices. When you turn on a computer, 60601-1-2 certification means that the computer won’t cause the heart monitor in the room to shut off or malfunction.

 

We hope that this blog helped answer some of the most common questions that people have regarding 60601-1 certification. There is a lot to digest, but it ultimately all boils down to patient safety. For more information about 60601-1 safety standards or how Cybernet’s certified medical computers can fit into your next project you can contact us here.

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