For years the US Food and Drug Administration has mandated that medical devices comply with 60601 standards for near-patient safety, and while that’s great for patients, it can be a difficult or frustrating road to navigate for medical device manufacturers.  

60601-1 ratings are given to devices that pass a rigorous screening process for potentially harmful radiation. This isn’t (generally) the kind of radiation that causes you to grow a third foot, but instead things like electromagnetic interference that could harm sensitive (and life-sustaining) medical appliances.

Navigating the ins and outs of FDA compliance for medical manufacturers is no mean feat, so we’re going to break down what it all means, what you need to do to make compliance, and the shortcuts and solutions for some of the most common complications.

Obviously, these guidelines only apply to energized medical devices (ie, devices with electrical components).

Why is the FDA Involved At All? 

Contrary to popular belief, the FDA isn’t just about enforcing nutrition facts.

The FDA is primarily charged with improving and protecting the health of the public from food, drugs, alcohol, tobacco, and medical devices, just to name a few. There’s an entire branch of the FDA devoted to medical devices, medical computer systems, and electromagnetic emissions from other devices: the Center for Devices and Radiological Health, which was started in 1982 after a significant restructuring of the FDA. 

So, any medical device must pass the rigorous screening and testing outlined by the FDA and the CDRH before it can go anywhere near a clinical setting. 

Avoiding the Burden of Testing

Medical device manufacturers spend a lot of time and money on R&D, testing, and certification. This testing covers the device itself — the computer that powers the device must pass its own separate testing and certification process.  

The device manufacturer is already testing/certifying all of the other parts of the device. Having to test the computer as well doubles the length and cost of the process (if you’re lucky), and you can’t apply for an FDA 510k under the “medical device” classification without the necessary safety testing for every component in the system.

Choosing a medical computer, medical tablet, or medical monitor solves all of those problems. Since a purpose-built medical computer is already certified 60601-1, then the customer can use the medical computer manufacturer’s safety report results in their system-level certification. This frees the medical device manufacturer from having to stress about another certification.

Unfortunately, a consumer-level mini-PC, panel PC, or tablet socketed into a medical device can’t offer that same convenience. 

Technical Requirements

The first thing to be aware of is that “IEC 60601-1” is only one version of the 60601-1 standard.

Though the basic concept is the same everywhere, there are slight differences in the standards based on the laws, concerns, and regulations of different nations. These standards are most easily spotted by the small tag in front of “60601-1”, like UL (United States), EN (Europe), JIS (Japan), CAN (Canada), KS (Korea), and AS/NZ for New Zealand and Australian versions. 

More often than not, these standards involved adding more safety features (or simply acknowledging differences: the United States and Europe use differing electrical systems with vastly difference voltage thresholds). For instance, the UL code for the United States has many more provisions protecting the patient, facility, and equipment from fire hazards (which aren’t native to the original IEC standard). On the other hand, the European code (EN) is more concerned with the danger of electric shock, owing to a higher voltage being standard there (220 volts, as opposed to 110 volts in the United States). 

The long and short of it is this: learning the ins and outs of IEC-60601-1 testing is not the end of the game. Ensure that the proper testing and certification has been researched in your country as soon as possible. Of course, your own country isn’t the end of the story: what markets do you plan on selling your device too? Is your device going to be compliant with the 60601-1 variations in those markets, or is there at least an alternate model or more modular solution that can accommodate the necessary changes to fire safety, electrical systems, and the like? 

This also means that, when it comes time to find the right medical panel PC to serve as the brains and interface for a medical device, it too can operate in Europe, Australia, Canada, or wherever you need and is certified for those conditions. 

The Benefits of a Modular System

There are of course benefits to a fully integrated, closed, proprietary system: Apple’s success can attest to that. However, designing a medical device from the ground up to be modular can make 60601-1 testing and compliance much easier.

Each individual component can be chosen for their 60601-1 compliance (or at least a nearby starting point) and integrated into the entire system. A swappable power supply can be pulled out and changed quickly to fit the 60601 requirements of a different country or region, and external cases can be changed to fit the electromagnetic emissions needs of a more stringent country. 

Integrating a pre-certified medical panel computer or tablet allows the same freedom and flexibility: not only will such devices often be tested and certified in multiple markets and regions, but they can also be altered by the manufacturer to fit custom needs. These customized solutions, on a modular medical device platform, can then be installed or deployed in any regulatory environment as needed.

Seek Out the Experts

Obviously, manufacturing a medical device is an extremely complex process, and the road from inception to the market is long and winding. With the intense legislation, safety protocols, and testing required for any device to pass muster, manufacturers could use a helping hand in the form of medical monitors, panel PCs, and tablets that have already been 60601-1 certified. 

Have any questions about 60601-1 certification, in-depth technical details about 60601-1 devices, or where to find further resources? Contact Cybernet today to talk to the experts, and get help on any aspect of the process.