Navigating FDA 60601-1 Compliance For Medical Devices

Learn the ins and outs of FDA compliance and what manufacturers need to meet 60601-1 certification.

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 screening process for potentially harmful radiation 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 and what you need to do to make compliance.

Why is the FDA Involved At All?

The FDA is primarily charged with improving and protecting the health of the public from food, drugs, alcohol, tobacco, and medical devices. In fact, there’s an entire branch of the FDA devoted to medical devices called the Center for Devices and Radiological Health, which was started in 1982.

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.

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.

Choosing a medical computer, tablet, or monitor solves all of those problems. Since a purpose-built medical computer is already 60601-1 certified , customers can use the computer manufacturer’s safety report results in their system-level certification.

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

Technical Requirements

“IEC 60601-1” is only one version of the 60601-1 standard.

Though the basic concept is the same everywhere, there are differences in the standards based on the laws and regulations of different nations. These standards are 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 involve adding more safety features. For instance, the UL code has many more provisions protecting the patient, facility, and equipment from fire hazards. On the other hand, the European code 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 US).

Ensure that the proper testing and certification has been researched in your country. Of course, you’ll also want to plan for the certification standards of the markets you plan on selling your device to.

This means you’ll also want to find a medical panel PC (the brains for a medical device) that operates and meets the market conditions of wherever it is being sold to.

The Benefits of a Modular System

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 and integrated into the system. A swappable power supply can be pulled out and changed quickly to meet 60601 requirements of a different 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, but they can also be altered by the manufacturer to fit custom needs.

Seek Out the Experts

With the intense legislation, safety protocols, and testing required for any device to pass 60601-1 certification, manufacturers could use a helping hand in the form of medical monitors, panel PCs, and tablets that have already been certified.

Have any questions about 60601-1 certification? Contact Cybernet today to talk to the experts.