Clinicians, nurses, specialists, and other healthcare staff deal with medical issues daily. These can range from a simple cold to a life-threatening heart attack. It’s important for them to know exactly what tools are available, capabilities, and any limitations.

Computers are probably the most versatile tool they have at their disposal. They make many operations simpler, safer, and more efficient. A hospital staff can become comfortable with “their” machines, and trust them as part of the daily workflow.

So, such staff can become confused when medical equipment companies start throwing out words like “medical grade PCs,” “hospital grade computers,” and “healthcare grade machines.” They may wonder if they’ve been using their once familiar workstation on wheels wrong. Or that the medical PC in the ICU is not standard for the department. Or somehow it’s even causing harm to the patients.

We want to help you eliminate any confusion and expand on a major difference every healthcare worker needs to know.

Medical Grade Means 60601-1 Certified

Simply, there is no such thing as a hospital grade computer. Nor is there a healthcare grade PC. They’re marketing terms, with the PC usually an off-the-shelf brand with mild tweaks like an easy-to-wipe screen or casing, or built with flat angles. 

A medical grade computer is different. This is a PC that met certain standards set by the medical equipment industry. While there’s no universally agreed-upon list of those standards, the medical computer must be 60601-1 certified to be called medical grade.

A device like a medical grade tablet that’s certified as 60601-1 means it has met the highest requirements available for safety (Safety 60601-1) and electromagnetic compatibility (EMC 60601-1-2) in a medical setting. It has been tested for hazards like fire, ignition from flammable anesthetics, electrical shock, mechanical impact, excessive electrical energy output, and radiation. It won’t interfere with potentially life-sustaining or saving nearby medical devices like an anesthesia machine. 

The International Electrotechnical Commission or IEC is the standards organization responsible for the 60601-1 certification. All tests must be completed by an accredited lab. The process is costly and can take months. And once a product receives certification, it can no longer be changed. If it does, it must undergo the certification process again.

Some computers carry the labels EN60601-1, UL60601-1, and cUL60601-1. These are medical grade PCs with additional standards set by the region (Europe) or country (US, Canada).  

Finally, some computer companies will claim their PCs are “medical grade compliant” because they meet one of the two tests for 60601-1. They are still not medical grade, and could cause harm if treated like one (example: used in an operating room). Healthcare organizations should ask all vendors if their products are medical grade and to provide the necessary certifications. 

Closing Thoughts

Healthcare workers are in the business of saving lives, and must have trust in their equipment. A medical grade PC is 60601-1 certified; it has been tested to truly work within the hospital environment. Contact an expert at Cybernet if you’re interested in knowing the specifics of the standard, or features like fanless design and antimicrobial housing which are quite common on medical grade computers.

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