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MEDICAL GRADE VS HOSPITAL GRADE. WHAT'S THE DIFFERENCE?

Certifications matter in medicine

Clinicians, nurses, specialists, and other healthcare staff deal with medical issues daily. It’s important for them to know exactly what tools are available, capabilities, and any limitations.

So it’s easy for them to 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 but maybe 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

There is no such thing as a hospital grade computer. Nor is there a healthcare grade PC. They usually refer to a PC 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. That standard is 60601-1. To be called a “medical grade” computer, it must present certification.

The International Electrotechnical Commission or IEC is the standards organization responsible for the 60601-1 certification. An accredited lab does the testing, a long and costly process.

The computer is examined to see if it will:

Cause fire

Ignite from flammable anesthetics

Cause electrical shocks

Be affected from mechanical impact like blows or being dropped

Suffers excessive electrical energy output

Releases radiation

Other tests make sure it won’t interfere with potentially life-sustaining or saving nearby medical devices like an anesthesia machine.

Once a computer receives 60601-1 certification, it can call itself medical grade. Unless the manufacturer changes its specifications. If that happens, the revised PC must undergo the entire certification process again.

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

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

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 an antimicrobial casing which are quite common on medical grade computers.

MEDICAL GRADE VS HOSPITAL GRADE. WHAT'S THE DIFFERENCE?

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