Medical devices face some of the most stringent regulations of any product on the market. They have to. When a patient’s life is on the line, nothing short of the best equipment is acceptable. Even minor equipment like a provider’s stethoscope has to meet strict certification standards for safety. These standards are especially high for devices that feature a computer in their design.

The universal standard for electrical medical equipment is IEC 60601. Set by the International Electrotechnical Commission, it is an internationally recognized set of regulations for medical devices. The 60601 standard itself is divided into two components: 

  • 60601-1: This standard governs protecting the user and patient from electrical shorts. It ensures the device does not accidentally shock people while in use. 
  • 60601-1-2: This standard governs electromagnetic interference. It ensures that the device will not disrupt or be disrupted by other electrical devices being used. 

Depending on the device’s purpose, it will have to meet even more regulatory standards from the International Electrotechnical Commission. National agencies like the Food and Drug Administration also have standards to meet. 

To make the process of getting their product certified easier, medical device manufacturers will often opt to include a computer or tablet that has already been medically certified rather than design a new computer from the ground up. 

What Makes a Computer Medically Certified?

A computer can be described as medically certified if it meets the IEC 60601 standard. Ideally, they will also feature design choices like a fanless heatsink for better reliability and a waterproof front, or Ingress Protection, for easier cleaning. 

Theoretically, you could use a medical computer as a simple office or home computer, and it would function perfectly fine. You just wouldn’t be taking advantage of the design features that make the computer useful in a healthcare environment. 

To summarize: 

  • Medical device: A product with one specific use case or purpose designed specifically for medical applications. An X-ray machine, for example, is only supposed to be an X-ray machine. These products undergo rigorous tests such as clinical trials, biocompatibility, and more. 
  • Medically certified computer: General purpose computers with medical grade certifications like the IEC 60601. Depending on the nation the computer is being used in, it will have further certifications that the nation requires.

Why Choose a Medically Certified Computer?

Because a medically certified computer has already met the IEC 60601 standard, manufacturers can take that testing and incorporate it into their devices. This makes it easier for the device to pass its own specific certification. 

Choosing a computer already medically certified also removes uncertainty during the design process. By selecting a computer that already exists, a device manufacturer has a baseline for things like weight, power consumption, user interface, and more. This helps reduce research and development costs and the time it takes to get the device to market. 

What Do Medical Device Manufacturers Look for in a Partner?

When choosing a medical PC to integrate into their device, a manufacturer has four major requirements that they have to consider. 

  1. Does the computer’s manufacturer have extensive experience in designing medical-grade computers that can meet the IEC 60601-1 and 60601-2 standards? It’s not enough to know how to design a computer. You also need to understand how to meet those specific requirements. Otherwise, the device will never be approved for the public. 
  2. Does the computer’s manufacturer understand how to produce the computer and do so safely and efficiently? This includes having an ISO 13485 medically certified facility. ISO 13485 sets the standards for quality management systems and ensures that the computer’s manufacturer doesn’t just make computers but that they make computers the right way. 
  3. Does the medical computer manufacturer have enough resources to support the project’s scope? This includes things like product management, engineering, and quality assurance. A device manufacturer doesn’t want to run into a situation where their partner can’t produce units fast enough or has fallen behind schedule due to supply chain issues. 
  4. Does the computer manufacturer have experience with other certification and qualification processes? Medical device verification and validation, installation qualification, operational qualification, and performance qualification are all different requirements. These standards ensure that the device is installed and performs properly, and meets the end-user’s needs. A partner that can perform these certifications in-house can further reduce time-to-market, saving the device manufacturer time and money. 

Final Thoughts

Given the cost and complexity of designing medical devices, manufacturers need to work with trusted, reliable partners. For medical PCs, this means meeting the highest possible standards for safety and reliability. Anything less is unacceptable. 

If you’re a medical device manufacturer looking for a partner to provide medically certified tablets and PCs, contact the experts at Cybernet Manufacturing. Our staff are more than happy to review our qualifications and experience as a designer and manufacturer of medical PCs. 

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