IEC 60601-1: The Gold Standard for Medical Devices
Posted on December 1, 2021
When installing embedded computers in medical settings, there are many things to consider. Unlike an industrial location, hygiene is of utmost importance, apart from absolute adherence to safety norms.
After all, these computers are used to control lifesaving medical equipment, so any errors can be fatal. To ensure that all electronic devices – including but not limited to computers – meet these exacting requirements, a collection of standards was devised.
Why is the IEC 60601-1 Necessary?
Medical applications pose some unique challenges for embedded computers. It is not that the devices themselves use up too much processing or storage capacity. The issue is about reliability.
In an industrial setting, if a device deviates from the norm, it can just be returned and replaced. But in a field where lives are on the line, this delay can have heavy costs. This means that computers rated for medical applications must adhere to standard specifications without fail.
Even more important is the concern about quality. If a computer powering a kiosk were to break down suddenly, it would only stall business for a while. But an embedded system failing in the middle of a life-saving operation has far worse consequences.
Finally, there is the matter of electromagnetic interference. Diagnostic devices like X-ray machines can release radiation that can affect electronics. Computers used in the proximity of such diagnostic machines must be shielded to limit interference.
Regulations Included in the Standard
The IEC 60601-1 isn’t a single regulation, but rather a collection of multiple standards. Ranging from particular requirements for specific types of medical devices to general regulations that apply to everything, there is quite a bit to unpack. Here is an overview of what goes into this standard.
Specific Equipment Compatibility
The most comprehensive part of the standard is the specific requirements for each type of medical equipment. From ventilators to defibrillators, from electrocardiographs to MRI machines, there is a particular standard governing everything.
These regulations have been carefully selected to ensure maximum safety and usability of the said equipment, making it easier for technicians to install and diagnose issues. Every device used for medical purposes is covered with a particular standard, including personal devices like pacemakers.
Apart from individual requirements for each type of medical device, there are general requirements that must be met by every piece of equipment. For the most part, they are centered around preventing electromagnetic disturbances.
Medical applications use a lot of devices that generate radiation, from X-ray machines to radiotherapy. As such, it is critical for electronics used in such applications to be well shielded from radiation.
Electromagnetic interference can reduce the lifespan of a computer, or even cause technical issues. This is why embedded PCs used in hospitals and clinics have electromagnetically shielded casings, preventing their internals from getting damaged through radiation.
Environmentally Conscious Design
A relatively recent addition to the standard, this regulation seeks to limit the environmental impact of medical devices. Like all electronics, medical devices use elements that can be harmful to the environment.
Manufacturers are encouraged to design the product’s entire life cycle to be environmentally conscious. This includes using safer alternative materials when possible, apart from ensuring proper disposal of the products in a manner that does not pollute the environment.
Ensure that Your Computer Meets IEC 60601-1 Standard
If you are planning on getting an embedded computer for use in a medical facility, you must make sure that the PC meets the stringent IEC 60601-1 standard. Not only is it a legal requirement, but it also makes the application safer.
Many manufacturers balk at the extra cost and effort required, cutting corners to deliver the cheapest product. Such devices ultimately fail during use, costing much more trouble than they save by their non-compliance.
Fortunately, a supplier like Global American takes care of regulatory compliance for you. Every piece of hardware purchased from us is guaranteed to be in line with all the norms applicable to the target industry, with comprehensive testing to ensure the best performance.
And in case your particular application needs to meet some additional regulations, we can help you with that too. Our dedicated team will take the steps to obtain any required certifications on any device of your choice.