At first glance, you might think commercial and medical-grade power supplies are not significantly different. However, depending on the manufacturer, commercial power supplies can vary widely from their medical-grade counterparts in terms of safety, life expectancy, and healthcare-specific features.
Similarities Between Commercial and Medical-Grade Power Supplies
The core function of all power supplies is the same – provide enough power to allow a device to operate as needed. This can be achieved through switching power supplies and utilizing transistors and capacitors for efficient conversion. These features enable compact designs that can handle wider ranges of voltages, making them ideal for medical devices of varying sizes.
What Sets Medical-Grade Power Supplies Apart? Regulatory Standards
Because medical equipment operates in critical environments, where power supply malfunctions or outages could endanger patients or interrupt life-saving procedures, medical-grade power supplies are subject to stricter regulations. Safety and regulatory standards are one major difference between commercial and medical-grade PSUs.
IEC 60601 includes standards for medical electrical systems and equipment that ensure basic performance and safety measures are in place for devices that come in contact with medical professionals and patients. Medical devices have leakage current limitations, patient contact safeguards, electromagnetic interference (EMI) reduction, and reliability standards.
- Leakage current limitations: To operate safely in medical devices, power supplies need to limit current that might leak between the input and the output, minimizing the risk of electric shock.
- Patient contact safeguards: To prevent accidental contact with voltages that would be hazardous to patients and operators, medical devices need to have extra insulation and design elements.
- EMI reduction: Electromagnetic interference can interrupt other sensitive medical devices, so equipment needs to be able to operate while handling a certain level of interference and limiting the output of EMI.
- Reliability: Medical-grade power supplies need to have longer MTBF (mean time between failures) numbers, strong voltage regulation, and good redundancy features. They should also have guarantees for longer lifespans compared to commercial-grade power supplies, enabling hospitals to use the same equipment often and for extended periods. Most commercial power supplies last about 3-5 years, but medical power supplies need to work for 10 years or longer.
- Product Lifetime: Going through the approval process to bring a medical device to market takes a lot of time and resources. Manufacturers that change components may need to go through the process again, and that includes making changes to power supplies. Commercial PSU manufacturers may not make power supplies that last the lifetime of your device, but as a medical-grade power supply manufacturer, RAM Technologies will produce our models for the lifecycle of your product.
It’s tempting to consider commercial power supplies for your medical device because they are generally more affordable. However, the upfront affordability can be quickly replaced by additional expenses associated with getting the medical device up to certain country standards. For example, the FDA requires that all components of a medical device are compliant to regulations like IEC 60601, meaning that power supplies also have to live up to these standards. For medical equipment, a medical-grade power supply is a faster and more reliable option in almost all circumstances.
By understanding the distinctions between commercial and medical-grade power supplies, you can make informed decisions to keep your electronics running smoothly and safely in critical medical settings. If you have questions about our medical-grade PSUs and what options may work for your device, contact us today.
RAM Technologies’ power supplies are 60601-1 3.2 certified. When you’re designing your medical device and need help with a PSU, contact us for details.
More Resources:
Trends in FDA-Authorized AI/ML Devices
Medical Versus Commercial Power Supplies
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