What does Medical Grade Mean for Power Supplies? | Symmetry Blog

Mar 23, 2018

What does Medical Grade Mean for Power Supplies? | Symmetry Blog


When designing electronic equipment that lives depend on, it’s crucial that the power supply is properly regulated and has reliable isolation. Continue reading to learn more about medical grade certification for medical equipment.


What does Medical Grade mean?

For electronic equipment to be approved for medical applications, they must meet IEC 60601 safety standards. IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, and the primary standard governing medical device design is IEC 60601-1. Gaining compliance with 60601 is the de facto requirement for new medical devices to reach the global market.

Designing medical grade equipment requires effective and reliable isolation between the AC input and the power supply, internal high voltage stages, and DC output. If isolation is not properly implemented, then electric shock could occur, compromising the safety of the medical device. IEC 60601 also requires sufficient spacing between the conductors and the electronic components for proper isolation. Another factor to consider for IEC 60601 certification is doubled or reinforced insulation to meet leakage requirements.

Design methodology and workflow are also part of the IEC 60601 certification process. Engineers can expect medical equipment to typically require longer design cycles compared to commercial designs, and providing greater life expectancy with more attentive support by suppliers.


Understanding Which Edition of IEC 60601 to follow

The US, Canada, and the European Union follow the 3rd edition of IEC 60601, but countries like Japan, Australia, New Zealand and China still use the 2nd edition. Some of the requirements between the two editions potentially conflict, so engineers should understand what markets they are designing for and be aware of the differences between the 2nd and 3rd editions of IEC 60601.


Medical-Grade Certified Power Converters

Due to the high-risk nature of medical applications, the corresponding electronic equipment must be held to very high standards of safety and reliability.

RECOM’s modular REM (DC/DC) and RACM (AC/DC) series converters offer complete, compliant solutions that reduce design time, simplify end-user certification and provide faster time to market. These DC/DC and AC/DC converter series feature reinforced isolation with two means of patient protection (2 x MOPP), low leakage (BF conform) and >8mm creepage and clearance distances. All medical-grade converters come fully tested and are complete drop-in products. RECOM also offers cost-effective medical DC/DC converters with reinforced isolation of up to 10kVDC suitable for high voltage applications. With its RxxPxx/R & RxxP2xx/R series RECOM also offers medical DC/DC converters with an extended reinforced isolation of up to 8kVDC suitable for high voltage applications.


Recom REM (DC/DC)


For more information about RECOM medical grade products, click here.




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