Medical equipment generally comes into direct electrical contact with patients, e.g., electrocardiograph conductive pads, thus making electrical safety of prime concern. IEC 60601 is a standard that specifies basic requirements for medical power supplies with specific emphasis on Means of Protection (MOP) for electric shock. Protection features in this context include safety insulation, protective earth, adequate creepage distances, and reinforced layers of insulation.
The standard also differentiates between protection levels for operators and patients, which are called Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP). As the patients could be unconscious when the device is operated, 2 x MOPP classification has more stringent requirements, providing maximum isolation and protection.
Evolution of Medical Power Supplies to Meet Changing Standards
While power supplies are not themselves medical devices, their construction must be according to medical standards to achieve compliance. Power within hospitals is generally clean and stable, but home medical devices must consider electromagnetic compatibility (EMC) because they are more vulnerable to Bluetooth, Wi-Fi, and other wireless technology. The new IEC 60601 4th edition has revised EMC testing and acceptance levels accordingly. In addition, manufacturers must adhere to ISO 14971 for risk management and implement a Quality Management System (QMS) according to ISO 13485, as required by the EU Medical Device Directive. These systems ensure a harmonized assessment of risk across an entire product lifecycle.
Choosing Suitable Power Solutions
To meet IEC 60601, medical devices generally use AC/DC power supplies that are certified for medical use. Some Body Floating (BF) applications need additional measures, like the use of 2 x MOPP-rated DC/DC converters to assist in ensuring safety standards. This is especially important for medical equipment with battery backup to ensure compliance even during AC power loss. Medical equipment often requires different levels of DC voltage, and these levels can be efficiently regulated by combining IEC 60601-approved DC/DC converters with an ITE 60950-approved AC/DC power supply. When used properly, this setup achieves full compliance without the need for costly special power solutions.
Traco Power’s Commitment to Safe and Reliable Medical Power Solutions
Traco Power has come up with transformer technology that is specifically tailored to address the isolation and safety needs of the medical sector. Low coupling capacitance between transformer windings by Traco Power products reduces current transfer across isolation barriers to ensure conformity to IEC 60601. Additionally, Traco Power operates under a Quality Management System (QMS) according to ISO 13485 standards and generates risk assessment files to the standards of ISO 14971. These include comprehensive assessments of insulation integrity, operational reliability, fan failure modes, flammability hazards, and mechanical stress testing. With the availability of pre-validated risk assessment information, Traco Power helps medical device manufacturers streamline their certification procedures, thus reducing time and monetary investments.
Conclusion
With increasing development in medical technology, compliance to safety standards like IEC 60601 becomes indispensable. Through the application of medically compliant power solutions, manufacturers are able to offer device reliability, regulatory conformance, and above all, patient protection. With its technical know-how in advanced power technologies, Traco Power is still assisting the medtech industry in achieving highest performance and safety levels.
* Based on materials from Traco Power
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