The medical power supply of electric medical systems must strictly meet a lot of requirements and regulations in safety, reliability, and compliance under practice. But how does a medical power supply comply with the regulations? Here tells the truth.
Risk management under regulations
Medical power adapters are not just simple electricity suppliers but the defenders that protect the life and health of the patients. Modern medical equipment and systems are facing more challenges with the techniques developed. For example, home healthcare scenarios and equipment in hospitals are becoming increasingly complex, and the complexity requires more medical power supplies.
Meanwhile, the Global regulatory bodies are adopting an increasingly stringent approach to the review of risk management (ISO 14971). That’s why, for big brands, complying with the regulations is not just for getting the certifications, but also for reducing the risk of recall and protecting the brand’s reputation
Electrical Safety and Leakage Current (60601-1)
When talking about medical power, we can’t pass IEC60601-1—the core of medical power supplies. In designing, we must realize that IEC60601-1 is not numbers or just data. It represents 2xMOPP protection: The power supply must provide isolation voltage, withstand testing of up to 4000 VAC between input and output, and guarantee a creepage distance and electrical clearance of at least 8 mm. And even if one isolation fails, the patients will not be hit by leakage current due to the protection of the other isolation. At Quankang, we obey the principle of ISO 14971 throughout the process of designing and manufacturing a medical power supply. During the conceptual design phase of the new supply model, we can collaborate with the equipment manufacturers to provide detailed insulation diagrams, key component lists, and risk assessment reports for single failure states (such as fan failure or output short circuit).
EMC and system interference
As we mentioned above, home healthcare and hospital scenarios are becoming increasingly complex, and that presents a big challenge to Electromagnetic compatibility (EMC) and interference immunity of medical power supply. There are many different kinds of Wireless signals in these places, wifi, Bluetooth, and RFID, and the precise medical equipment can’t bear even the slightest electromagnetic interference. In this situation, the medical power supplies must meet the requirement of IEC 60601-1-2, that Power supplies must not only strictly control EMI conduction and radiation to protect precision instruments, but also build robust defenses against EMS interference.
In home healthcare situations, power supplies must face the challenges from unstable AC mains power and be shared across multiple devices, which also require high quality medical power supply with outstanding EMC and immunity performance.
Applications of power protection mechanisms in medical systems
In practice, power supply compliance depends not only on IEC/EN 60601-1 or CB test certificates, but also on the actual environment in which the power supply is used. The power supplies have an ideal operation environment when testing, but the real world is out of the lab. So we added protections in medical power supplies to ensure their performance in different situations, including overvoltage protection (OVP), overcurrent protection (OCP), short-circuit protection (SCP), and overtemperature protection (OTP)：
Ⅰ.Overvoltage Protection (OVP)
When the system input voltage experiences a transient increase or fluctuation exceeding the test range, OVP promptly limits the output voltage, ensuring the safety of downstream loads and patients.
Ⅱ.Overcurrent Protection (OCP)
In the event of sudden load increases or short-term surges, OCP limits the current peak, preventing overload of the power supply or load, and maintaining the output within a safe range.
Ⅲ.Short-Circuit Protection (SCP)
If the system interface or load circuit is accidentally short-circuited, SCP immediately disconnects the output, preventing overcurrent damage to the power supply and the entire system, while also preventing excessive leakage current.
Ⅳ.Overtemperature Protection (OTP)
When cooling conditions are limited or the local temperature rise exceeds standard test conditions, OTP ensures the temperature safety of the power supply and surrounding systems by limiting the output or shutting down the power supply.
Conclusion
In medical power systems, medical power supplies should not only comply with the regulations and pass the tests but also stay stable and reliable in real medical equipment operation.
Standards and certifications set the requirements that the supplies should meet in leakage current, insulation, interfaces, and EMC (electromagnetic compatibility) aspects, as well as the risks in this system. And the protections, like OVP, OCP, are the direct response to these risks, ensuring medical power supplies to maintain performance required by regulation, even under abnormal testing situations.
In conclusion, power supply compliance is not simply proven through standard testing; it relies more on its ability to handle various deviations in real-world systems.
Understanding and properly utilizing protection mechanisms can ensure that power supplies continuously meet regulatory requirements in real-world applications, guaranteeing the overall safety of medical systems. Contact us to get professional medical power solutions.
