With the rapid development of modern medical devices and the performance of the instrument itself, more attention has been paid to the safety of the human body, such as ultrasound, life monitors and other instruments in close contact with the human body, the normal operation of medical equipment is vital, the power supply of medical equipment must comply with the relevant regulations of safety, leakage, EMI-RFI radiation, and protection to prevent patients and medical personnel from being electrocuted. Medical grade power supplies also need to meet EMC to reduce electromagnetic radiation and protect electromagnetic radiation. Therefore, for the design of medical power supplies, Mornsun pays great attention to the quality and reliability of unique medical grade power supply solutions.
Brief Introduction of Medical Grade Power Supply Standard - EN60601
With the continuous advancement of science and technology, medical devices have developed rapidly, especially electronic devices that directly contact the human body. Under the influence of the COVID-19, social aging, shortage of medical staff and other issues, cutting-edge medical devices and equipment have provided strong support in clinical applications, and power supplies have provided stable electrical energy for these medical devices and equipment. Healthcare equipment is strictly regulated by standards-based requirements and related product testing. The most important of which is IEC60601, which includes a set of requirements for electrical and electronic equipment used in healthcare. It was first released almost 40 years ago and has kept pace with changes in the industry. The 2nd edition of the standard introduced three different types of risk assessment related to sensors or pads applied to the patient, namely body (B), body floating (BF), and cardiac floating (CF). The 3rd edition introduced the concept of means of protection (MOP), for the patient - means of patient protection (MOPP) - and for the operator - means of operator protection (MOOP).
One of the key safety concerns with medical devices is that patients are often electrically connected to the device. In IEC60601, connecting
parts are defined as "applied parts" (AP) - an important definition when specifying general requirements for medical products.
According to IEC60601, medical equipment must contain at least one protective device (MOP) to ensure that both the patient (if connected
via an AP) and the operator are protected from the risk of electric shock even in the event of a fault. This can be achieved through safety
insulation, protective grounding, prescribed creepage distances, air gaps, and other protective impedances or by combining these techniques.
The standard treats operators and patients slightly differently, leading to different classifications: "means of operator protection" (MOOP) and
"means of patient protection" (MOPP). One reason for this distinction is that when an electrical fault occurs, the patient may be physically
connected through the AP and be unconscious. This means that MOPP requirements are stricter than MOOP. Each term is defined in terms
of isolation voltage, creepage distance and insulation level. When researching medical power supply requirements, the type of application
will determine if it needs to meet the requirements for means of operator protection (MOOP) or the more stringent means of patient
protection (MOPP).
MORNSUN has over 25 years of experience in delivering reliable and safe power supply solutions for medical and healthcare devices. The
design and manufacture meet the requirement of medical safety standards for a range of applications, such as medical imaging, surgical
devices, medical devices, dental equipment and health and beauty.Please visit our medical power supply modules page. Alternatively, if you
would like to discuss your power requirements in detail, feel free to get in touch with our team of technical specialists at fae801@mornsun.cn.
Requirements of Medical Grade Power Supplies Criteria
The normal operation of medical equipment is related to the health of patients, doctors, and even their lives, and the reliability of the power supply plays a key. The IEC 60601 specifications for creepage distance, clearance and leakage current criteria all need careful attention when designing an AC/DC power supply for medical applications. In general, the medical grade power supply has and is not limited to the following requirements:
1. Safety. Mainly reflected in:
(1) A sufficiently safe distance design.
For the power supply with non-solid insulation, it is necessary to ensure that the primary and secondary sides have sufficient safety distance.For example, the power supply that meets 2MOPP, the creepage distance is ≥ 8mm and the clearance is ≥ 5mm, which is more stringent than IEC62368.
(2) Weak patient leakage current of the input to the output.
But the severity of the injury varies with the location of the shock. For example, the risk of physical harm to a person is greatest when an applied part is in contact with their heart or bloodstream, so the limits are considerably lower for power supplies in parts that fall under the Type CF classification. Based on the standard, patient leakage current needs to be controlled for all the B/BF/CF type medical devices, with different leakage current allowances as shown in the below table.
(3) High withstand voltage between input and output.
Although the input and output voltages of DC/DC are low, a single fault may lead to the DC/DC power supply access to grid voltage directly. So the isolation voltage of the DC/DC power supply also needs to be evaluated according to the grid operating voltage. A sufficiently high isolation voltage can ensure the isolation strength of the primary and secondary sides of the power supply≥ 4000V to ensure the safety of the system and people.
2. Reliability.
The normal operation of medical equipment is a matter of life and death for patients and doctors, and the reliability of the power supply plays an important role in the reliability of equipment. For applications where the power supply may be exposed to vibration or contaminants, the reliability of the power supply can be improved by the isolated power supply in an encapsulated package.
3. Good protection against electromagnetic radiation.
Hospitals and clinics provide dedicated clean power sources for their most sensitive medical equipment. Issues such as electromagnetic compatibility (EMC) have become more important for home medical devices due to the popularity of wireless communication technologies. The latest version of IEC 60601-1-2 (version 4) has updated EMC test procedures and acceptance levels accordingly.
MORNSUN Intelligent Power Solutions Meet Medical Grade Power Supplies Criteria
Mornsun power supply solutions for medical devices are designed to meet the requirements associated with these applications. Our AC/DC converters and DC/DC converters for medical equipment can provide a high reliability and a high cost-effective. In terms of safety, our G_S-R2 and H_S-R2 Series certified by EN60601-1, and ANSI/AAMI ES60601-1 ((1MOPP/2MOOP), offer a current leakage lower than 2µA with isolation of 4200VAC. And an MTBF of 3500,000 hours ensures high reliability. Medical and healthcare devices also require increasingly more compact, high-efficiency, reliable, and economical power supplies. MORNSUN high-power density AC/DC switching power supplies LOF series is suitable for BF applications and conforms to the medical safety standards, including 2MOPP, and the 4th version of EMC. The LOF Series has an (85)90-264 VAC input voltage and a leakage current below 0.1mA.The selection of medical-grade ac power supplies should be cautious and truly safe and reliable. As a professional power supply provider, Mornsun is reputable, can provide proof of compliance with relevant norms and standards, and complies with quality and reliability standards to help you avoid the risk of power supplies.
Power Solution for Ventilator
Medical ventilators use positive pressure to blow oxygen or mixed gas into the patient's airway and lungs, usually consisting of a breathing tube and the ventilator itself,
and some medical ventilators are equipped with compressors, humidifiers, and heaters. Ventilator power supply plays a vital role in the function of mechanical fans and
usually obtains power from electricity or compressed gas. The Ventilator power supply can come from a 100-200VAC, 50 Hz 60 Hz wall outlet, or a 10-30VDC battery.
The power supply of a ventilator is commonly used to power ventilators for home care and transportation. Medical ventilators usually require some kind of power supply
to function properly. The ideal medical ventilator power supply is uninterrupted (that is, with some built-in redundancy) and is easy to transport. Even in large hospitals,
sometimes, the power supply is unreliable, and there are usually UPS lines in the ICU area.
Mornsun provides medical AC/DC converter power supply LH25-20B24MU, whose input voltage ranges from 85VAC to 264VAC, and has the characteristics of low
power consumption, high efficiency, high reliability, low ripple and low noise. The isolation voltage of this AC/DC converter power supply is up to 4000VAC, conforming
to lEC60601-1 exact en 60601-1 Japanese AMIES60601-1 Mae CANZAAMIES C22.2 No.60601-1 approved 2MOPP), EMI conforms to EN55011 (CISPR11) Class B
standard, is a widely used medical power supply and satisfies high-reliability AC appliances.
The medical high efficiency isolated DC/DC converter URH2424LP-20WR3 has the features of a wide input voltage range of 9-36VDC, high efficiency up to 89%, i
solation voltage up to 5000VAC, overvoltage protection (OVP) and short circuit protection (SCP), and meets the requirements of EN60601-1 dual patient protection
(2MOPP). The leakage current is less than 5µA, so it is an ideal choice for a ventilator DC/D power supply.
Application Cases
MORNSUN AC/DC Power Supplies Brochure
MORNSUN - Your Professional Power Supply Manufacturer
Technical team. Our technical engineers at MORNSUN have designed varied AC/DC power supplies catering to the various needs of your power
systems. You can choose one or more of our advanced and cost-efficient components, from board mount AC/DC converters and enclosed
switching power supplies to DIN Rail power supplies. Guided by the service principle of "trustworthy", MORNSUN offers the best products, fast
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MORNSUN provides professional power supply services. Backed by a perfect management system that consists of advanced research
technology, a high-quality raw material platform, advanced equipment, excellent manufacturing process management, specialized screening
sequence on reliability and rich experience, each solution from MORNSUN is designed to improve the stability, security, and reliability of your power
system.
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