I. Introduction:
In today's society, with the continuous advancement of science and technology, more and more modern medical electronic equipment has been developed rapidly, especially electronic instruments that directly contact the human body, in addition to the increasingly high requirements on the performance of the instrument itself , The consideration of human safety is also getting more and more attention, such as: cardiac puncture monitors, maternal and child monitors, baby warmers, life monitors, ultrasound, and other instruments that are in close contact with the human body, that is, patients When using the instrument, it may not cause electric shock or any other danger to the human body because of the use of the instrument. Therefore, the performance of the power supply, which is known as the heart of electronic equipment, plays a vital role in medical electronic equipment. Medical power supplies are divided into AC / DC level power supplies and DC / DC level power supplies, of which the selection requirements for AC / DC level power supplies are higher.
Second, the choice of medical power supply:
Because the objects used by medical equipment are people, the requirements for the equipment are very high. The normal operation of medical equipment is related to the health of patients and doctors and even life, and the reliability of the power supply plays a key role in the normal operation of the equipment . Therefore, in some international standards, medical power supplies and industrial and scientific experimental power supplies are classified as ISM equipment at the same time, but in view of the strict safety requirements of medical equipment, medical power supply design has its own special specifications to support the more demanding life support This is especially true for class devices. In general, the medical grade AC / DC grade power supply has the following requirements:
1. Security
In terms of safety, it is mainly reflected in: â‘ The design requires a sufficient safety distance, generally speaking, the distance between input and output reaches more than 8mm. â‘¡The withstand voltage between input and output must withstand 4000VAC. â‘¢ The input leakage current requirement for output is very small. Under normal circumstances, the leakage current is required to be less than 200uA for a single fault. â‘£Grounding continuity (this requirement is required for CLASS I equipment). This is also very important for medical equipment. The large grounding resistance causes a potential difference in the ground potential of the equipment powered by different power supplies, which may be harmful to seriously ill patients. Therefore, the grounding continuity must also be rigorously tested. The resistance where the metal can be touched is less than 0.1 Ohm.
2. Reliability
Since the objects used by medical equipment are people, the reliability of medical equipment is higher. The normal operation of medical equipment is a matter of life and death for patients and doctors, and the power supply is the heart of electronic equipment, and its reliability plays an important role in the reliability of the equipment, which also means the reliability of the power supply The requirements are higher.
3. Environmental protection
To meet ROHS requirements. Medical equipment is a ROHS exempt product, so power supply products also need to meet ROHS requirements.
4. Requirements for electromagnetic radiation
EMI conduction and radiation meet EN55011, the limit is the same as EN55022 ITE equipment, but only the EMI report issued by the MDD (Medical Device Directive) approved testing agency is valid. It is usually required to have a 6dB margin in the design to meet the requirements in mass production, and it is easy to pass the medical system test.
5. Anti-interference ability
This is very important, to meet the requirements of electromagnetic radiation protection. Qualified medical power supplies should comply with EN60601-1-2, which must be coordinated with many EMC-related technical requirements. It should be particularly pointed out that the medical power supply must meet IEC61000-4-2 ((electrostatic protection capability, required to reach 3kV), IEC61000-4-3 (RF radiation protection capability, required to reach 3V / m), IEC61000-4-4 EFT ( Voltage transient withstand capability, required to reach 1kV), IEC61000-4-5 (commercial power surge withstand capability, required to reach 1kV and 2kV), IEC61000-3-2 (mains line harmonic requirements), and IEC61000-3-3 ( Power line flicker requirements).
6. What is the reputation of the supplier
The United States Food and Drug Administration (FDA) requires medical products to be manufactured by factories that have obtained GMP qualifications (that is, have good manufacturing practices). This is a set of quality certification system that should be required by manufacturers in addition to the traditional ISO9000 certification to prove that its quality control procedures comply with GMP regulations. Similarly, China also has strict control of medical power supply, for example, it must meet a series of requirements such as CE and UL medical certification.
It can be seen from the above that the selection of medical power supply should be cautious, and the price cannot be pursued blindly, and whether the system equipped with such a power supply is truly safe and reliable. When selecting and purchasing medical power supplies, you need to consider the risks that may arise. You must purchase from reputable manufacturers who can provide certification documents that comply with relevant specifications and standards and comply with quality and reliability standards and requirements.
Three or more recommended medical-grade AC / DC power modules:
At the end of this article, we recommend several medical power modules-Jinshengyang's LD series power modules: LD05 series and LD10 series. Jinshengyang is devoted to the development of low-power medical power supply modules, and enjoys a good reputation in the medical, industrial control, and power industries. Currently has LD05, LD10 series medical grade power supply, this series of power supply has the following characteristics:
1. Small size and high power density. Jinshengyang's LD series power supply is very small, among which: LD05 series power supply, the output rated power is 5W, the global universal voltage input, the volume is 50.08 * 25.4 * 15.16mm. LD10 series power supply, output rated power is 10W, global universal voltage input, volume is 53 * 28 * 19mm. This small volume power supply saves a lot of component space for small medical equipment and provides the possibility of miniaturization of the equipment.
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