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Committed to the development of medical devices in China
09
2024
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10
Common classification methods for medical devices
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What are the classifications of medical devices? How are they classified? I believe everyone has noticed that when going to hospitals or other examination institutions, it is no longer just about simple equipment checks as in the past; there are many advanced instruments, and the types of instruments are very diverse. This indicates that with the improvement of technological levels, the variety of medical devices has increased, and the level of medical care is also improving. To better ensure people's medical safety, the National Medical Products Administration has made some classifications of medical devices, but there are different classifications based on different uses.
Functional classification of medical devices
1. Diagnostic: Physical diagnostic instruments (thermometers, blood pressure monitors, microscopes, audiometers, various physiological recorders, etc.), imaging types (X-ray machines, CT scans, magnetic resonance imaging, ultrasound, etc.), analytical instruments (various types of counters, biochemical, immunoassay instruments, etc.), electrophysiological types (such as electrocardiograms, electroencephalograms, electromyograms, etc.);
2. Therapeutic: General surgical instruments, photonic surgical instruments (fiber endoscopes, laser treatment machines, etc.), auxiliary surgical instruments (such as various anesthesia machines, ventilators, extracorporeal circulation, etc.), radiation therapy machines (such as deep X-ray therapy machines, cobalt-60 therapy machines, accelerators, gamma knives, various isotope therapy devices, etc.), other types: microwave, hyperbaric oxygen.
Classification by device level
Class I: Medical devices whose safety and effectiveness can be ensured through routine management;
Class II: Medical devices whose safety and effectiveness should be controlled;
Class III: Implanted in the human body; used to support or sustain life; medical devices that pose potential risks to the human body and whose safety and effectiveness must be strictly controlled.
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