The total **** of medical devices is divided into three categories, what is the difference between Class I, Class II and Class III?

Difference

1. The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on.

2. The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.

3. The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters.

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Expanded Information

Medical devices refer to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and devices used directly or indirectly in the human body. reagents and calibrators, materials, and other similar or related items, including required computer software.

The purpose is the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.

Commonly used medicines and medical devices include:

1. Home healthcare equipment: pain massage equipment, home healthcare self-testing equipment, blood pressure monitors, electronic thermometers, multifunctional therapeutic devices, laser therapeutic devices, blood glucose monitors, diabetic therapeutic devices, vision improvement equipment, sleep improvement equipment, oral hygiene and health products, and home emergency treatment products.

2. Home medical rehabilitation equipment: home cervical and lumbar traction device, traction chair, physical therapy equipment, sleep instrument, massage instrument, functional chairs, functional beds, braces, medical inflatable air mattresses; oxygen machine, decocting device, hearing aids and so on.

3. Home care equipment: home rehabilitation nursing aids, female pregnancy and infant care products, home use of gas supply and delivery equipment; oxygen cylinders, oxygen bags, home emergency medicine kit, blood pressure monitors, blood glucose meters, nursing beds.

4. Commonly used medical equipment in hospitals: trauma disposal vehicles, surgical beds, surgical lights, monitors, anesthesia machines, respiratory machines, blood cell analyzers, differentiation analyzers, enzyme markers, plate washer, urine analyzers, ultrasound (ultrasound, ultrasound, etc.), X-ray machines, magnetic *** vibration and so on.

5. New medical devices: with the development of science and technology, some institutions of science and technology is also rapidly transformed into results. Some new manufacturers produce patented products also appeared in the market. Including some home and hospital equipment. For example, medical trauma disposal vehicle.

References

/baike.baidu.com/item/%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0?timestamp=1539051657649 "target="_blank "title="Medical Devices_Baidu Encyclopedia">Medical Devices_Baidu Encyclopedia