Medical devices are generally divided into three categories. What are the differences between Category 1, Category 2 and Category 3?

Differences

1. The first category is medical devices with low risk, and routine management can ensure their safety and effectiveness. Such as: surgical instruments (knives, scissors, pliers, tweezers, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.

2. The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness. Such as: medical suture needles, blood pressure monitors, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, condoms, etc.

3. The third category is medical devices that have higher risks and require special measures to be strictly controlled and managed to ensure their safety and effectiveness. Such as: implantable pacemaker, contact lens, intraocular lens, ultrasonic tumor focusing knife, hemodialysis device, implant equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, blood vessels Inner catheter, etc.

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Medical devices are those used directly or indirectly Human body instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including required computer software.

The purpose is diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or functional compensation of injury; examination, replacement, regulation or support of physiological structure or physiological process; life To support or maintain; to control pregnancy; to provide information for medical or diagnostic purposes by examining samples from the human body.

Commonly used drugs and medical equipment include:

1. Home health care equipment: pain massage equipment, home health care self-test equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic devices, lasers Treatment devices, blood glucose meters, diabetes treatment devices, vision improvement equipment, sleep improvement equipment, oral hygiene products, and home emergency treatment products.

2. Home medical rehabilitation equipment: home cervical and lumbar traction devices, traction chairs, physiotherapy equipment, sleep instruments, massagers, functional chairs, functional beds, supports, medical inflatable air cushions; oxygen concentrators, frying machines Medicine devices, hearing aids, etc.

3. Home care equipment: home rehabilitation care auxiliary devices, women's pregnancy and baby care products, home feeding and gas delivery equipment; oxygen bottles, oxygen bags, home first aid kits, blood pressure monitors, blood glucose meters, Nursing bed.

4. Commonly used medical equipment in hospitals: trauma treatment vehicles, operating beds, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, microplate readers, plate washers, Urine analyzer, ultrasound machine (color ultrasound, B-ultrasound, etc.), X-ray machine, MRI, etc.

5. New medical devices: With the development of science and technology, the scientific and technological achievements of some colleges and universities are also rapidly transformed into results. Patented products produced by some new manufacturers have also appeared on the market. Includes some equipment commonly used in homes and hospitals. For example, medical trauma treatment vehicles, etc.

Reference materials

/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