What are the first, second and third types of medical devices? What is the classification basis?

In the classification of medical devices, specific categories refer to medical devices whose safety and effectiveness can be ensured through routine management. Such as surgical handles and blades, scalpels, surgical scissors, hemostatic forceps, various tweezers, needles, probes, hair-pushing needles, hair-planting needles, picking needles, straight needles for teaching, retractors, knife holders, anesthesia masks, anesthesia openers, lighting aspirator heads, acne extractors, various curettes, skin inspection rulers, skin tissue drills, openers, cotton wool and medical polymer materials.

The second category of medical devices refers to medical devices whose safety and effectiveness should be controlled. Including X-ray filming machine, B-ultrasound, microscope, biochemical instrument, etc. All belong to the second category of medical devices.

The third kind of medical devices refers to the medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. Such as implantable pacemakers, extracorporeal shock wave lithotripsy, patient invasive monitoring system, intraocular lens, invasive endoscope, ultrasonic scalpel, color ultrasonic imaging equipment, laser surgery equipment, high-frequency electrotome, microwave therapeutic apparatus, medical magnetic resonance imaging equipment, X-ray therapy equipment, X-ray machines with a capacity of more than 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valve, artificial kidney, etc.

Classification basis: the state implements classified management of medical devices according to the degree of risk.

Extended data:

Commonly used drugs and medical devices

Family health care equipment: pain massage equipment, self-inspection equipment for family health care, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene products and family first aid supplies; Family health massage products; Therapeutic instruments; ; Weight loss belt; Car seat cushion; Kneading pad; Breast augmentation device; Beauty massager.

Family medical rehabilitation equipment: domestic cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, massager, functional chair, functional bed, supporter and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.

Home care equipment: home rehabilitation nursing AIDS, women's pregnant and baby care products, and home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed.

Commonly used medical instruments in hospitals: trauma treatment vehicles, operating tables, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, enzyme-labeled instruments, cleaning machines, urine analyzers, ultrasonic instruments (color ultrasound, B ultrasound, etc. ), X-ray machine, nuclear magnetic resonance, etc.

New medical equipment

With the development of science and technology, the scientific and technological achievements of some colleges and universities are also rapidly transformed into achievements. There are also some patented products produced by new manufacturers in the market, including some commonly used equipment in families and hospitals, such as medical trauma disposal vehicles.

Baidu encyclopedia-medical equipment