Medical device classification in a class of specific refers to: through routine management is sufficient to ensure its safety, effectiveness of medical devices. Such as scalpel handle and blade, scalpel, surgical scissors, hemostatic forceps, all kinds of tweezers, needles, probes, push hair needles, implantation needles, picking needles, teaching straight pointed needles, pull hooks, blade grips, anesthesia masks, anesthesia openings, illuminated suction head, acne removers, all kinds of spatula, skin inspection ruler, skin tissue drilling, openings, cotton rolls, and interventional equipment and medical polymer materials and products.
The second class of medical devices refers to its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are classified as Class II medical devices.
The third class of medical devices is implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices, such as implantable cardiac pacemakers, extracorporeal shockwave lithotripter, patient invasive monitoring system, IOLs, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgical equipment, high-frequency electrosurgical knife, microwave Therapeutic instrument, medical nuclear magnetic **** vibration imaging equipment, X-ray therapy equipment, more than 200mA X-ray machine, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, one-time-use sterile syringes, one-time-use infusion sets, transfusion apparatus, CT equipment, and so on.
Classification basis: the state of medical devices in accordance with the degree of risk to implement classification management.
Extended information:
Commonly used medicines and medical devices
Home health care equipment
Home medical rehabilitation equipment: home cervical and lumbar traction device, traction chair, physical therapy equipment, sleep instrument, massage instrument, functional chair, functional bed, support, medical inflatable air cushion; oxygen machine, decoction device, hearing aids and so on.
Home care equipment: home rehabilitation nursing aids, female pregnancy and baby care products, home use of gas supply and delivery equipment; oxygen cylinders, oxygen bags, home emergency medicine kit, blood pressure meter, blood glucose meter, nursing bed.
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
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 results. also rapidly transformed into results. Some new manufacturers produce patented products also appeared in the market, including some home and hospital equipment commonly used, such as medical trauma disposal car.
Baidu Encyclopedia-Medical Devices