Medical device classification includes a brief description of the content

1, the classification of medical devices 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, hooks, blade grippers, anesthesia mask, anesthesia openers, illuminated suction head, acne removers, all kinds of spatulas, skin inspection ruler, skin tissue drilling device, openers, cotton rolls, and interventional equipment and products of medical polymer materials.

2, the second class of medical devices refers to its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.

3, Class III medical devices are implanted in the human body, used to support, maintain life, the human body is potentially dangerous, its safety and 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.

4, classification basis: the state of medical devices in accordance with the degree of risk to implement classification management.