1. The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management. Such as: surgical instruments (knives, scissors, pliers, hooks), scraping plates, medical X-rays, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
2. The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness. Such as: medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, absorbable suture, condom, etc.
3. The third category is medical devices with high risks, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. Such as implantable pacemakers, contact lenses, intraocular lenses, ultrasonic tumor focusing knives, hemodialysis devices, implant devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters and the like.
Extended data medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.
Commonly used drugs and medical devices include:
1. 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 products.
2. Household medical rehabilitation equipment: household cervical and lumbar 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.
3. Home care equipment: home rehabilitation nursing AIDS, maternal and infant care products, and home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed.
4. Medical instruments commonly used in hospitals: trauma handling vehicles, operating tables, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, enzyme-linked immunosorbent assays, washing machines, urine analyzers, ultrasonic instruments (color ultrasound, B ultrasound, etc.). ), X-ray machine, nuclear magnetic resonance, etc.
5. New medical devices: With the development of science and technology, the scientific and technological achievements of some universities are also rapidly transformed into achievements. Patented products produced by some new manufacturers have also appeared on the market. Including some equipment commonly used in families and hospitals. Such as a medical trauma treatment vehicle.
reference data
Medical devices _ Baidu Encyclopedia