Question 2: Medical devices. Including those products, how many kinds of home medical devices are there? In the classification of medical devices, most of them belong to a class of medical devices. The country is relatively loose in management and the application procedures are relatively simple, so it gives people the impression of ordinary equipment, but because it is also an auxiliary means of medical treatment, it is defined as medical equipment. For example, many of the following are:
Family health care equipment pain equipment, family health care self-checking equipment, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, blood glucose meter, vision improvement equipment, sleep improvement equipment, oral hygiene products, adult family health care equipment.
Electric chair/bed for household health products; *** ; * * * sigh; * * * pillows; * * * cushion; * * * belt; qi and blood
Circulating machine; Foot bath tub; Plantar organs; Hand-held * * * device, * * * bathtub, fat belt;
Therapeutic instruments; Foot physiotherapy instrument; Weight loss belt; Car seat cushion; Kneading pad; * * * Chairman; Breast augmentation device;
Beauty equipment.
Family medical rehabilitation equipment, therapeutic instrument, Kang Kai high potential therapeutic instrument, cervical vertebra therapeutic instrument, domestic cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, functional chair, functional bed, supporter and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.
Home care equipment, home rehabilitation care auxiliary equipment, women's pregnancy and baby care products, home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box
Question 3: What are the large medical equipments? Hello, there are two kinds of large medical equipment, one is Class A and the other is Class B. The large medical equipment in Jiu Ge, Lu Yi is not bad! ! Can refer to it! ! ! The following is a detailed classification of large medical equipment A and B!
Class a:
1.x-ray positron emission computed tomography (PET-CT, including PET).
2. Gamma-ray stereotactic therapy system (gamma knife).
3. Medical electron cyclotron therapy system (MM50).
4. Proton therapy system.
5 other large medical equipment with a unit price of more than 5 million yuan.
Class b:
1.x-ray computed tomography (CT).
2. Medical magnetic resonance imaging equipment (MRI).
3. Digital subtraction angiography machine.
4. Medical electron linear accelerator.
5. Single photon emission computerized tomography device.
Color Doppler ultrasound does not belong to Class B large medical equipment.
Due to the high market value and large volume of medical equipment used in modern hospitals, there are CT, MRI, DR system, CR, power frequency X-ray machine, cart-type B-ultrasonic diagnostic instrument, extracorporeal shock wave lithotriptor, hyperbaric oxygen chamber, linear accelerator and so on.
I hope I can help you solve the problem! ! !
Question 4: What products are there in the first category of medical devices? Cotton swabs, gauze, thermometers, dental materials, computerized tomography, disposable injection needles, gauze and condoms all belong to medical devices.
Question 5: What are the medical devices and what are their functions? One category: medical devices that can ensure their safety and effectiveness through routine management. Such as most surgical instruments, stethoscopes, surgical caps, masks, medical X-rays, band-AIDS, etc.
Category II: Medical devices whose safety and effectiveness need to be controlled. Such as thermometer, sphygmomanometer, ECG diagnostic instrument, medical absorbent cotton, medical gauze, constant temperature incubator, etc.
Three categories: medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Such as implantable pacemakers, intraocular lenses, disposable sterile syringes or infusion tubes. Need to be questioned.
Question 6: What are the Class C equipments of the three types of medical instruments: 6823 medical ultrasonic instruments and related equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physiotherapy rehabilitation equipment, 6828 medical magnetic vibration equipment, 6830 medical X-ray equipment, 683 1 medical X-ray accessory equipment and components, 6832 medical high-energy X-ray equipment,
Class III 682 1 medical electronic instruments and equipment, class III 6822 medical optical instruments, instruments and endoscopic equipment (excluding contact lenses and nursing solutions), class III 6846 implant materials and artificial organs, and class III 6877 interventional equipment.
Question 7: What are the second-class medical devices? They can be judged according to the following.
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.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
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; The examination of human samples can provide information for medical or diagnostic purposes.
The state implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
Examples: cervical rongeur, cervical double joint rongeur, scoliosis correction rongeur, nucleus pulposus rongeur, lamina rongeur, elbow flat spinous process rongeur, gun rongeur, cranial nerve knife, detachable meningeal knife, cranial nerve knife, endocardial myocardial biopsy forceps, atrial side wall forceps, aortic side wall forceps, aortic blocking forceps, aortic hemostatic forceps, aortic free forceps, noninvasive pulmonary artery hemostatic forceps, etc.
Question 8: What does a class of medical devices include? The first category of medical devices refers to medical devices that are fully managed through daily management. Under normal circumstances, any external medicine does not directly contact with skin or tissue, and its structure is relatively simple, its function is relatively simple, and it is generally passive (external or internal power supply or other power supply), which has certain auxiliary or relieving symptoms or preventive effect, and the potential risk is little or no, so it can be guaranteed that its medical devices are mostly a kind of medical devices that do not need special management; Implanted in the body, in contact with blood or body fluids, with external power supply and high power, which causes trauma or radiation damage to people and plays a major role in diagnosis, treatment or other functions, most of the three types of medical devices must be operated or managed by specialized or trained personnel to ensure their safety and effectiveness, with great potential risks; The rest are basically second-class medical devices. The number of secondary instruments accounts for 60%, and the number of primary and tertiary instruments accounts for about 20% respectively. Judging from the above principles, it is close to ten. For specific product classification, please refer to the medical device classification catalogue on the website of the US Food and Drug Administration.
Question 9: What are the second-class medical devices? Class II 6866 medical polymer materials and products, class II 6865 medical suture materials and adhesives, class II 6864 medical sanitary materials and dressings, class II 6863 oral materials, class II 6858 medical cold therapy, low temperature and refrigeration equipment and appliances, class II 6857 disinfection and sterilization equipment and appliances, class II 6856 ward nursing equipment and appliances, class II 6854 operating room, emergency room and outpatient equipment and appliances. Type II 6846 implant materials and artificial organs, type II 6826 physical therapy and rehabilitation equipment, type II 6823 medical ultrasonic instruments and related equipment, type II 6822 medical optical instruments, instruments and endoscopic equipment, type II 682 1 medical electronic instruments and equipment, type II 6820 common diagnostic instruments and type II 68 15 injection puncture instruments.
Question 10: What are the details of the first, second and third types of medical devices? 5 points can be found in the Catalogue of Medical Devices, which contains almost all medical devices.