China's "Rules for Classification of Medical Devices (Bureau Decree No. 15)" stipulates:
Article 4: The classification of medical devices should be based on the structural characteristics of the medical device, the form of use of the medical device and the use of medical devices in the three aspects of the situation of the comprehensive judgment.
The specific determination of the classification of medical devices can be based on the "Medical Device Classification Determination Table" (see Annex).
Article V Classification of medical devices based on judgment
(A) the structural characteristics of medical devices
The structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(B) the form of use of medical devices
According to the different intended purposes, medical devices are categorized into certain forms of use. Among them:
1. The use of passive devices in the form of: drug delivery and preservation devices; change blood, body fluids devices; dressings; surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection and cleaning devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices.
2. The use of active devices in the form of: energy therapy devices; diagnostic and monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
(C) the use of medical devices
According to the use of the possibility of damage to the human body, the impact of medical effects, the use of medical devices can be divided into contact or into the human body devices and non-contact human body devices, can be divided into:
1. contact or into the human body devices
(1) the time limit for use is divided into: temporary use; short-term use; long-term use. Long-term use.
(2) contact with the human body is divided into: skin or cavity; trauma or body tissue; blood circulation system or central nervous system.
(3) The degree of damage caused by the loss of control of the active device is divided into: minor injury; injury; serious injury.
2. Non-contact human devices
The impact on the medical effect, the degree of its classification: basically no effect; indirect impact; have an important impact.
Specifically, you can go to the State Drug Administration website to categorize and query the level of specific categories.
Question 2: What are the medical devices of the first class ah ...... The first class of medical devices refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices.
Including: scalpel handles and blades, dermatome knives, wart stripping knives, lancets, spatulas, shaving knives, dermatome scrapers, picking knives, sharp knives, pedicure knives, manicure knives, dissecting knives
Ordinary surgical scissors, tissue scissors, integrated tissue scissors, dismantling scissors, plaster scissors, dissecting scissors, gauze bandage scissors, educational surgical scissors
Ordinary haemostatic clippers, small-vessel hemostatic clippers, mosquito type Hemostatic forceps, tissue forceps, carbide inserted needle-holding forceps, ordinary needle-holding forceps, traumatic clamps suture removal forceps, skin rolling forceps, bullet forceps, gauze stripping forceps, sponge forceps, pawpaw forceps, dermatotube forceps, instrumentation forceps
Small blood vessel forceps, nondestructive forceps, tissue forceps, orthopedic forceps, needle-holding forceps, health care forceps (simple forceps), hair-pulling forceps, pawpaw forceps, dressing forceps, anatomical forceps, hemostatic forceps
Aneurysm needles, Probe Needle, Hair Pushing Needle, Hair Transplant Needle, Pick Needle, Teaching Straight Pointed Needle, Venous Pulling Hook, Trauma Hook, Flat Pulling Hook, Double Headed Pulling Hook, Skin Pulling Hook, Dissecting Hook
Blade Gripper, Anesthesia Mask, Anesthesia Openers, Illuminated Attractor Heads, Acne Extractors, Blackhead Acne Pressure Extractors, Dermatological Scraping Spoons, Skin Sleeve Scraping, Skin Scraping Detector, Dermatological Inspection Ruler, Skin Tissue Boring Instruments, Cottering Instruments, Cotton rolls
Question 3: How many classifications of scalpels are there? What are the surgical forceps, tweezers in the classification? (Name and purpose) ordinary large round knife, cut epidermis; ordinary small round knife, cut the peritoneum; plastic small round knife, used to make small incisions; sharp knife, open the cavity pipe; sickle-shaped knife, do tonsil surgery with. In addition stands vascular forceps (large, medium and small), forceps (toothed, toothless), tissue forceps, oval forceps, cocoa forceps, intestinal forceps, right-angle forceps and so on, there are a lot of kinds, according to the different surgery to choose the appropriate instruments, in general, vascular forceps, forceps, scissors, knives, needle holders are necessary for any one surgery.
Question 4: Name 10 medical devices Serial number
Name
Product name Examples
Category
1
Medical Suture Needle (without thread)
Medical Suture Needle (without thread)
II
2
Basic Surgical Knife
Surgical knife handles and blades, dermatome knives, wart removers, lancets, spatulas, shavers, dermatome scrapers, picking knives, sharpening knives, pedicure
knives, manicure knives, dissecting knives
Ⅰ
3
Basic surgical scissors
General surgical scissors, tissue scissors, integrated tissue scissors, suture removal scissors, plaster scissors, dissecting scissors, gauze bandage scissors, Educational surgical scissors
Ⅰ
4
Basic surgical forceps
General hemostatic forceps, small vessel hemostatic forceps, mosquito type hemostatic forceps, tissue forceps, carbide inserted needle holders, general needle holders, traumatic clamping and sewing
Removal of the forceps, skin rolling forceps, bullet forceps, gauze peeling forceps, sponge forceps, pawpaw forceps, dermatome forceps, instrumentation forceps
Ⅰ
5
Basic surgical forceps
Small vessel forceps, non-invasive forceps, tissue forceps, plastic forceps, needle-holding forceps, health care forceps (simple forceps), hair plucking forceps, pawpaw forceps, dressing forceps
, anatomical forceps, hemostatic clamps
Ⅰ
6
Basic surgical needles, hooks
Aneurysm needle
Ⅰ
7
Other basic surgical instruments
Blade gripper, illuminated suction head, acne extractor, blackhead acne presser, skin scraper, skin scraper
Ⅰ
Other basic surgical instruments
Blade gripper, illuminated suction head, acne extractor, blackhead acne presser, skin scraper, skin scraping
Skin scraper, skin scraper, skin scraping
Skin scraper, skin scraper, skin scraper, skin scraper, skin scraper, skin scraper, skin scraper, skin scraper, skin scraper Scraper, skin scraping
Measuring instrument, skin inspection ruler, skin tissue drilling device, openers, cotton rolls, reusable biopsy device, preoperative limb disinfection lifting
Lifting trolley, molding needles, Y-connector, torsion
Ⅰ
6801 Basic Surgical Instrumentation
Question 5: Class III Medical Device Product Classification is What? Class III medical devices are implanted in the human body, used to support, maintain life, potentially dangerous to the human body, overlooking the safety and effectiveness of medical devices must be strictly controlled, such as implantable cardiac pacemakers, extracorporeal shockwave lithotriptors, invasive patient monitoring systems, artificial crystals, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpels, microwave therapy equipment, medical nuclear magnetic *** vibration imaging equipment, X-ray therapy equipment, X-ray machines above 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion sets, CT equipment and so on. It is the highest level of medical devices and the medical devices that must be strictly controlled.
Question 6: How to classify medical devices The State Food and Drug Administration classified medical devices management, not classification. *** divided into three categories: Class I refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. The second category refers to, its safety, effectiveness should be controlled medical devices. Class III refers to the implantation of the human body; used to support, life-sustaining; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. The most stringent management is the third class of devices, see the following table: Classification directory Name Item Name Examples 6804 Ophthalmic Surgical Instruments Ophthalmic Surgical Other Instruments Vitrectomy Instruments 6815 Injection Puncture Instruments Injection Puncture Instruments Disposable sterile syringes and their gel plugs, disposable sterile injecting needles, disposable IV needles, disposable fiber-optic needles, intravenous retention needles, disposable dispensing injecting needles, Puncture needles 6821 Medical electronic instruments and equipment For treatment of the heart, first aid devices Implantable cardiac pacemakers, external cardiac pacemakers, cardiac defibrillators, cardiac pacemakers, internal aortic capsule counterpulsors, defibrillatory pacemakers Invasive electrophysiological instruments and innovative electrophysiological instruments Extracorporeal shockwave lithotripter, invasive patient monitoring systems, intracranial pressure monitors, invasive cardiac output meters, invasive multicontact physiological recorders, Intracardiac Hirschsprung beam electrograms, endocardial endocardial specimen mappers, invasive electronic blood pressure monitors invasive medical sensors various implanted medical sensors non-invasive monitoring devices arrhythmia analyzers and alarms, monitors with S-T segments medical *** devices cardiac workstations electrical *** devices extracorporeal counterpulsation and its auxiliary circulatory devices ballooning extracorporeal counterpulsation devices 6822 medical optical appliances, instruments and endoscopic devices implanted in the body or in prolonged contact with the body Ophthalmic Optical Apparatus Implanted in the Body or Long-term Contact with the Body Ophthalmic IOLs, Corneal Contact Lenses (Soft, Rigid, Plastic Corneal Contact Lenses) and Nursing Fluids, Intraocular Fillers (Vitreous, etc.), Visco-elastic Substances, Perfusional Fluids (Heavy Water, Silicone Oil) Cardiac and Vascular, Invasive, and Intravitreal Surgical Endoscopes Invasive Endoscopes (Laparoscopes, Arthroscopes, Nephroscopes, Pancreatoscopes, Diskoscopes, Sinusoscopes, and Biliary Tractoscopes), Cardiac and Vascular Endoscopes (cardiac endoscopes, vascular endoscopes), endoscopes for endoluminal surgery (transurethral electrodescopes, fiberoptic endoscopes for high-frequency electrodescopes and rigid tube endoscopes) electronic endoscopes for the upper gastrointestinal tract, bronchial tubes, colon, colon, pancreas, etc. Electronic endoscopes 6823 Ultrasound Instruments for Medical Purposes and Related Devices Ultrasound Surgery and Focused Therapy Devices Ultrasound Tumor Focusing Knife, Ultrasound High Intensity Focused Tumor Therapy System, Ultrasound fat emulsifier, ultrasound ophthalmic emulsification therapy instrument, ultrasound scalpel, ultrasound intravascular intervention therapy instrument, ultrasound breast thermotherapy therapy instrument color ultrasound imaging equipment and ultrasound interventional/intracavernous diagnostic equipment ultrasound three-dimensional (three-dimensional) diagnostic instrument, fully digital ultrasound instrument, ultrasound color Doppler, intravascular ultrasound diagnostic instrument, ultrasound colonoscopy (diagnostic instrument), ultrasound endoscopy Doppler, ultrasound cardiac endocardial imaging instrument, Transcranial ultrasound Doppler, ultrasound ophthalmology special diagnostic instrument, composite scanning ultrasound diagnostic instrument 6824 Medical Laser Instruments and Equipment Laser Surgical and Therapeutic Equipment Solid Laser Surgical Equipment (Nd: YAG, Ho: YAG, Er: YAG, ruby, sapphire, emerald green gemstone), Gas Laser Surgical Equipment (CO2, Gold Vapor, Excimer, Argon Ion), Class 3B and Class 4 Semiconductor Laser Therapeutic instrument, nitrogen molecule laser therapeutic instrument, ophthalmic laser photocoagulation machine, ophthalmic crystal laser emulsification equipment, laser vascular welding machine laser diagnostic instrument laser ophthalmic diagnostic instrument, ophthalmic laser scanner, interventional laser diagnostic instrument He-Ne laser intravascular irradiation therapeutic instrument, other laser source of intravascular irradiation therapeutic instrument laser surgical instruments laser microsurgical instruments, keratome laminar cutter for LASIK 6825 medical high-frequency Instruments and equipment high-frequency surgery and electrocoagulation equipment high-frequency scalpel, high-frequency tonsil scalpel, endoscopic high-frequency scalpel, posterior urethral electrolysis cutter, high-frequency ophthalmic electrocoagulant, high-frequency polyp scalpel, high-frequency nasal turbinate electrocoagulant, radiofrequency temperature-controlled thermal coagulant Microwave therapy equipment microwave scalpel, microwave oncological thermotherapy, microwave prostate therapy instrument, microwave therapy machine radiofrequency treatment device radiofrequency prostate therapy instrument, radiofrequency ablation heart therapeutic instrument, radiofrequency ablation prostate therapeutic instrument, endobiotics tumor thermotherapy system, tumor radiofrequency thermotherapy machine 6826 Physiotherapy and rehabilitation equipment hyperbaric oxygen therapy equipment air-pressurized oxygen chambers, oxygen-pressurized oxygen chambers Electrotherapy instrument in vivo low-frequency pulse therapy instrument, electrochemical cancer therapy machine spectral radiation therapy instrument photo-quantum blood therapy machine (oxygenated magnetized light) hyperbaric therapy equipment hyperbaric therapy instrument 6828 Medical magnetic **** vibration equipment medical magnetic **** vibration imaging equipment (MRI) permanent magnet type magnetic **** vibration imaging system, normal conduction type magnetic **** vibration imaging system, super ...... >>