免于进行临床试验的第三类医疗器械目录_EN.doc

Appendix Product Catalog for Class III Medical Device Exempted from Clinical TestingNo. Product NameCategory CodeProduct Description 1Puncture needle6815It is composed of the puncture needle tubing and tubing base. Seldinger technique is adopted to establish a percutaneous access for the endovascular devices. Seldinger technique is often referred to vascular puncture in digital subtraction angiography. 2Guide sleeve6815It is composed of catheter and catheter base (optional). Seldinger technique is adopted to establish a percutaneous access for the endovascular devices. Seldinger technique is often referred to vascular puncture in digital subtraction angiography.3Disposable sterile hypodermic needle6815The performance, structure, composition, purpose and etc are entirely covered by GB 15811 Disposable Sterile Hypodermic Needle, the product is composed of needle base, junction, needle tubing and protection cap, it is used for intracutaneous, subcutaneous, intramuscular, intravenous injections in the human body or to draw fluid drugs. If the product contains any special function or structure (e.g. self destruction, prick proof etc), then it shall not be exempted from clinical testing. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.4Disposable sterilized syringe6815The performance, structure, composition, purpose and etc are entirely covered by the GB 15810 Disposable Sterile Syringe, the product is composed of syringe sleeve, plunger, sealing ring, core cylinder, the push end and the cone end, it is used for drawing liquid or injections by hand right after drawing liquid. If the product contains any special function or structure (e.g. self destruction, prick proof etc), then it shall not be exempted from clinical testing. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.5Disposable intravenous needle6815The performance, structure, composition, purpose and etc are entirely covered by the GB 18671 Disposable Intravenous Needle, the product is composed of needle tubing (nominal outer diameter 0.36-1.2mm), needle handle, flexible tube, connector base and protective cap; it is used with the infusion apparatus or blood transfusion apparatus to establish the peripheral venous access. If the product contains any special function or structure (e.g. self destruction, filtering, prick proof etc), or new material (other than the main material, additives such as light resistant reagent or plasticizers are also included) then it shall not be exempted from clinical testing. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.6Disposable biopsy needle6815The composition is limited to biopsy needle that include puncture needle and core needle only; the materials shall meet the requirements of GB18457, it is used to obtain pathological tissues through direct puncture into human tissues or organs. The product does not include biopsy needle used with endoscopy system, vacuum constriction device, or where guidance by ultrasonic wave, X ray or other imaging device is required. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.7Disposable intravenous blood lancet6815The product is generally composed of tube plug puncture needle, protective cap, catheter, and blood lancet; it is used with disposable intravenous blood sampling containers for sampling blood from human veins. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.8Disposable anesthesia puncture needle6815The performance, structure, composition, purpose and etc are entirely covered by the YY 0321.2 Disposable Anesthesia Puncture Needle. The product is generally composed of the core base, needle base, needle tubing and core, to be used for puncturing and injection of drugs during anesthesia procedures. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.9Disposable vein indwelling needle6815The performance, structure, composition, purpose and etc are entirely covered by the industrial standard Disposable Vein Indwelling Needle to be issued soon. The product is mainly composed of the catheter assembly and the needle tubing assembly. The catheter assembly is composed of the catheter, catheter base, extension tube (if any) and any integrated junctions, the needle tubing assembly is an assembly composed of the needle tubing and needle base and/or other integrated accessories. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.10Disposable thoracentesis needle6815The composition is limited to thoracentesis needle made of needle tubing, needle base, and connection tube only; it is used for thoracentesis puncturing in the human body. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.11Disposable abdominocentesis needle6815This composition is limited to abdominocentesis needle made of needle tubing, needle base, and connection tube only; it is used for abdominocentesis puncturing in the human body. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.12Disposable artery and vein puncture needle/set (internal fistula needle)6815The product is mainly composed of the protection cap, blood lancet, needle handle, clamping, blood collection tube, female cone joint, and protection cap of the joint. It is used for blood vessel puncturing in clinical hemodialysis. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.13Disposable breast localization wire and guide needle6815The performance, structure, composition, purpose and etc are entirely covered by the YY/T 0880 Disposable Breast Localization Wire and Guide Needle; the tubing for the guide needle should be made of materials specified in GB 18457; the localization wire should be made with stainless steel or other metal alloy materials. The product is used clinically to help surgical removal of small local mammary focuses, the breast localization wire and the guide needle are used under X ray or ultrasonic waves to locate the focus and provide guidance to the surgeons so as to reduce surgical cutting and damage. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function.14Electronic upper gastrointestinal endoscopy6822Electronic upper gastrointestinal endoscopy is a type of flexible electronic endoscopy, it is mainly composed of the head end, the flexible part, the inserting part and the part connected to electrics and light source. The CCD at the head end transforms received optical signals into electric signals to be observed on the monitor through a video system. Video monitor is used to provide images for the observation, diagnosis and filming of the upper gastrointestinal tract (excluding the duodenum). 15Rigid optical laparoscope6822Rigid optical laparoscope is mainly composed of optical imaging system and lighting system. The optical imaging system includes three major systems: objective lens system, relay system and the eye lens system. The lighting system is generally made of optical fiber. The inverted image of the observed subject formed through the objective lens is transmitted through the relay system, forms the erecting image and transmitted to the eye lens, and then magnified by the eye lens or filming system for observation. It is used for observation in minimally invasive abdominal surgery. 16High frequency endoscopy surgical device6822High frequency electrode for performing surgical operation under endoscopy, it forms the application part of high frequency surgical devices. During surgeries performed under endoscopy, the device enters the human body through endoscopy access or access of other devices, to perform regular incision and coagulation on human tissue during endoscopy surgery. 17Ultrasonic wave pulse echo device for ophthalmology6823Including type A ultrasonic, type B ultrasonic and type A/B ultrasonic for ophthalmology, the product is composed of the main unit and probe, the probe generally has a nominal frequency of above 10MHz. It uses the principles of ultrasonic pulse echo to perform ophthalmology diagnosis information collecting, display and measurement. Ultrasonic diagnosis device dedicated for ophthalmology, the product is capable of ultrasonic imaging of the eyeballs, eye socket, measure the thickness of cornea, the length of axis oculi etc. 18High frequency surgical device6825It generally contains the main unit of high frequency generator and other accessories (pedal switch, surgical electrode, neutral electrode etc); high frequency currency (range of frequency 200k5MHz) flows through the human body and generate heat; the product is used for regular incision and coagulation to human tissues. The range of frequency of the high frequency generator is limited to the range 200k5MHz as stipulated in GB 9706.4, the product is only applicable to regular tissue incision and coagulation surgeries (general surgery, E.N.T, Neurosurgery, Gynecology, Laparoscopic Surgery etc). If the product present special clinical applications or operating methods, then it doesnt recommend the exemption of clinical testing, e.g. plasma cutting and coagulation under normal saline environment etc. 19Argon controller6825It includes the controller and accessories such as the argon spray; the pressure reducing valve and argon control module is used to transform the high pressure argon in the high purity argon bottle into adjustable low flow argon required for operation; when used with high frequency scalpel, it becomes the argon scalpel; and when used in conjunction with high frequency electric scalpel the product can achieve coagulation under argon environment in electrosurgery. 20Needle electrode used in radiofrequency ablation6825Needle electrode used in radiofrequency ablation is usually used with puncture needle, sleeve etc, it is an application part of radiofrequency ablation device. The ablation needle contains a temperature sensor to transfer high frequency current generated by the RF generator to specified human tissues, therefore achieving tissue ablation/coagulation/necrosis; it can be used in conjunction with RF generator (RF controller) for human tissue ablation. 21Air pressurized chamber6826It is generally composed of the chamber unit (casing, cabin door, observation window, safety valve etc), air supply and discharge system, oxygen supply and discharge system, air conditioning system, electric system, water spray system, and control panel. The pressurizing agent is air; the maximum working pressure is no higher than 0.3MPa for oxygen chamber. The product is categorized into single user oxygen chambers and multi-user chambers. Patient is exposed to an environment of high-pressure oxygen to breathe in high-pressure oxygen to heal diseases. For use by adult patients that require supplementary oxygen supply for treatment by prescription, and supplementary treatment for ischemia or oxygen deficient disease. 22Pressurized oxygen chamber6826It is generally composed of the chamber, air supply and discharge system, oxygen supply and discharge system, air conditioning system, and control system. The pressurizing agent is medical oxygen; the maximum working pressure is no higher than 0.2MPa for oxygen chamber. The product is for single user only. It is for use by adult patients that require high concentration of supplementary oxygen supply for treatment by prescription, for supplementary treatment for ischemia or oxygen deficient disease. Patient is exposed to high-pressure oxygen environment to breathe in high-pressure oxygen to heal diseases. For use by adult patients that require supplementary oxygen supply for treatment by prescription, and supplementary treatment for ischemia or oxygen deficient disease.23Automatic immunity analyzer6840It is generally composed of the sampling center, processing center, waste fluid and supply center, system control center, etc; the product is based on immunology reactions of antigen-antibody interactions, using enzyme marking or chemical luminescence reagent to mark the antigen-antibody. Through a series of cascade amplification reactions, the product establish connections between the light or electric signals and the concentration of analyzed substances, to analyze the antigen or antibody to be measured in the human sample. Quantitative, semi-quantitative or qualitative measurement are also performed on analytes in the human body fluid such as tumor markers, pathogen, antigen or antibody etc. 24Mycobacterium tuberculosis analyzer (automatic mycobacterium cultivation and monitor) 6840It is generally composed of a fixed barcode scanning system, graphic interactive LCD display, testing box, built-in system calibration tube, software and computer. Microorganism growth is monitored by observing CO2 or O2 generated during metabolism of microorganisms. Gas changes may cause changes in the reflected light or trigger fluorescent in the sensor, which in turn is captured and read by the photoelectric detector to analyze the growth of mycobacterium tuberculosis. The product is used in the detection and drug sensitivity test of mycobacterium tuberculosis. 25Automatic medical PCR analysis system6840It is generally composed of PCR system, fluorescent detection system and software; the PCR system mainly includes the temperature control unit; the fluorescent detection system mainly includes the excitation light source and detector, based on polymerase chain reactions to synthesis and amplify specific genes; the linear relationship between the cycle times (Ct value) for the fluorescent signal in the reaction tube to achieve a preset threshold and the logarithm of the initial copy number of the template is used to measure fluorescent signal through the fluorescent detection system, and analyze the genes to be measured in the human samples. The product is used to perform qualitative or quantitative detection to various analytes such as pathogen nucleic acid, oncogene, human heredity genes etc in the human body fluid. 26Surgical herniorrhaphy patch6846It doesnt include the product to be eventually absorbed. It is a flat patch or a mesh plug folded by the flat patch to be implanted in the human body, generally made of polypropylene or polyethylene glycol terephthalate materials, part of the materials may be absorbable. It functions to fill up the damaged tissue or act as a bridge. The product is used to patch up hernia outside the abdominal cavity. 27Urinary incontinence suspension6846Belt-like item to be implanted in the human body, the product is generally made of polypropylene materials; part of the materials may be absorbable. It functions as a support to the urinary tract once implanted near the urinary tract. It is used to treat stress urinary incontinence caused by excessive urinary tract movement and/or sphincter of Oddi dysfunction in women. 28Metal bone nail (non-locking) 6846See YY 0018 for structure of the product type, it is made of stainless steel and titanium alloy materials that meet GB 4234, GB/T 13810, ISO 5832-1, ISO 5832-3 standard requirements; the product is processed through regular machining, heat treatment and surface treatment (not including innovative processes such as 3D printing). The product is used for internal fixation in limb bone fracture. 29Hollow bone nail (non-locking)6846The product is made of stainless steel and titanium alloy materials that meet GB 4234, GB/T 13810, ISO 5832-1, ISO 5832-3 standard requirements; the product is processed through regular machining, heat treatment and surface treatment (not including innovative processes such as 3D printing). The product may be used independently for internal fixation in limb bone fracture.30Flexible metal wire6846See YY/T 0816 for structure of the product type, it is made of stainless steel, pure titanium and high nitrogen stainless steel materials that meet YY 0605.9, ISO 5832-1, ISO 5832-2 standard requirements; the product is processed through regular machining and heat treatment (not including innovative processes such as 3D printing). The product is used for internal fixation and strapping in limb bone fracture.31Metal cable and rope6846See YY/T 0812 for structure of this product, it is made of stainless steel, pure titanium and titanium alloy materials that meet GB/T 13810, ISO 5832-1, ISO 5832-2, ISO 5832-3, ISO 5832-11 standard requirements; the product is processed through regular machining and heat treatment (not including innovative processes such as 3D printing). The product is used for internal fixation and strapping in limb bone fracture.32Silic