Applicable Products
Medical device testing products：
1. About active products
Multi-parameter monitors, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, non-invasive blood pressure monitoring equipment, pulse photo oximeter equipment, high frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, EEG machines, surgery Surgery, cosmetics, diagnosis and treatment laser equipment, electrocardiogram diagnosis equipment, etc., clinical chemistry analysis equipment, immunochemical analysis equipment, automatic blood analysis equipment, microbiological analysis equipment, automatic protein analyzer, biochemical analyzer, blood cell analyzer, blood gas analyzer, chemistry Luminescence immunoassay analyzer, urine sediment analyzer, blood coagulation analyzer, automatic blood rheometer, automatic internal bacterial culture analyzer, microorganism identification and bacterial sensitivity analyzer, nucleic acid purification instrument, blood tissue culture instrument, cryostat , Biological tissue dehydration or, tissue embedding machine, centrifuge, mixer, dyeing machine, high temperature pulse vacuum sterilizer, high temperature steam sterilizer, infrared electric sterilizer, high temperature disinfection washing machine, biological safety cabinet, etc.
2. About Non-active Products
1. Surface contact equipment
Electrodes, external prostheses, fixation bands, compression bandages and various types of monitors, etc.
Contact lenses, urinary catheters, intravaginal or digestive tract equipment (gastric tube, colonoscope, gastroscope), tracheal intubation, bronchoscope, etc.
It is used for dressings or nursing equipment for ulcers, burns, granulation tissue and sealing dressings.
2. External access device
Blood transfusion, infusion set, extender, transfer device, etc.
Laparoscopy, arthroscopy, drainage system, dental filling materials, skin nails, etc.
Intravascular catheters, temporary pacing electrodes, dialyzers, dialysis tubing and accessories, vascular adsorbents, immunoadsorbents, etc.
3. Implantation device
Orthopedic nails, artificial joints, prostheses, bone cement and intraosseous devices, pacemakers, implantable drug delivery devices, neuromuscular sensors and stimulators, artificial tendons, breast implants, artificial larynx, subperiosteal implants, Lashing clips, etc.
Pacemaker electrodes, artificial arteriovenous fistulas, heart valves, artificial blood vessels, internal drug delivery catheters and ventricular assist devices, etc.
Introduction
Medical devices are related to human health and safety, and related issues have become the focus of common concern for manufacturers and consumers. Shenzhen Huatongwei is one of the first third-party laboratories engaged in active medical device testing in China. It provides long-term medical product testing services for domestic and foreign medical device manufacturers.
1. Test items
Routine safety testing:
Temperature rise, withstand voltage, leakage current, defibrillation protection test, mechanical test, single failure test, etc.
Electromagnetic compatibility test:
Power terminal interference voltage, radiation interference, harmonic current, voltage fluctuation and flicker, electrostatic discharge immunity, radio frequency radiation immunity, power frequency magnetic field immunity, electrical fast transient pulse group immunity, radio frequency conduction immunity Disturbance, surge immunity, voltage sag, short-term interruption and resistance to voltage changes.
Product-specific standard tests:
For example: blood pressure accuracy, blood oxygen accuracy, accuracy testing of infusion pumps and infusion controllers, and performance testing of a series of products, such as monitoring, nerve and muscle stimulators.
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In vitro cytotoxicity test
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Subacute systemic toxicity test
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Salmonella typhimurium revertant
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Platelet adhesion test
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Sensitization test
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Complement activation test
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Gene mutation test
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Subchronic systemic toxicity test
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Thrombosis test
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Chronic systemic toxicity test
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Skin irritation test
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Muscle implantation test
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Intradermal stimulation test
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Hemolysis test
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Coagulation test
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Heat source test
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Acute systemic toxicity test
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Chromosome aberration test
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Material characteristic analysis
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Bone implant test
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Subcutaneous implantation test
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Bone marrow micronucleus test
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Endotoxin
Physical and chemical performance test
Packaging verification Validation of cleaning and disinfection
Biosafety assessment
Preclinical functional evaluation
