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What are the classification standards methods of medical devices?

2020-04-29 17:20:11
Times


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1. The first category is the low risk level, the implementation of conventional management can ensure its safety effective medical devices. Such as: surgical instruments (knife, scissors, forceps, tweezers, hooks), scraping plate, medical X-ray film, surgical clothes, surgical caps, inspection gloves, gauze, bandages, drainage bags, etc.

2. The second type is a kind of medical device with moderate risk, which needs strict control management to ensure its safety effectiveness. Such as medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non absorbable suture, etc.

3. The third type is a kind of medical device which has high risk needs to take special measures to strictly control manage to ensure its safety effectiveness. Such as: implantable pacemaker, corneal contact lens, intraocular lens, ultrasound tumor focusing knife, hemodialysis device, implantable equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc.


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