Class I: most of the security risks are small surgical machine class equipment such as, medical X-ray film, wound post, stethoscope, mask, surgical cap, mask, medical X-ray film, wound post, etc., these devices are through routine management is sufficient to ensure its safety, effectiveness of medical devices.
Class II: there are security risks to its safety, the need for careful preservation of its effectiveness to control medical devices, such as sphygmomanometers, cardiac diagnostic equipment, thermometers, medical gauze, thermostatic incubators, cardiac diagnostic equipment, medical cotton wool, medical gauze, thermostatic incubators, etc..
Class III: is potentially hazardous to the human body, the safety and effectiveness of medical devices must be strictly controlled to give the use of medical devices such as: artificial crystals, implantable cardiac pacemakers, one-time use of sterile syringes or infusion tubes, artificial crystals, one-time use of sterile syringes or infusion tubes.
Expanded Information
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, monitoring, treatment, alleviation or functional compensation of injury; the examination, replacement, regulation or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
The medical device industry involves a number of industries such as pharmaceuticals, machinery, electronics, plastics, etc. It is a multidisciplinary, knowledge-intensive and capital-intensive high-tech industry. And the basic characteristics of high-tech medical equipment is digital and computerized, is a multidisciplinary, cross-field crystallization of modern high technology, and therefore is the major scientific and technological countries, international large-scale companies compete with each other on the heights, the threshold of intervention is higher.
Baidu Encyclopedia - Medical Devices