The state of medical devices in accordance with the risk level of implementation of classification management.
The first category is a low-risk medical device, the implementation of routine management can ensure its safety and effectiveness.
The second category is a medium risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Purpose is the diagnosis, prevention, monitoring, treatment or mitigation of disease; diagnosis, monitoring, treatment, mitigation or functional compensation of injury; physiological structure or physiological process testing, replacement, regulation or support; life support or maintenance; pregnancy control; through the examination of samples from the human body, for medical or diagnostic purposes to provide information.
Expanded Information:
According to Article 5 of the Rules for the Classification of Medical Devices Based on the factors affecting the degree of risk of medical devices, medical devices can be classified into the following situations:
(a) According to the difference in structural characteristics, is divided into passive medical devices and active medical devices.
(b) according to whether contact with the human body, divided into contact with the human body devices and non-contact human body devices.
(C) according to the different structural features and whether contact with the human body, the use of medical devices in the form of:
passive contact with the human body devices: liquid delivery devices, change the blood and body fluids devices, medical dressings, invasive devices, reuse surgical instruments, implantable devices, contraception and family planning devices, other passive contact with the human body devices.
Passive non-contact devices: nursing instruments, medical equipment cleaning and disinfection equipment, other passive non-contact devices.
Active contact with the human body devices: energy therapy devices, diagnostic and monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, other active contact with the human body devices.
Active non-contact human devices: clinical testing instruments and equipment, independent software, medical equipment sterilization equipment, other active non-contact human devices.
(D) according to the different structural features, whether contact with the human body and the form of use, the use of medical devices or its impact include the following situations:
Non-passive contact with the human body devices: according to the time limit for use is divided into temporary use, short-term use, long-term use; contact with the human body is divided into parts of the skin or cavities (mouth), traumas or tissues, the blood circulatory system or the central nervous system. central nervous system.
Passive non-contact human body devices: according to the degree of influence on the medical effect is divided into basic non-influence, slight influence, important influence.
Active contact with the human body device: according to the degree of damage that may be caused by the loss of control is divided into minor damage, moderate damage, serious damage.
Active non-contact human devices: according to the degree of impact on the medical effect is divided into basic non-influence, slight impact, important impact.
Baidu Encyclopedia - Medical Devices