(a) the intended purpose
refers to the product specification, labeling or promotional materials contained in the use of medical devices should be achieved.
(ii) passive medical devices
Medical devices that do not rely on electrical or other energy sources, but can perform their functions through energy generated by the human body or gravity.
(C) Active medical devices
Any medical device that relies on electrical or other energy sources, other than energy generated directly by the human body or gravity, to perform its function.
(D) invasive devices
With the help of surgery all or part of the body through the body surface invasion of the body, contact with the body tissues, the blood circulation system, the central nervous system and other parts of the medical device, including interventional surgery in the use of the device, one-time use of sterile surgical instruments and temporary or short-term stay in the body of the device, etc.. Invasive devices in this rule do not include reused surgical instruments.
(E) reusable surgical instruments
Used in surgery for the process of cutting, cutting, drilling, sawing, grasping, scraping, pincer, pumping, clamping, etc., not connected to any active medical device, through certain processing can be reused passive medical devices.
(F) implanted devices
With the help of surgery in whole or in part into the body or the cavity (mouth), or for the replacement of the human epithelial surface or the surface of the eye, and at the end of the surgical process to stay in the body for 30 days (including) or more or by the body to be absorbed by the medical device.
(VII) contact with the human body devices
Directly or indirectly in contact with the patient or the ability to enter the patient's body medical devices.
(viii) the use of time limits
1. Continuous use of time: the medical device according to the intended purpose, the actual duration of the role of the uninterrupted;
2. Temporary: the expected duration of continuous use of the medical device is less than 24 hours;
3. Short-term: the expected duration of continuous use of the medical device in the 24 hours (including) or more, within 30 days;
4. Long-term: medical devices are expected to be used continuously for more than 30 days (inclusive).
(ix) Skin
Undamaged skin surface.
(J) cavity (mouth)
Oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other natural cavities of the human body and permanent artificial openings.
(XI) trauma
A variety of injury-causing factors in the human body caused by the destruction of the integrity of the tissue structure or dysfunction.
(xii) Tissue
The body's internal tissues, including bone, dental pulp or dentin, excluding the circulatory system and the central nervous system.
(xiii) Circulatory system
Vessels (except capillaries) and the heart.
(xiv) Central nervous system
Brain and spinal cord.
(xv) Stand-alone software
Software that has one or more medical purposes, does not require medical device hardware to accomplish its own intended purpose, and runs on a general-purpose computing platform.
(xvi) Medical devices with metrological test functions
Medical devices used for the determination of physiological, pathological or anatomical parameters, or the quantitative determination of energy or substances entering or leaving the human body, where the results of the measurements need to be accurately quantified and where the accuracy of such results would have a significant impact on the health and safety of the patient.
(XVII) chronic wounds
Long-term non-healing wounds formed by various causes, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, pressure ulcers. Article IV medical devices in accordance with the degree of risk from low to high, the management category is divided into Category I, Category II and Category III in turn.
The degree of risk of medical devices should be based on the intended purpose of medical devices, through the structural features, the use of forms, the use of state, whether contact with the human body and other factors. Article V based on the factors affecting the degree of risk of medical devices, medical devices can be divided into the following cases:
(a) according to the different structural features, 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 includes 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 influence on the medical effect is divided into basic non-influence, slight influence, important influence.