Medical equipment classification in one, two, three specific only what? What is the classification basis?
Contact or into the human body equipment and non-contact human body equipment, the specific can be divided into:
1. contact with or enter human body equipment
(1) the use of time is divided into: temporary use; short-term use; long-term use.
(2) contact with the body parts are divided into: skin or cavity; trauma or in vivo tissue; blood circulation system or central nervous system
System.
(3) active equipment out of control caused by the degree of damage is divided into: minor damage; injury; serious injury.
2. Non-contact human body equipment
The impact on the medical effect, the degree is divided into: the basic does not affect; have an indirect effect; have an important impact.
Article 6 The principle of judging the classification of medical devices
(A) the implementation of medical equipment classification, should be based on classification criteria table.
(2) The classification of medical devices is mainly determined according to its intended use and purpose. If the same product is used
And the role of different ways, classification should be judged separately.
(C) medical devices used in conjunction with other medical devices, should be classified separately; medical equipment accessories classification
Should be separated from its supporting host, according to the situation of the annex separate classification.
(D) the role of several parts of the body of medical equipment, according to the use of high risk forms, the use of state classification.
(5) The software that controls the function of the medical device and the medical device are classified according to the same category.
(Vi) If a medical device can be applied to two categories, the highest classification should be taken.
(7) Products that monitor or influence the main functions of medical devices, the classification of which is consistent with the classification of the equipment being monitored and affected.
Article 5 The basis for judging the classification of medical devices
(A) the characteristics of medical equipment
The structural features of medical devices are divided into: active medical devices and passive medical devices.
(B) the use of medical equipment form
According to the different intended purpose, the medical device into a certain form of use. among them:
1. The use of passive equipment in the form of: liquid delivery preservation equipment; change the blood, body fluid equipment; medical dressings;
Surgical instruments; repeated use of surgical instruments; disposable sterile equipment; implantation equipment; contraception and family planning equipment;
Cleaning equipment, in vitro diagnostic reagents, other passive contact or passive auxiliary equipment.
2. The use of active devices in the form of: energy treatment equipment; diagnostic equipment; transport body fluid equipment; ionizing radiation
Equipment; laboratory equipment, medical disinfection equipment; other active equipment or active auxiliary equipment.
(C) the use of medical equipment status
According to the use of the possibility of injury to the human body, the impact on medical effects, the use of medical equipment can be divided into
Meinova Medical Solutions: The first is to regulate the classification of medical devices, in accordance with the "Medical Device Supervision and Management Regulations" to develop these rules.
Article 2 Medical devices refer to instruments, equipment, appliances, materials or other materials that are used alone or in combination with the human body
Items, including the required software. The purpose of its use is:
(A) the prevention, diagnosis, treatment, monitoring or remission of the disease.
(2) diagnosis, treatment, monitoring, remission or compensation of injury or disability.
(C) research, substitution or regulation of anatomical or physiological processes.
(D) pregnancy control.
Its body surface and the role of the body is not used pharmacology, immunology or metabolic means to obtain, but may have this
Some means to participate and play a supporting role.
Article 3 These Rules shall be used to guide the formulation of the Catalog of Medical Device Classification and to establish a new category of product registration.
Article 4 The classification of medical devices shall be based on the structural characteristics of medical devices, the form of medical devices and medical devices
The use of three aspects of the situation to conduct a comprehensive decision.
The specific judgment of the classification of medical devices can be based on the "Medical Device Classification Judgment Form" (see Annex).
