II,
III".
Type I refers to medical devices whose safety and efficacy can be ensured through routine management. Generally by the City Food and Drug Administration to approve, issue a registration certificate.
Type II refers to its safety, effectiveness should be controlled medical devices. Generally by the provincial Food and Drug Administration to approve the registration certificate issued.
Type III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Active medical electrical equipment in accordance with the "degree of protection of the device against electric shock" can be divided into three categories:
Type B: specific protection against electric shock equipment. Such as: color ultrasound, electronic blood pressure monitor.
BF type: with F-type isolation application part of the B-type equipment. Such as: physiotherapy low-frequency electronic pulse therapy equipment.
CF type: directly applied to the heart of the device. Such as: electrocardiograph, cardiac monitor.