The term "Type B device" is specifically for "shock protection". It does not refer to the medical device classification.
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Medical electrical equipment can be divided into three categories according to the "degree of equipment protection against electric shock":
Type B: equipment with specific protection against electric shock. 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.
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Medical devices are divided into 3 categories, "I, II, III", not "A, B, C":
Type I is the type of device that is used in the heart. p>
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, issued by the 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 body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.
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