CE 등급 B. BF, CF의 의미

FDA는 Class A, B, C로 나뉘고, CE는 B, BF, CF로 나뉩니다. 

그 의미는 아래와 같습니다. 

Type CF (“Cardiac Floating”) is the most stringent classification, and is used for applied parts that may come in direct contact with the heart, such as dialysis machines.

Type BF (“Body Floating”) is less stringent than Type CF, and is generally used for applied parts that have conductive contact with the patient, or having medium or long term contact with the patient.  Examples of this type of equipment are blood pressure monitors, incubators and ultrasound equipment.

Type B (“Body”) is the least stringent classification, and is used for applied parts that are normally not conductive and can be immediately released from the patient.  Examples of that would be LED operating lighting, medical lasers, MRI body scanners, hospital beds and phototherapy equipment.

Type B applied parts may be connected to earth ground, but Type BF & CF are separated from earth – hence the term “floating”.

Power supply Isolation Voltages vary according to the type rating.

Type	Input to Output Isolation	Input to Ground Isolation	Output to Ground Isolation
B rated	4000VAC	1500VAC	500VAC
BF/CF rated	4000VAC	1500VAC	1500VAC