Class B

In the past, a medical device was classified overall according to its areas of application, but now it is only the applied parts of the medical device that are classified. In the medical standard IEC/EN 60601-1 3rd Edition, the maximum permissible patient leakage currents in normal operation and after a single fault are determined according to this classification. Depending on the classification of the application part, various limit values must be adhered to.

A distinction is made between type B (body), type BF (body float) and type CF (cardio float).

Type B (body, body cover): In an application part of type B, no current transmission to the patient is desired, but in principle conceivable (e.g. for lighting in operating theatres).

Type BF (Body Floating): An application part of type BF is connected to the patient's body to transmit electrical energy or an electrophysiological signal to or from the body (e.g., ECG devices).

Type CF (Cardial Floating): An application part of type CF is connected to the patient's body in order to transfer electrical energy or an electrophysiological signal to or from the body (e.g. external cardiac pacemakers) as part of a direct application to the heart.

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