The 2nd edition of IEC 60601-1 established risk guidelines that applied when a device was within a 6-foot radius from the patient, referred to as the “patient vicinity.” The standard further classified medical equipment into three categories. Type B (body) equipment that operates within the patient vicinity, but without patient contact. Type BF (body floating) equipment is characterized by having direct contact with the patient. Type CF (cardiac floating) equipment has direct contact with the patient’s heart. Each classification had different required standards for isolation, insulation, creepage, clearance, and leakage.