IEC60601 AAMI/NFPA 99
The primary standard for medical devices is IEC 60601. General requirements for protection against electric shock hazards are covered in IEC 60601.1, Section 3.
In this standard, each instrument has a class:
Class I—Live part covered by basic insulation and protective earth
Class II—Live part covered by double or reinforced insulation
Class IP—Internal power supply
Each patient applied part or patient lead has a type:
Type B—Patient applied part earthed
Type BF—Patient applied part floating (surface conductor)
Type CF—Patient applied part floating for use in direct contact with the heart
Leakage measurement limits have been developed for equipment types and measurements. They include:
NC—normal conditions
SFC—single fault conditions
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
