Classification Biomedical Equipment

Classification of medical Equipment (Applied parts)

Applied parts are classified as Type B, Type BF or Type CF according to the nature of the device and the type of contact. Each classification has differing requirements from the point of view of protection against electrical shock.





ECG Recorder



Type CF is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary.








Doppler

Type BF is less stringent than CF, and is generally for devices that have conductive contact with the patient, or having medium or long term contact with the patient.


Type B is the least stringent classification, and is used for applied parts that are generally not conductive and can be immediately released from the patient





Incubator


Type B applied parts may be connected to earth, while Type BF and CF are 'floating' and must be separated from earth.



Classification of medical Equipment ( insulation )

Basic Insulation
Insulation applied to live parts to provide basic protection against electric shock.

Class I Equipment

Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductorin the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of basic insulation.

Class II Equipment

Equipment in which protection against electric shock does not rely on basic insulation only, but which additional safety precautions such as double insulationor reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions.