Why IEC 60601-1?

The basic scope of IEC 60601-1 is safety of patient, user and the equipment. Before launch of the Medical equipment in the market , It must be be tested as per the safety standard. All the accessories used with the equipment must be tested as per Particular standard  IEC 60601-2-X series. It is also a mandatory standard for CE, UL and CSA marking.

medical devices - IEC 60601 testing

Classification of Electro medical equipment:

There are 3 main classifications for Medical Equipment to indicate protection against Electric Shock

  1. Class 1 equipment relies on a protective earth.
  2. Class 2 equipment relies on double layers of insulation.
  3. Class 3 equipment is internally powered below the Safety Extra Low (SELV) level of 50 Vac

Why IEC 60601-1 is Important?

It ensure the safety of operator, patient and equipment itself. Below are some of the risks associated with such equipment.

  • Extravagant currents result in an electrical shock to the user or patient, to overcome this  hazard, safety standards are introduced .
  • Exceptionally high currents passing through the body cause tissue heating.Cutting, Coagulation and Physiotherapy Ultrasound are controlled uses of this effect.
  • High-frequency surgical equipment may burn the operator/ patient.
  • Due to abnormal working of incubation,high frequency surgical equipment increase in temperature of Medical Equipment.
  • An increase of respiratory via pressure caused by an abnormal working of ventilators.

Requirements of Electro medical equipment

  • Robustness of the enclosure- It must be strong enough to be used normally without any mechanical damage.
  • Earthing: It must be earthed properly so that there is no Leakage of current and must be electrical shock proof. Protective Earthing (PE) is a usual way to reduce electrical hazards by making a low resistance path in the case of a fault. Double insulated equipment does not require a safety earth because no mains parts are accessible.
  • Single Fault Condition: It must work safe in normal condition and also remain safe during single fault condition .