Electrical Safety Testing od Medical Electronic Equipment

Manufacturers of medical electronic equipment must be sure that their products are safe from
electrical hazards to the patient and to the caregivers. There are a number of UL, European, and
Canadian standards that serve as the ruling body on how medical products will be tested, one in
particular, IEC60601-1 (the International Electrical Safety Standard for medical electronic equipment) is
experiencing “global harmonization,” meaning it is being accepted and implemented around the world.1
The IEC60601-1 standard is mainly intended for product development, where safety considerations
must be taken into account early in the design phase of a product. However, it is also applied to
production line testing since it is the only way for a manufacturer to be sure they are shipping a safe
product. There are a number of areas of safety testing, which include leakage current, dielectric
breakdown, insulation resistance, and ground bond testing.