Safety

Chroma Systems Solutions, Inc. (Chroma USA)

The purpose of safety testing medical electronic equipment is to be sure that a device is safe from electrical hazards to the patient and 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 (the International Electrical Safety Standard for medical electronic equipment) is experiencing “global harmonization,” meaning it has been accepted and implemented around the world. The IEC60601 standard is mainly intended for product development where safety considerations must be taken into account early in the design phase of a product, however much of it is applied to production line testing since it is the only way for a manufacturer to be sure they are shipping safe product.