International standardization and regulations for medical electrical equipment

Abstract

Medical electrical equipment is highly regulated and held to a higher level of safety than nearly all other types of equipment on the market. This kind of equipment refers to any piece of equipment that runs on electric power, battery or mains (plug-in or permanently connected). Over the last 50 years, medical offices have become increasingly populated with highly complex equipment used to diagnose and treat medical conditions. The complexity of the task of ensuring that this equipment maintains the safety of the patient and the operator has grown as the equipment‘s complexity has grown.