An electromedical device is defined as an electronic device with a part that can be applied directly to the subject or used to transfer energy to or from the patient. Applications include diagnosis, treatment, and monitoring of the patient’s health conditions, as well as alleviating or even eliminating pain.
Safety, both for the patient and health-care professionals, is the first requirement with which an electromedical device must comply. The IEC 60601 family of standards sets the requirements for safety, performance, and electromagnetic compatibility of electromedical equipment.
Compliance with IEC 60601 standards can be achieved only through careful evaluation of all phases of the product development cycle, starting from the selection of the components.