Stricter Medical Equipment Certification Standards Improve Protection for Medical Patients and Facilities

Increased concern for patient well-being is resulting in more technical certification standards for electronic medical systems than ever before. Agencies such as the U.S. Food & Drug Administration (FDA) and European Union Medical Device Directive (MDD) have enacted stricter regulations to govern product attributes from the electrical to the ergonomic and beyond. Driving these tougher standards are advances in the technology itself. Just a few years ago, there was little electronic equipment located near a patient. Today, the patient's bedside bristles with a variety of systems, many of them electromagnetic and generating radiation, others wireless and creating a web of emissions. Systems for monitoring a patient's vital functions, terminals for entering patient data and systems for generating charts - plus an array of portable monitoring, scanning and x-ray equipment - all contribute.

Then there's the issue of electromagnetic immunity. In this sense, immunity is defined by the FDA as "the ability of an electrical or electronic product to operate as intended without performance degradation in the presence of an electromagnetic disturbance." In Europe, the greatly increasing amount of electromagnetic activity in medical equipment has led to issuing a strict new standard - IEC 60601-1-2, 2nd Edition - that dramatically increases the level of protection in medical facilities. The standard requires manufacturers to perform extensive analysis to assure that equipment or systems have adequate immunity to electromagnetic disturbances.