US contributions to international standards for medical electrical equipment

摘要

In the United States, the requirements addressing the safety and performance of medical equipment are published by the FDA or the Nuclear Regulatory Commission or are promulgated by the states through their health departments. In many cases, specific requirements for safety and performance originate from standards published by the International Electrotechnical Commission (IEC). The design of equipment for radiology and radiation therapy is likewise affected a great deal by IEC standards.