Medical product EMC

Abstract

With the advent of the second edition of IEC 60601-1-2 and the FDA's acceptance of consensus standards such as the IEC 610004-x series, the EMC landscape for medical electrical equipment is undergoing a significant change. The EMC test requirements for medical products are very similar to those applied to other types of products such as radio equipment, networking equipment, and information technology equipment. However, IEC 60601-1-2 incorporates many specific test application guidance notes that require special consideration. In addition, there are several dozen additional standards that address unique characteristics for particular products. In many cases, the EMC test levels or methods are modified from those given in IEC 60601-1-2 for these products. IEC 60601-1-2 sets out a list of compliance criteria associated with essential performance of the product. Correctly specifying these criteria is key to meeting the essential requirement for safety specified by the medical device directive. The standard also sets out requirements for information that must be provided to the user in the form of warnings and markings, the environment for which the product was designed, including limitations of use, and a list of accessories that may safely be used with the product The paper discusses the assessment methods required by IEC 60601-1-2 that could affect product design.