IEC 601-1-2 and its impact on medical device manufacturers

The world of medicine is growing more dependent on electronics. Also, the congestion of devices in a hospital or clinic, and proliferation of new communication technologies, is forcing the medical devices to operate in a new hostile electromagnetic environment. IEC 601-1-2 titled “Medical Electrical Equipment. Part 1: General requirements for safety; 2. Collateral standard: Electromagnetic Compatibility-Requirements and tests” developed by International Electrotechnical Commission (IEC) sub-committee 62A helped establish a specific Electromagnetic Compatibility (EMC) standard for medical electrical equipment. It is widely used as a basis for EMC approval by several regulatory agencies. This paper discusses the emissions and immunity requirements in the standard. It describes the test limits to be met by the manufacturer and the rationale of the tests. This paper reviews the current requirements as well as provides an insight into the anticipated changes in the second edition of the standard