EMC (Electromagnetic Compatibility) Standard for Medical Devices.

摘要

The report fulfills requirements of FDA Contract 223-74-5246to research,evaluate,and document performance parameters and methods of test for use in an electromagnetic compatibility (EMC) standard for medical devices. The objectives were met by performing a comprehensive literature search;measuring the electromagnetic emissions in hospital environments;developing drafts of the standard;testing medical devices in accordance with the contents of the standard;and conducting a series of open public reviews on the standard. This report contains a summary of the literature search and titles of the documents reviewed; a description of the hospital survey test equipment and procedures; a summary of the hospital survey results;the results of the EMC standard evaluation task; a summary of the contents of the third draft of the EMC standard for medical devices;and the actual third draft.