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U.S. Department of Health and Human Services

Radiation-Emitting Products

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CDRH References on Medical Device Electromagnetic Compatibility

THE FOLLOWING DOCUMENTS ARE AVAILABLE FROM CDRH/DSMICA

Radiowaves May Interfere with Control of Powered Wheelchairs and Motorized Scooters. Food and Drug Administration (September 20, 1994). 4 pages.

Witters, D.M. Medical Devices and EMI: The FDA Perspective. ITEM Update (ISBN 1040-4716, 1995), pp. 22-32.

THESE ADDITIONAL REFERENCES MAY BE OBTAINED FROM THE CITED PUBLISHER:

Bassen, H.I., Witters, D.M., Ruggera, P.S., Casamento, J.P. CDRH Laboratory Evaluation of Medical Devices for Susceptibility to Radio-Frequency Interference. Designer's Handbook: Medical Electronics, 3rd edition (1994), pp. 44-49.

Bassen, H.I., Ruggera, P.S., Casamento, J.P., Witters, D.M. Sources of Radiofrequency Interference for Medical Devices in the Non-clinical Environment. IEEE (ISBN 0-7803-2050-6, 1994), pp. 896-897.

Bassen, H.I., Ruggera, P.S., Casamento, J.P. Changes in the Susceptibility of a Medical Device Resulting From Connection to a Full-Size Model of a Human. IEEE (ISBN 0-7803-0785-2, 1992), pp. 2832-2834.

Bassen H.I., Ruggera, P.S., O'Bryan, E.R., Casamento, J.P., Silberberg, J.L. Medical Device RF Susceptibility - Research and Proposed Standards for Infant Apnea Monitors. EMC Technology Magazine Expo '92 International Conference on Electromagnetic Compatibility Technical Record (1992), pp. 256-260.

Ruggera, P.S., O'Bryan, E.R., Casamento, J.P. Automated Radiofrequency Electromagnetic Interference Testing of Apnea Monitors Using an Open Area Test Site. Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 14 (1992), pp. 2839-2841.

Silberberg, J.L. What Can/Should We Learn from Reports of Medical Device Electromagnetic Interference? Compliance Engineering, Vol. XIII, No. 4 (May/June 1996), pp. 41-57.

Silberberg, J.L. Performance Degradation of Electronic Medical Devices Due to Electromagnetic Interference. Compliance Engineering, Vol. X, No. 5 (Fall 1993), pp. 25-39.

Sykes, S., ed. Forum on Electromagnetic Compatibility. FDA/AAMI Conference Report (proceedings available from the Association for the Advancement of Medical Instrumentation, Arlington, Virginia), May 1995 (ISBN 1-57020-054-8).

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