scope:

Foreword

This recommended practice was developed over a period of two years (1995˘1997) in response to a need expressed by clinical and biomedical engineers for a technical guide to aid them in assessing the immunity of medical devices to radiated electromagnetic ˝elds from portable RF transmitters. It is based in part on ad hoc test methods that were used by Dr. Kok-Swang Tan, Medical Devices Bureau, Health Canada, and Dr. Bernard Segal, McGill University and Jewish General Hospital, Montreal.

As wireless communications equipment, especially cellular telephones, have increased in popularity, the need to manage the use of communications equipment in the health-care environment has become apparent. This recommended practice will provide an economical means of obtaining objective data on which to base such management practices, allow health-care organizations to readily assess the immunity of electrical medical devices to portable RF transmitters that might be used nearby, and improve the consistency of such ad hoc Electromagnetic Compatibility (EMC) measurements between health-care facilities.

Scope

This recommended practice is intended to serve as a guide for health-care organizations in evaluating the radiated radio-frequency (RF) electromagnetic immunity of their existing inventories of medical devices to their existing inventories of RF transmitters, as well as to RF transmitters that are commonly available. It can also be used for newly purchased medical devices and RF transmitters, as well as for prepurchase evaluation. This recommended practice applies to medical devices used in health-care facilities and to portable transmitters with a rated power output of 8 W or less. It does not apply to implantable medical devices, transport environments such as ambulances and helicopters, or to RF transmitters rated at more than 8 W. Testing with transmitters greater than 8 W should not be performed in health-care facilities because of possible adverse effects on critical-care medical devices that are in use in other areas of the facility.