* * * Standards Committee Report, Fall 1998 * * *

Committee Activities (Summary)

Since the period reported at Spring AdCom meeting, Committee business has been transacted entirely by E-Mail. Recently, a "majordomo" mailing list was established in the IEEE server which should facilitate committee conferencing through the internet. The first "virtual" meeting has been initiated and is scheduled for completion in 30 days.

The committee now has operating procedures in place that are harmonized with ANSI and IEEE Standards Board requirements; however, it is anticipated that further refinements will be needed. The committee has maintained liaison with the IEEE Standards Board and the IEC TC/SC 62 (Electrical Equipment in Medical Practice).

A web site is being maintained to summarize the standards applicable to electronic medical devices that have been published, as well as current IEEE projects applicable to medical device standards. The web site now has a link from the EMBS home page, under "Committees" (thanks to Susan Blanchard).

IEEE Standards Board Liaison

A report of IEEE Standards Board activities that may affect members of the EMBS is provided in Attachment 1.

IEC TC/SC62 Liaison

Mr. Steli Loznen attended the May 15th IEC Committee meetings in Canada, as the EMBS liaison. He reported that coordination with the IEEE 1073 committee has been established. He also provided documentation of 23 recommendations for revision of IEC 601-1 from Working Group 14.

Standards Survey

The current results of the ongoing survey of medical device standards and standards activities appear on the EMBS Standards web site as four cross-linked pages. To summarize, there are 33 "general" standards that address the following concerns:

Electrical Safety
Ionizing Radiation Safety
Radio Frequency Radiation Safety
Light Emission Safety
Sound and Ultrasound Emission Safety
Software Safety and Reliability
Electromagnetic Environment Compatibility (Emissions and Vulnerability)
Data Exchange Format Compatibility

We have identified, so far, 31 "particular" standards that address safety and effectiveness issues for the following medical devices:

Anesthesia Delivery Devices, Apnea Monitors, Blood Pressure Monitors,
External Cardiac Defibrillators, Implanted Cardiac Defibrillators,
Cardiac Pacemakers, Diathermy Devices, Electrocardiographs,
Electroconvulsive Therapy Devices, Electroencephalographs,
Electromyographs, Electrosurgical Devices, Evoked Response Stimulators,
Gamma Beam Therapy Devices, Hearing Aids, Heating Blankets,
Hospital Beds, Infant Incubators, Intracranial Pressure Monitors,
Lasers, Ultrasonic Lithotripsy Devices, Magnetic Resonance Imaging,
Microwave Therapy Devices, Nerve Conduction Velocity Measurement
Devices, Nystagmographs, Nuclear Imaging Devices,
Implanted Nerve Stimulators, Radiation Therapy Devices and Dosimeters,
Implanted Spinal Cord Stimulators, Transcutaneous Electrical Nerve
Stimultors, Ultrasound Imaging Devices, Ventilators, Wheel Chairs,
and Diagnostic X-ray Equipment.

The web site also identifies, and provides URL links to, 34 standards development organizations, which are cross linked to the medical device standards they have developed. "Comment" pages have been constructed for 16 standards which provide details on the structure and the extent of development, but clearly more work is needed in this area.

Budget

The Committee did not request any financial support at the 1997 Fall AdCom meeting. The Vice President for Publications and Technical Activities generously contributed $1000 to the Committee to partially (about 30%) compensate the Chair for unanticipated expenses incurred by attending all meetings of the IEEE Standards Board during the past year. AdCom is hereby requested to provide a budget of $2500 to support similar activities in 1999. The Chair is personally providing support for the current Committee expenses. The IEEE Standards Board plans to have four meetings again next year, but the current plan will not require any international travel.

Future Direction

Our survey of existing medical devoce standards shows that they vary greatly in degree of development. An important goal for the coming year is to examine each of them and determine where EMBS should encourage, or even support, further development. The expansion of the EMBS Standards Committee to include new standards development should also be considered.

Respectfully submitted,

Robert F. Munzner, Ph.D.
Chair, EMBS Standards Committee