* * * 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.
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:
We have identified, so far, 31 "particular" standards that address safety
and effectiveness issues for the following medical devices:
- 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
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.
- 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 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
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.
Robert F. Munzner, Ph.D.
Chair, EMBS Standards Committee