Spring AdCom 2001

Standards Committee Report

Robert Munzner, Chair and IEEE Standards Board Liaison

Active Members:

Guy Hammer, Vice Chair Carole Carey, Secretary
Rory Cooper, ANSI/ISO Liaison
Steli Loznen, IEC/TC62 Liaison
Gideon Kantor
Arthur Sherwood
Alvin Wald


Summary of Committee Activities

All committee business is presently being conducted by E-mail representation, using a reflector list (EmbStdCom@ieee.org) on the IEEE server.

A public web site (http://www.ewh.ieee.org/soc/embs/embs_standards) is being maintained that lists standards and standards projects directly applicable to medical devices and the biological effects of energy.

The committee is maintaining liaison with ANSI, ISO/CEN/TC293, IEC/TC62, and the IEEE Standards Board.

Steli Loznen attended he IEC/TC 62 met on November 9, 2000 in Tokyo. Fifty delegates from 16 countries were present. The 2nd Committee Draft of 3rd edition of General Standard IEC 60601-1 was circulated and comments from National Committees are expected at the end of March 2001. The structure of the 3rd edition 60601-1 is now fixed. Safety Standard in Diagnostic Ultrasound IEC 60601-2-37 has reached the FDIS stage. The Secretary of SC 62B has created a document that compiles the terms defined in the standards written by TC 62. Working groups are now active on developing standards for patient monitoring equipment, therapy equipment, electro-optical equipment, cardiac pacemakers, haemodialysis equipment, infusion pumps, pediatric equipment, hospital beds, lithotripsy, illumination for surgery and diagnosis, defibrillators, high frequency surgical instruments, critical care ventilators, and anaesthesia workstations. The responsibility for the standards on X-ray films and screens to being transferred to ISO TC 42. The next meeting of TC 62 is scheduled to take place on October 19th, 2001 in Florence.

The committee Secretary, Carole Carey, attended the ISO TC150/SC6 and IEC SC62D WG6 (Cardiac Pacemakers and Implantable Defibrillators), December 6-8, in London as an FDA liaison. There was discussion of the Emergency Intervention System (ISO 14994) to provide for non-invasive implant identification, emergency programming, and a universal programmer concept. A revision of ISO 584-1 (cardiac pacemakers) is being drafted The next meeting will be in New York, April 2001.

Dr. Rory Cooper received an IEEE-SA Professional Leadership award for his work in developing international standards.

A quarterly report of the IEEE Standards Board activities is provided to the EMBS President, to the Vice President for Publications and Technical Activities, and to the EMBS Standards Committee members by the Chair.

The Committees bylaws were revised in accordance with new ANSI accreditation requirements and approved by the Committee on January 25, 2001. The bylaws are posted on the Committee=s web site.

IEEE Standards Board Meetings

The Board and its committees met January 27-30 in Singapore on conjunction with the Power Engineering Society annual meeting. Board and committees were held March 28-30, June 19-21, and September 19-21 in Piscataway, New Jersey, and in New York City, December 5-7. The EMBS liaison was a member of the New Standards Committee and a voting member of the Board for the year 2000 and has attended all meetings to date. The next meeting will be held in Hilton Head, South Carolina, in conjunction IEEE 802 Standards meetings, March 15-17, 2001.

During the past year the IEEE Standards Coordinating Committee (SCC) 28 began a new project to amend to C95.1, AIEEE Standard for Safety Levels with Respect to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHZ,@ which was published last year. This document provides a valuable reference to consumer enquiries concerning the risk associated with electromagnetic devices addressed the IEEE. Ronald C. Petersen, the Secretary of SCC28 was elected to chair the the new International Electrotechnical Committee (IEC) TC106. The charge of this new committee, the assessment of human exposure to electromagnetic fields, is similar to that of IEEE Standards Coordinating Committees 28 and 34. SCC-28 is also working on a standard for the acceptable level of human exposure to electromagnetic fields, 0 to 3 KHZ.

The EMBS Medical Information Bus (MIB) Committee, which does not report to the EMBS Standards Committee, continues with a large project to develop communications standards for medical devices. This committee, chaired by Robert Kennelly, continues to report directly to the EMBS president.

Budget

The committee requested the sum of $1400 for the year 2000; however, no support was provided by EMBS. Operating costs for the year 2000 were absorbed by the chair. The committee continues to operate on volunteer effort and personal resources. The committee chair respectfully requests a budget of $1200 to help defray the cost of attending quarterly Standards Board meetings.

Future Activities

The Committee intends to sponsor a project to obtain IEEE adoption of the ANSI/RESNA Wheelchair Standard under the leadership of Rory Cooper. We hope to have this project authorized by IEEE this coming year. Also, we intend to assist IEC TC62 in the development of their terminology data base.

Respectfully submitted,

Robert F. Munzner, Ph.D.

March 2001