IEC Organization and Diagnostic Ultrasound

This column will appear occasionally in Sound Waves and will discuss topics concerning the IEC (International Electrotechnical Commission), ISO (International Standards Organization), and international standards and how they affect the ultrasound community.

The IEC develops standards by means of collaboration and consensus among international experts and their national committee colleagues. The primary vehicle through which this collaboration takes place is the Technical Committee, or TC. There are presently 89 Technical Committees in the IEC covering a wide variety of topics from wire insulation to medical devices. Depending on the scope, a TC may be divided into smaller Subcommittees-or SCs. Each TC or SC is made up of Working Groups (WGs) and Maintenance Teams (MTs). It is within the Working Groups and Maintenance Teams that the collaboration and the hands-on document development takes place. Working Groups develop new documents whereas Maintenance Teams are responsible for revisions and amendments to existing documents. WGs and MTs typically consist of 5 to 20 experts and generally are dedicated to a single document or project. Participants, or experts, are assigned by their country's IEC governing body-their National Committee (NC). Many countries will also convene a "mirror committee" within their own country made up of all the experts that country supplies to the corresponding TC or SC. In the United States, these mirror committees are referred to as Technical Advisory Groups (TAGs).

Each TC or SC has a chairman and secretary tasked to administer the work of the committee. The chairman and secretary are selected by the National Committees through a series of procedures defined in the ISO/IEC Directives. Each WG and MT has a convenor selected by its parent TC or SC.

There are 2 IEC committees that develop standards for diagnostic ultrasound equipment:

SC62B: Medical Electrical Equipment-Diagnostic Imaging Equipment
SC62B develops standards for diagnostic imaging devices and is 1 of 4 subcommittees that make up TC62. Standards regarding the safety of medical diagnostic ultrasonic fields and the equipment/systems that produce them are the responsibility of SC62B. There is presently 1 ultrasound particular standard within the SC62B catalog: IEC 60601-2-37 ed1: Medical electrical equipment-Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. The development of amendments and future editions of this standard is managed by Maintenance Team (MT) 34. MT34 coconvenors are John Abbott (US) and Massimo Polignano (IT). The secretary is Norbert Bischof (DE).

TC87: Ultrasonics
TC87 is responsible for standards applied to ultrasonic applications such as medical, industrial, and underwater. Topics presently managed by TC87 include high-power transducers, focused transducers, ultrasonic surgical equipment, ultrasonic field measurement, pulse-echo diagnostic equipment, ultrasonic diagnostic flow measuring and imaging systems, terminology, ultrasound exposure parameters, and safety of nonmedical devices. TC87 works closely with TC62 to develop ultrasound safety standards for therapeutic devices.

The TC87 catalog of ultrasound standards is broad and includes measurement standards, performance standards, calibration standards, and terminology standards. A complete list of the publications issued by TC87 may be viewed at the IEC website (www.iec.ch) - TC/SC dashboard: "87."

The chairman of TC87 is John Abbott (US), and the secretary is Nick Bradfield (UK).

Ultrasound experts in the United States interested in participating in the development of international ultrasound, either by active participation in the committees or by correspondence, may contact the author at iec_iso@aium.org.

John Abbott, PhD,
IEC Liaison for the AIUM