IEC, ISO & International Standards

This is the first of a series of occasional columns discussing IEC, ISO & international standards and how they affect the ultrasound community. This segment provides a general description of who is who, who does what and why these activities are important to the ultrasound community.

There are 2 main international standards writing organizations that are of interest to the ultrasound community:

• The International Electrotechnical Commission (IEC)
• The International Standards Organization (ISO)

These organizations develop and distribute the majority of quality, safety, and environmental standards presently in use today. Through an international agreement, IEC develops mostly safety and technical standards, whereas ISO is typically responsible for process, environmental and quality system standards.

As the world has moved more and more toward a single global market, consumers, governments, and industry have begun to demand standardization. This has resulted in significantly safer products in all countries, not just the major industrialized ones. Standardization provides additional benefits through minimum performance guarantees to the customer; lower manufacturing costs, and greater value to the consumer. If manufacturers were forced to meet multiple regulatory or design requirements, 1 for every country, the gains from the economies of scale would be lost and, very possibly, the products would simply not be marketed in some areas.

All IEC and ISO standards are "voluntary." However, many government regulators now accept adherence to international standards as sufficient for meeting their regulatory requirements. This is true in the EU, Japan, North America, and many other countries around the world.

In the diagnostic ultrasound community, the following 3 standards are of most interest to clinical professionals:

• ISO 13485:2003: Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes. This standard specifies the requirements for the application of quality systems in organizations involved with medical device design, manufacture, and servicing. It is the medical industry equivalent to the better-known ISO 9000 requirement. When an organization certifies to ISO 13485, it verifies that a specified minimum level of quality and oversight is used in the development, manufacture, delivery, and maintenance of their medical devices or services.
• IEC 60601-1 ed2.2: Medical Electrical Equipment-Part 1: General Requirements for Safety. Certification to this standard ensures that a minimum level of product safety is provided with regards to almost all aspects of electromedical devices, including instructions for use, system labeling, mechanical hazards, electrical hazards, radiation hazards, and temperature hazards. For example, it specifies minimal opening sizes so no one can stick a finger in a cooling fan. Other areas covered by this standard include sharpness of edges to prevent cuts; surface temperature limits to prevent burns; grounding requirements to protect from electric shock; and documentation requirements to keep the user fully informed on how to use the product safely.
• IEC 60601-2-37 ed1: Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment. This standard establishes safety requirements for medical ultrasound diagnostic and monitoring equipment. The requirements in this standard work hand-in-hand with the IEC 60601 standard to either add subtract or modify its general requirements and so make them appropriate to diagnostic ultrasound. As is the case with many IEC standards, this standard was adapted from an existing local standard, the AIUM Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (also known as the "Output Display Standard" or "ODS"). For example, the requirements for the MI and TI displays seen on many modern ultrasound systems are defined in this standard.

Of course IEC and ISO are not the only organizations involved in the development of standards for the ultrasound community. For example, the AIUM develops and publishes a number of widely used standards. Nevertheless, this column will continue to focus on the activities and goings-on with IEC and ISO. Upcoming segments will discuss topics such as risk management, what's coming in the way of new standards, how can one get involved in the development of international standards, how standards affect regulation, "safety" standardization, when standards go "awry", and how standards affect your day-to-day work.

Questions may be directed to the author at: iec_iso@aium.org