Research Guides: BMEG260: Introduction to Medical Device Design: Major Standards Bodies

Major Standards Bodies

This section includes a subject specific select list of standards bodies related to engineering and technology. It contains a select list of professional societies that have multiple functions and develop standards as part of their organization's mission. The focus here is only on their standards work. Individual, full-text standards in print and/or digital formats are available for purchase from every standards body listed.

American National Standards Institute (ANSI)
As the only accreditor of U.S. voluntary consensus standards bodies, ANSI facilitates the approval of American National Standards (ANS). It is the "sole U.S. representative and dues-paying member of the two major non-treaty international standards organizations, the International Organization for Standardization (ISO), and, via the U.S. National Committee (USNC), the International Electrotechnical Commission (IEC)" (ANSI 2017). Through ANSI or the USNC, U.S. standards are often submitted to ISO and IEC to be used in whole or in part as international standards. ANSI offers institutional access to their approved standards, as well as U.S. and international standards from many other standards bodies, through the online platform ANSI Standards Connect ET.

Below is a list of the standards developers (aka SDO) whose standards are available for retail or subscription purchase through ANSI:

Acoustical Society of America: ASA
The purpose of the Acoustical Society of America is to generate, disseminate, and promote the knowledge and practical applications of acoustics. Established in 1929, the present membership includes leaders in acoustics worldwide. Diverse fields of interest in acoustics include physics, engineering, architecture, noise, oceanography, biology, speech and hearing, psychology and music.
Association for the Advancement of Medical Instrumentation: AAMI
Association for the Advancement of Medical Instrumentation is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.
ASTM International
ASTM develops and publishes national and international standards for materials, products, systems, and services. ASTM standards are used in a variety of industries, including aircraft, chemical, construction, consumer product, energy, highway, metals, testing solutions, automotive, health care services, technology, and textiles. ASTM offers institutional access to their standards, other ASTM publications, and standards from other standards bodies (AASHTO, etc) through the online platform ASTM Compass.
IEC: International Electrotechnical Commission
IEC's activities, collectively known as electrotechnology, cover all electrical, electronic and associated technologies in the areas of power generation, transmission and distribution, medical equipment, semiconductors, fiber optics, nanotechnology and renewable energies. In addition to providing an excellent framework for improving safety and optimizing energy, IEC standards support trade between countries by providing a reference for the functioning of the World Trade Organization (WTO) Agreement on Technical Barriers to Trade.
ISO: International Organization for Standardization
ISO is an independent, non-governmental, international organization that develops and publishes consensus-based international standards. ISO publishes standards in almost every industry for materials, products, processes, and services.