This is a select list of predominant medical device standards UL tests against and/or provides engineering expertise related to. UL also provides testing services to new technologies in advance of standards being published.
Please contact us with any questions in relation to this or other industry standards.
The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.
Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).
The American National Standards Institute (ANSI) has served in its capacity as administrator and coordinator of the United States private sector voluntary standardization system for more than 100 years. Founded in 1918 by five engineering societies and three government agencies, the Institute remains a private, nonprofit membership organization supported by a diverse constituency of private and public sector organizations.
ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of standards developing organizations (SDOs). These groups work cooperatively to develop voluntary national consensus standards. Accreditation by ANSI signifies that the procedures used by the standards body in connection with the development of American National Standards meet the Institute’s essential requirements for openness, balance, consensus and due process.
As of January 2018, some 237 standards developers were accredited by ANSI; there were more than 11,500 American National Standards.
ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
ASTM International standards are the tools of customer satisfaction and competitiveness for companies across a wide range of markets. Through more than 140 technical standards-writing committees, we serve a broad range of industries: metals, construction, petroleum, consumer products and many more. When new industries — like nanotechnology, additive manufacturing and industrial biotechnology — look to advance the growth of cutting-edge technologies through standardization, many of them come to ASTM International.
IEC provides a platform to companies, industries and governments for meeting, discussing and developing the International Standards they require.
All IEC International Standards are fully consensus-based and represent the needs of key stakeholders of every nation participating in IEC work. Every member country, no matter how large or small, has one vote and a say in what goes into an IEC International Standard.
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.
Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.