Medical Device Standards Portal -- U.S.A.
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The Leaders
in Medical Device Standards
AAMI
The Association for the Advancement of Medical Instrumentation (AAMI), a nonprofit organization founded in 1967, is a unique alliance of nearly 6,000 members from around the world united by the common goal of increasing the understanding and beneficial use of medical instrumentation.
AAMI is the primary source of consensus and timely information on medical instrumentation and technology.
- AAMI is the primary resource for the industry, the professions, and government for national and international standards.
- AAMI provides multidisciplinary leadership and programs that enhance the ability of the professions, healthcare institutions, and industry to understand, develop, manage, and use medical instrumentation and related technologies safely and effectively.
- AAMI provides a unique and critical forum for members who cover a complete range of interests, from clinical and biomedical engineers and technicians, physicians, nurses, and hospital administrators, to educators and researchers, manufacturers, distributors, government representatives and other healthcare professionals with an interest in medical devices. These diverse groups have been instrumental in making AAMI the leading source of essential information on medical devices and equipment since 1967.
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).
ANSI
The American National Standards Institute (ANSI) coordinates the development and use of voluntary consensus standards in the United States and represents the needs and views of U.S. stakeholders in standardization forums around the globe.
ANSI facilitates the development of voluntary consensus standards. Accreditation by ANSI signifies that standards developing organizations adhere to the Institute's essential requirements for openness, balance, consensus and due process during the development of American National Standards.
ANSI provides a vital link between standards and products, services and systems. ANSI directly accredits the certifiers of a broad range of products and personnel. Through the ANSI-ASQ National Accreditation Board (ANAB), accreditation is available for the certifiers of environmental management systems such as ISO 14001, along with other systems ranging from quality and information systems security to food safety and occupational health and safety. More recently, this accreditation portfolio has been expanded to include testing and calibration laboratories, reference material producers and inspection bodies.
ANSI speaks as the voice of the nation’s standards and conformity assessment community. The Institute is the official U.S. member of the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC). ANSI is also a member of the International Accreditation Forum and numerous regional standards and conformity assessment organizations. ANSI’s work with these organizations helps to ensure that U.S. views are well represented during the development of globally relevant standards and the related compliance programs.
ANSI represents the interests of more than 125,000 companies and 3.5 million professionals worldwide. The Institute empowers its members with the information, voice and influence they need to influence the standardization decisions affecting their business.
ASTM
ASTM International is one of the largest voluntary standards development organizations in the world - a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.
ASTM International, originally known as the American Society for Testing and Materials (ASTM), was formed over a century ago, when a forward-thinking group of engineers and scientists got together to address frequent rail breaks in the burgeoning railroad industry. Their work led to standardization on the steel used in rail construction, ultimately improving railroad safety for the public. As the century progressed and new industrial, governmental and environmental developments created new standardization requirements, ASTM answered the call with consensus standards that have made products and services safer, better and more cost-effective. The proud tradition and forward vision that started in 1898 is still the hallmark of ASTM International.
Today, ASTM continues to play a leadership role in addressing the standardization needs of the global marketplace. Known for its best in class practices for standards development and delivery, ASTM is at the forefront in the use of innovative technology to help its members do standards development work, while also increasing the accessibility of ASTM International standards to the world.
ASTM continues to be the standards forum of choice of a diverse range of industries that come together under the ASTM umbrella to solve standardization challenges. In recent years, stakeholders involved in issues ranging from safety in recreational aviation, to fiber optic cable installations in underground utilities, to homeland security, have come together under ASTM to set consensus standards for their industries.
Standards developed at ASTM are the work of over 30,000 ASTM members. These technical experts represent producers, users, consumers, government and academia from over 100 countries. Participation in ASTM International is open to all with a material interest, anywhere in the world.
DIN
DIN, the German Institute for Standardization, develops norms and standards as a service to industry, the state and society as a whole. A registered non-profit association, DIN has been based in Berlin since 1917.
DIN's primary task is to work closely with its stakeholders to develop consensus-based standards that meet market requirements. Some 26,000 experts contribute their skills and experience to the standardization process. By agreement with the German Federal Government, DIN is the acknowledged national standards body that represents German interests in European and international standards organizations. Ninety percent of the standards work now carried out by DIN is international in nature.
Every year DIN develops around 2,600 standards, draft standards and specifications with the help of 28,500 external experts and 380 staff members working within 77 standards committees.