Advertisement
Medical professionals can now access 1,300+ medical device standards from one single database developed jointly by ANSI, the Association for the Advancement of Medical Instrumentation (AAMI), ASTM International, and the German Institute for Standardization (DIN).
Advertisement
This new Medical Device Standards Portal provides a single, user-friendly source for critical documents from AAMI, ASTM, DIN, the U.S. Food and Drug Administration (FDA), the International Electrotechnical Commission (IEC), and the International Organization for Standardization (ISO), as well as applicable European regulations.
All documents are available fully indexed and in a .pdf format that is easily downloaded. By 2010, it is anticipated that documents will also be available in an HTML format, providing subscribers with more robust functionality.
The Medical Device Portal arms medical device professionals with a powerful information management system that will enable users to:
The database is powered by Citation Technologies Inc., a world leader in the field of online document management solutions. Earlier this year, ANSI and Citation announced an agreement to provide 17,765 standards developed by the International Organization for Standardization (ISO) on the citation(TM) platform The Institute also offers ANSI iPackages, which includes six collections from the ISO 14000 series of environmental management system (EMS) standards, through citation(TM).
To learn more about the Medical Device Standards Portal, simply download the online features and benefits fact sheet or contact Mark Brown, ANSI (phone: 212-642-4935; [email protected]) or Jim S. Thomas, ASTM International (phone: 215-431-2411; [email protected]).
About ANSI (www.ansi.org)
The American National Standards Institute (ANSI) is a private non-profit organization whose mission is to enhance U.S. global competitiveness and the American quality of life by promoting, facilitating, and safeguarding the integrity of the voluntary standardization and conformity assessment system. Its membership is comprised of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations. The Institute represents the diverse interests of more than 125,000 companies and organizations and 3.5 million professionals worldwide.
The Institute is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC), and is a U.S. representative to the International Accreditation Forum (IAF).
About AAMI (www.aami.org)
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.
About ASTM International (www.astm.org)
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's 13,000+ standards have an important role in the information infrastructure that guides design, manufacturing, and trade in the global economy.
About DIN (www.din.de)
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.
-- Investigate: Access and link directly between 1,300+ ASTM, ISO, IEC, AAMI, EN (DIN), FDA, and European regulations from one source -- Monitor: Receive notifications when standards are updated and compare revisions with color-coded highlights denoting changes -- Annotate: Integrate company practices and polices into the standards, preserving and passing on expertise -- Collaborate: Add comments directly into the standards and share analysis with others
SOURCE American National Standards Institute
