Press Release Summary:
ASTM International has jointly developed, alongside AAMI, ANSI, and DIN, the Medical Device Standards Portal, which provides access to medical device standards and related information. Access to 1,300+ standards as well as critical documents from AAMI, ASTM, DIN, U.S. FDA, IEC, ISO, and various European regulations is available from one database. Upon initial launch, documents will be fully indexed and in PDF format. By year-end, they are also anticipated to be available in HTML format.
Original Press Release:
New Database from AAMI, ANSI, ASTM International and DIN Provides Centralized Source of Information for Medical Device Professionals
W. CONSHOHOCKEN, Pa., September 8, 2009-Four of the biggest names in standards have joined forces to develop an unprecedented resource for medical device standards and related information.
Medical professionals can now access 1,300+ medical device standards from one single database developed jointly by the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International and the German Institute for Standardization (DIN).
This new Medical Device Standards Portal is a user-friendly single source for critical documents from AAMI, ASTM, DIN, the U.S. Food and Drug Administration (FDA), the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO) and various European regulations.
Upon initial launch, all documents will be available fully indexed and in a PDF format that can be easily downloaded. By year-end, it is anticipated that all documents will also be available in an HTML format, providing subscribers with more robust functionality.
The Medical Device Portal will arm 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. Other portals running under the citation® platform include its flagship product, CyberRegs® a comprehensive collection of regulatory information of interest to environmental, health and safety, and transportation compliance officers. Many other organizations also present their intellectual property on subscription Web sites powered by citation.
To learn more about the Medical Device Standards Portal and to see an online demonstration, visit www.medicaldevicestandards.com or contact Jim S. Thomas, ASTM International, West Conshohocken, Pa. (phone: 215-431-2411; firstname.lastname@example.org); or Mark Brown, ANSI, New York, N.Y. (phone: 212-642-4935; email@example.com).
Carla Falco, ASTM International
100 Barr Harbor Drive, W. Conshohocken, PA 19428
610-832-9605; firstname.lastname@example.org, www.astm.org
The Association for the Advancement of Medical Instrumentation (AAMI), a nonprofit organization founded in 1967, is a unique alliance of more than 6,000 members from around the world united by the common goal of increasing the understanding and beneficial use of medical instrumentation through effective standards, educational programs, and publications.
AAMI is the primary source of consensus and timely information on medical instrumentation and technology.
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).
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.
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.