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ASTM International

FDA Compliance

Product News: New Database for Medical Device Professionals Unveiled

AAMI, ANSI, ASTM International, and DIN join forces to provide medical device portal.

Published: Wednesday, September 9, 2009 - 16:27

(ASTM: West Conshohocken, PA) -- 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 more than 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:

  • Search and link between all of the standards
  • Compare revisions via color-coded highlighting
  • Add comments and attachments directly in the standards and share with others
  • Integrate company practices alongside the standards and more

The database is powered by Citation Technologies Inc., a provider of online document management solutions.

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ASTM International

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence within R&D, product testing, quality systems, and commercial transactions. ASTM International meets the World Trade Organization principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance, and transparency.