ANSI - American National Standards Institute
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New Database Provides Centralized Information for Medical Device Professionals

New York, Nov 13, 2009

The American National Standards Institute (ANSI) has joined forces with three of the biggest names in standards 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 ANSI, the Association for the Advancement of Medical Instrumentation (AAMI), ASTM International, and the German Institute for Standardization (DIN).

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:

  • 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

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™ platform The Institute also offers ANSI iPackages, which includes six collections from the ISO 14000 series of environmental management system (EMS) standards, through citation™.

To learn more about the Medical Device Standards Portal, contact Mark Brown, ANSI (; 212-642-4935).

 Homeland Defense and Security Standardization Collaborative