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American National Standards Institute ANSI  |  11/30/2009

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Database Provides Centralized Info for Medical Device Professionals

Thousands of medical device standards in a single click.

(ANSI: New York) -- 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 more than 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).

The new Medical Device Standards Portal provides 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), 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 Standards Portal arms medical device professionals with a powerful information management system that will enable users to:

  • Investigate. Access and link directly between more than 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, visit www.medicaldevicestandards.com.

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American National Standards Institute ANSI’s picture

American National Standards Institute ANSI

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to ensure the safety and health of consumers and the protection of the environment. The institute oversees the creation, promulgation, and use of thousands of norms and guidelines that directly impact businesses in nearly every sector: from acoustical devices to construction equipment, from dairy and livestock production to energy distribution, and many more. Visit www.ansi.org.