Medical Device Database offers access to 1,300 standards.
Press Release Summary:
Developed jointly by ANSI, AAMI, ASTM International, and DIN, Medical Device Standards Portal provides single source for critical documents from AAMI, ASTM DIN, US FDA, IEC, and ISO, as well as applicable European regulations. All documents are available fully indexed and in .pdf format. Users can add comments directly into standards, share analysis with others, receive notifications when standards are updated, and compare revisions with color-coded highlights denoting changes.
Original Press Release:
New Database Provides Centralized Information for Medical Device Professionals
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(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 (mbrown@ansi.org; 212-642-4935).
