AAMI, ANSI, ASTM, DIN Develop Medical Device Standard Database
October 1, 2009 // Published as a news service by IHS
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The Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International and Deutsches Institut für Normung (DIN) teamed to create a medical device standards database.
The Medical Device Standards Portal includes 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, the documents will be indexed and in a downloadable PDF format. The documents should be available in an HTML format by year-end.
The portal will enable users to:
- Search and link between 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.
Source: ASTM International.