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New database aids medical device exporters

A new international database has been released that identifies measurement procedures and materials that will help U.S. makers of in vitro diagnostic (IVD) medical devices ensure that their products comply with European Union requirements. Staff from the National Institute of Standards and Technology (NIST) played a key role in the establishment and leadership of the international committee that produced the database.

Use of the standards identified in the database should facilitate worldwide comparability of clinical measurements, which, in turn, should improve patient care, reduce technical barriers to trade and reduce costs for both IVD manufacturers and medical testing in general.

The European Union recently issued new regulations on the sale of in-vitro diagnostic (IVD) medical devices such as those used to measure blood levels of glucose and cholesterol. The EU "Directive" requires that values assigned to commercial standards used for calibrating such devices be traceable to appropriate "higher order" measurement procedures and/or certified reference materials, such as those from internationally recognized national metrology institutes like NIST.

To assist the U.S. IVD industry, which has more than 60 percent of the European market, NIST provided leadership for the international working group charged with selecting the list of procedures and materials that can be used to demonstrate compliance with the EU Directive and with similar requirements that might be imposed by other regions.

The new database contains approximately 100 Reference Measurement Procedures, including 30 developed and maintained by NIST. The database lists 96 approved reference materials; NIST is the source for 72 of these.

For more information, see www.cstl.nist.gov/nist839/jctlm.htm.


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Contact: Laura Ost
laura.ost@nist.gov
301-975-4034
National Institute of Standards and Technology (NIST)
9-Apr-2004


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