New database for U.S. makers of in vitro diagnostic (IVD) medical devices

Apr 9 2004

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 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.