HOME >> BIOLOGY >> NEWS
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.


'"/>

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


Page: 1

Related biology news :

1. Florida Tech earns $50,000 grant to create coral database
2. Computer database being developed at Temple will allow for better inventory of chemicals
3. New database to help develop AIDS drugs
4. Confidentiality of genetic databases questioned by Stanford researchers
5. Nations plant database falling behind, survey shows
6. Paleofire database puts fire-scar and charcoal data online
7. Thorough, searchable database of human proteins unveiled
8. Conservation Management Institute developing national database for chronic wasting disease
9. Funding for global protein database
10. New public-domain database could advance human computer interaction through sound
11. Geologists develop new database using GIS for study of evolution of continents

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:4/15/2016)... 2016  A new partnership announced today will ... decisions in a fraction of the time it ... high-value life insurance policies to consumers without requiring ... Force Diagnostics, rapid testing (A1C, Cotinine and HIV) ... pressure, weight, pulse, BMI, and activity data) available ...
(Date:3/31/2016)...  Genomics firm Nabsys has completed a financial  restructuring ... , M.D., who returned to the company in October ... team, including Chief Technology Officer, John Oliver , ... and Vice President of Software and Informatics, Michael ... Dr. Bready served as CEO of Nabsys from 2005-2014 ...
(Date:3/21/2016)... , March 22, 2016 ... recognition with passcodes for superior security   ... a leading provider of secure digital communications services, today ... biometric technology and offer enterprise customers, particularly those in ... facial recognition and voice authentication within a mobile app, ...
Breaking Biology News(10 mins):
(Date:4/29/2016)... ... April 29, 2016 , ... ... medicine, is excited to announce the launch of the Proove Health Foundation ... volunteerism, and education to promote the use of personalized medicine for tackling the ...
(Date:4/29/2016)... , ... April 29, 2016 , ... ... necessary fundamentals to transform technology into a viable company, CereScan’s CEO, John Kelley, ... Mr. Kelley, a recognized leader and mentor in the Denver area business community, ...
(Date:4/29/2016)... Italy , April 29, 2016 ... 5.11, the latest update to its industry-leading treatment planning ... shown that Monaco version 5.11 ... can now attain calculation speeds up to four times ... . With the industry,s gold standard ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... Connecticut's innovative, growing companies, today announced the launch of VentureClash , a ... companies. , “VentureClash looks to attract the best early-stage companies here ...
Breaking Biology Technology:
Cached News: