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:2/5/2016)... http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has ... Facial Recognition Market 2016-2020" report to ... has announced the addition of the ... to their offering. --> Research ... the addition of the "Global Facial ...
(Date:2/3/2016)... Sweden , February 4, 2016 --> ... amounted to SEK 1,351.5 M (105.0), up 1,187% compared with fourth quarter ... profit amounted to SEK 517.6 M (loss: 30.0). Earnings per ... operating activities was SEK 537.4 M (neg: 74.7). , ... , Revenues amounted to SEK 2,900.5 M (233.6), up 1,142% compared ...
(Date:2/3/2016)... 3, 2016 Vigilant Solutions announces today that ... Missouri solved two recent hit-and-run ... data from Vigilant Solutions. Brian Wenberg ... the victim was walking out of a convenience store and witnessed an elderly ... his vehicle, striking his vehicle and leaving the scene.  ...
Breaking Biology News(10 mins):
(Date:2/10/2016)... -- The Maryland House of Delegates and House Speaker ... Maryland School of Medicine Dean E. Albert Reece ... System President and CEO Robert Chrencik , MBA, ... given to the public by the leader of the ... and Mr. Chrencik for their contributions to our statewide ...
(Date:2/10/2016)... Tarrytown, New York, and New York, New York (PRWEB) , ... ... ... Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) today announced that ... discover and develop new vaccines and immunotherapies for infectious diseases and cancer. ...
(Date:2/10/2016)... 10, 2016  Matchbook, Inc., a company specializing ... biotech companies, announced today the appointment of ... Jim brings nearly 25 years of experience in ... spent nearly two decades in executive level roles ... at Genzyme and, most recently headed global logistics ...
(Date:2/10/2016)... ... , ... LATHAM, NEW YORK... Marktech Optoelectronics will feature their new ... San Francisco’s Moscone Center from February 16-18, 2016, and at the healthcare-focused BiOS Expo ... PIN diode standard packages feature a TO-46 metal can with active areas of 1.0mm ...
Breaking Biology Technology:
Cached News: