July 16, 2015
NORTHBROOK, Ill. July 14, 2015 – UL (Underwriters Laboratories), a global safety science organization, announced today it remains the global market leader in issuing IEC System of Conformity Assessment for Electrotechnical Equipment and Components (IECEE) Certification Body (CB) Test Certificates for medical electrical devices (MED). UL, including its global subsidiaries, has been the overall leader in the MED category since at least 2002[i] and in 2014 saw its market share increase significantly over the closest competitor including its combined subsidiaries. UL in total issued twice the amount of MED CB Test Certificates than its closest competitor in 2014[ii].
According to IECEE, CB Test Certificates “attest that the product samples have successfully passed the test conditions and are in compliance with the requirements in the relevant IEC (International Electrotechnical Commission) Standard(s).”[iii] For the “MED” category, the relevant standards include the recognized IEC 60601-1 series of standards. The MED category represents 5 percent of the overall IECEE Certificates issued for all categories, or approximately 4,000 certificates. Overall, the number of CB certificates issued by all NCBs in the MED category increased 1.8 percent from 2013[iv].
“To deliver UL’s safety mission, our engineers apply their safety science principles and compliance knowledge so they are in the best position to support challenging technical questions,” said Deborah Jennings-Conner, global director of operations for UL’s Health Sciences division. “Because the medical industry is regulated, the test report data is also being scrutinized by regulatory bodies around the world. It is our prerogative to support our customers through this process and with other services that enable global regulatory approvals.”
The IECEE established the CB Scheme to provide a means for the mutual acceptance of CB Test Certificates and CB Test Reports among participating safety certification organizations, including UL, for the purpose of obtaining national certification or marks. The CB Scheme is an international network made up of product certification organizations in more than 50 countries around the world.[v]
UL actively participates in IEC standards technical committees which contribute to its ability to be a respected technical voice within the IEC community.
UL is a premier global independent safety science company that has championed progress for more than 120 years. Its nearly 11,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, testing, inspection, advisory and education services, visit http://www.UL.com.
[i]Comparison and analysis of 2002-2014 reports http://www.iecee.org/cbscheme/html/cbstats.htm
[ii] Analysis of report: IECEE-CMC/1556/INF - Result of the Questionnaire regarding 2014 Statistics on Issued CB Test Certificates http://www.iecee.org/cbscheme/pdf/cmc1558inf.pdf
[iii] About the CB Scheme http://iecee.org/cbscheme/pdf/cbfunct.pdf June 4, 2015
[iv] Analysis of 2014 data http://www.iecee.org/cbscheme/pdf/cmc1556inf.pdf
[v]About the CB Scheme http://iecee.org/cbscheme/pdf/cbfunct.pdf