May 5, 2016
MINNEAPOLIS. Minn., May 5, 2016 – UL (Underwriters Laboratories), a global safety science organization, announced today it continues to be 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]. UL in total issued twice the amount of MED CB Test Certificates than its closest competitor in 2015[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. In 2015, the MED category represented 4.6 percent of the overall IECEE Certificates issued for all categories, or approximately 4,026 certificates. Overall, the number of CB certificates issued by all NCBs in the MED category slightly decreased from 2014[iv].
“Striving to be in the best position to help our customers bring innovative products to markets and demonstrate compliance to regulators, our medical industry-dedicated thought leaders maintain focus on safety science principles, compliance issues and remain active members of industry standards writing and technical committees“ said Deborah Jennings-Conner, global Director of Operations for UL’s Health Sciences division. “Our medical testing and certification team has over 800 years of collective experience with an average of 9 years’ experience per engineer which makes UL uniquely positioned to help customers achieve compliance in their target markets.”
In 2015, UL also widened its lead in the MEAS category, for products tested to IEC 61010, the standard for Laboratory, Test and Measurement Equipment. The MEAS category represents approximately 2% of the overall CB Scheme Test Certificates issued in 2015.
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 actively participates in IEC standards technical committees which contribute to its ability to be a respected technical voice within the IEC community.
[i]Comparison and analysis of 2002-2015 reports http://www.iecee.org/cbscheme/html/cbstats.htm
[ii] Analysis of report: IECEE-CMC/1687A/INF - Result of the Questionnaire regarding 2015 Statistics on Issued CB Test Certificates http://www.iecee.org/cbscheme/pdf/cmc1687ainf.pdf
[iii] About the CB Scheme http://iecee.org/cbscheme/pdf/cbfunct.pdf June 4, 2015
[iv] Analysis of 2015 data http://www.iecee.org/cbscheme/pdf/cmc1689inf.pdf
[v]About the CB Scheme http://iecee.org/cbscheme/pdf/cbfunct.pdf