MINNEAPOLIS, May 5, 2016 /PRNewswire/ -- 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 2002i. UL in total issued twice the amount of
MED CB Test Certificates than its closest competitor in
2015ii.
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
2014iv.
"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.
About UL
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, training
and education services, visit http://www.UL.com.
iComparison 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
vAbout the CB Scheme
http://iecee.org/cbscheme/pdf/cbfunct.pdf
Contact: Tara Kambeitz
Global Marketing Manager
UL LLC
T: +1 (360) 817-5610
E: Tara.L.Kambeitz@UL.com
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SOURCE UL