UL Expands CBTL Status to include IEC 60601-1 3rd edition
AUCKLAND, NEW ZEALAND November 7, 2012 - UL International New Zealand Limited Auckland, a subsidiary of UL (Underwriters Laboratories), a world leader in advancing safety, has been successful in expanding recognition under the IECEE CB Scheme as a Certification Body Test Lab (CBTL) for IEC 60601-1 3rd edition.
UL International New Zealand Limited Auckland is a well-established CB Test Laboratory in Medical (MED) and Household Appliances (HOUS) categories; providing enhanced global market access in conjunction with UL's National Certification Body (NCB) UL Demko to issue CB test certificates (CBTC) accepted by other CB Scheme members around the world to issue local certification marks.
The expansion of CBTL scope to include the 3rd edition of IEC 60601-1, together with IEC 60601-1-11 for medical electrical equipment and medical electrical systems used in the home healthcare environment reinforces UL's recognition of the importance of the medical device industry in Australia and New Zealand and ensures UL continues to provide a high quality and recognized pathway to international compliance.
"We understand that the local industry needs a trusted, local resource for testing and certification," said Doug Johnson, Vice President and General Manager, Australasia. "Now that UL has expanded CBTL status in Auckland to include Edition 3 of IEC 60601-1 together with the new standard for the home healthcare environment, local manufacturers forming part of our key client base can continue to work with our competent engineers and have their compliance needs fulfilled in the local time zone."
IEC 60601-1 is the internationally harmonized safety standard for electromedical equipment. In order to receive approval in global markets, manufacturers of higher risk medical devices must demonstrate their safety and effectiveness through the submission of test data. Many of the regulators around the world recognize the IEC 60601-1 series of standards as a means of demonstrating device safety.
"The medical device industry is extremely competitive and the New Zealand market has consistently been a region of innovation in medical devices" said Anil Patel, GM and Vice President, UL Life & Health Business Unit. "By investing in CB Scheme certification, UL is supporting the ability of local manufacturers to compete on a global level."
To learn more about UL's full testing, certification and advisory services to support global market access, visit http://www.ul.com/