July 11, 2016
The UL Poland team successfully completed the IECEE audit in June with no findings and is now a CB Test Laboratory (CBTL) under the Medical (MED) and Laboratory (MEAS) categories under the IECEE CB Scheme.
The expansion of UL Poland’s CBTL scope includes the 2nd and 3rd editions of IEC 60601-1 and IEC 61010-1 with Amendments and several particular standards for medical electrical equipment and laboratory equipment. This reinforces UL’s recognition of the importance of the health sciences industries in Eastern Europe and helps ensure UL continues to provide a high quality and recognized pathway to international compliance. Medical device and laboratory equipment manufacturers in that region can now take full advantage of UL local test and advisory service capabilities to support global regulatory approvals directly through the Poland office.
IEC 60601-1 is the internationally harmonized safety standard for electromedical equipment and IEC 61010-1 is the internationally harmonized standard for Laboratory and Test & Measurement Equipment. In order to receive approval in global markets, manufacturers of higher risk medical devices and diagnostic laboratory equipment 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 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.
UL actively participates in IEC standards technical committees which contribute to its ability to be a respected technical voice within the IEC community.