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UL Italy Achieves CBTL Status for Medical and Laboratory Equipment

Medical device, lab equipment and IVD manufacturers can now take advantage of a local, high quality and recognized path to international compliance.

Women doctors discussing research

April 4, 2022

The expansion of the scope of UL’s CB test laboratory in Italy includes the second and third editions of IEC 60601-1 and IEC 61010-1 standards with amendments and several particular standards for medical electrical equipment, laboratory equipment and in-vitro diagnostic (IVD). This achievement reinforces the importance of the health sciences industries in Southern Europe and helps ensure UL continues to provide a high quality and recognized pathway to international compliance. Medical device, laboratory equipment and IVD manufacturers in the region can now take full advantage of UL’s local test and advisory service capabilities to support global regulatory approvals directly through the Italian 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 and measurement equipment. 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 regulators around the world recognize the IEC 60601-1 and IEC 61010-1 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, such as 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 that contribute to its ability to be a respected technical voice within the IEC community.


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