DEKRA Testing and Certification S.A.U accredited to certify medical devices under the IECEE CB Scheme

DEKRA Testing and Certification S.A.U. has added a new category of products to its accreditation as a Testing Laboratory (CBTL) for the IECEE CB Scheme, which now also includes electrical equipment for medical use. This certification program, operated by the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE), is designed to ensure the safety of electrical and electronic components, equipment and products. With the scope extension for this program, customers can also count on DEKRA to test and certify products listed in the MED category of the IECEE CB Scheme, which includes medical electrical devices such as electrocardiographs, patient monitors, pulsioximeters, nerve and muscle stimulators, ultrasound equipment, endoscopy equipment, or surgical, cosmetic, therapeutic and diagnostic laser equipment, among others.

“Nowadays, electrical equipment for medical purposes is increasing and becoming more necessary and extended. To support our clients in the evaluation and certification of this type of product, we are pleased to extend our accreditation as a testing laboratory for the IECEE CB scheme, incorporating the category of electromedical equipment. In addition, we recently added the HOUS category, which includes household appliances and similar devices, so the services we offer our clients for this certification program have been significantly extended”, said Rafael González, Product Safety Testing Laboratory Head at DEKRA Testing and Certification S.A.U.

By certifying products with the IECEE CB Scheme, customers can facilitate the market access of their products, since this certification program recognizes the test report and certificates of a product in different locations when is issued by a certification body of IECEE. Therefore, manufacturers don't need to duplicate testing for each market where they will commercialize their products, since test reports and certificates are accepted and recognized in 54 countries by any of the 92 certification bodies members of this program.

In addition to the IECEE CB Scheme certification program, DEKRA supports customers by offering a wide scope of product safety testing and certification services for electrical products, such as testing according to European and international standards to access worldwide schemes; i.e. cDEKRAus mark for North America and Canada, or the DEKRA Safety Mark that increase the product safety level monitoring the production, among others services.

For more information about these services or to request a quote, please contact DEKRA.