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Medical CB Scheme Approvals
The IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components, also known as the CB Scheme, is operated by the IECEE. It is based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval at national level.
The CB Scheme is intended to reduce obstacles to international trade which arise from having to meet different national certification or approval criteria.
The operating units of the CB Scheme are the National Certification Bodies (NCBs). TÜV Rheinland is such an NCB. NCBs employ testing laboratories known as CB Testing Laboratories (CBTLs). TÜV Rheinland scope does cover the recently published IEC 60601:2005-1 standard. The CB Scheme is based on the use of CB Test Certificates, which provide evidence that representative specimens of a product have successfully passed tests to show compliance with the requirements of the relevant IEC standard. A supplementary report providing evidence of compliance with declared national differences, needed in order to obtain national certification or approval, may also be attached to the CB Test Report.
TÜV Rheinland. provides the most comprehensive set of product-testing services for the local market. Our expertise covers a wide range of international (IEC and ISO) and national (EN, UL, CSA, JIS, etc.) standards applicable to various medical devices, from the simple thermometer to sophisticated medical-imaging systems and laser-treatment equipment.
| Standard | Last Date for Evalutation | Last Date for Production | Sussessor |
| EN 60601-1:1990 + A1 +A2 +A13 | Date not published | Date not published |
EN 60601-1:2006 |
| EN 60601-1:2006 | - | - |
none |
According to Health Canada CAN/CSA-C22.2 No. 60601-1-08 will replace CAN/CSA-C22.2 No.601.1-M90 (R2005). Health Canada intends to fully recognize the third edition effective June 1, 2012.
