Manufacturers of active medical devices (electrically powered devices, or electromedical devices) are required to have their devices tested by a testing laboratory to certify compliance with the 60601 series of standards. -1 (electrical safety and electromagnetic compatibility).
To place these active devices on the market outside the European Union, the manufacturer will be required to provide a test report known as the “CB Scheme.”
What is the CB Scheme?
The CB Scheme, or Certification Body Scheme, also known as the OC System (for Certification Body) in French is an international certification system established by the IECEE (IEC System for Conformity Testing and Certification of Electrical and Electronic Equipment). It is based on the mutual acceptance of test reports and certificates concerning the safety of electrical and electronic components, equipment, and products. This system allows companies to obtain multiple international certification marks (CSA, UL, etc.) through a single round of testing.
When a manufacturer has its electromedical device tested at a testing laboratory and wishes to enter markets outside the EU, the testing laboratory must therefore be part of a Certification Body Scheme and is therefore qualified to issue a test report in the CB Scheme format. This test report format is recognized in more than 54 countries and thus facilitates market access, particularly to the U.S. market.
When requesting a quote from the testing laboratory, the manufacturer should be sure to mention this requirement. Issuing a test report in the CB Scheme format takes longer and is more expensive; these constraints should be taken into account when planning product development.