Official CTL Decision on CB Certification of OFF/ITE/AV Equipment under the IEC 60601-1 Standard

An official CTL decision has been published on the IECEE website regarding the CB certification of OFF/ITE/AV equipment under the IEC 60601-1 standard (e.g., monitors, distribution units, etc.).

Reference: IECEE Decision DSH 2208A

Since these devices are now considered outside the scope of the IEC 60601-1 definition, direct CB certification under this medical standard is no longer possible. Instead, such products must first be tested and certified according to IEC 62368-1. Following this, an additional evaluation based on IEC 60601-1 can be performed. Furthermore, a note will be included on the CB certificate indicating that the product has also been tested and evaluated according to the IEC 60601-1 standard.

More information:

Janez Vidmar

E-mail: janez.vidmar@siq.si  

Tel.: +386 1 4778 262