60601 Symbol Issue - CE Mark Symbol and Size Requirements

We are in the middle of CE mark certification. We are using a symbol for power on/off that is unique to our product. There is no symbol for outr product We a0 our registar not using a symbol from 60601. Many years ag0 “Approved” the symbol. With our current design if we use the symbols in 60601, each symbol will be 3-4mm in diameter, we consider this unsafe. Is there any where documented that deviatins are allowed, if we can document why we need to deviate.

You can always deviate from standards, as they are not compulsory. But you has to document, in your risk management file, why you deviated and assure that the level of safety is the same as it would be if you use the standard. Anyway, different symbols are ok as long as you make an assessment of it´s use (usability) and inform the operator (in the instructions for use, for example) and declare the residual risk, if any (risk management).

BUT, i would not advise using different symbols for common known actions, such as power on/off. That´s because these kind os symbols are "common knowledge" and operators tend to expect these in equipment for these common actions. The results from the usability testing and risk management should tell you if using a different symbol for a common known action is a problem.