Do I need a new RF CERTIFICATION of the STM32WB5MMG on a custom pcb with body distance LESS than 20cm?

[BGeig.3]

In the datasheet of the STM32WB5MMG Module is written

The module antenna must be installed to meet the RF exposure compliance separation distance of “20 cm�? and any additional testing and authorization processes as required.

in the sections FCC and ISED certification.

In the application we are pursuing, the module is to be located on a custom pcb, which - surrounded by a plastic housing - is to be worn directly on the skin, like a wearable.

This means that the minimum distance of 20cm to the body is not maintained.

This raises the following questions:

1. Is a new RF certification necessary to confirm compliance with the RF radiation exposure requirements directly on the skin?

2. Why is the 20cm distance not mentioned in the CE certification section?

2.1 Is the distance to the body irrelevant for the validity of the CE certification (EU)?

And one additional question, in case someone knows:

• How much does certification by a testing laboratory (CE, FCC, ISED, ...) cost (approx.)?

Thank you very much for any informations about RF certifications :)

Regards,

Benjamin

[David MOTSHAGEN · Accepted solution]

Hello Benjamin.

The distance between the device and the human body does not affect any of the certifications we obtained for the STM32WB5M. You should not need to redo the entire certification process for all the regions.

However, as manufacturer you need to make sure that your product meets legal requirements for the markets you sell to.

We advise you to discuss this with a testing lab (Veritas, Dekra, TUV or other) and provide them with the certifications already obtained by ST, and specifically the EN 62311 for the EU. They will be able to say which additional tests and certifications are needed.

Regards,

David.