Certifications needed for ESB

[lgs-wtk]

Hello !

We are planning to use ESB to communicate in-between nRF52 devices in a public environment.
NB: our product only embeds the ESB stack - no bluetooth nor BLE tasked is performed by the nRF52 device.
- The product will be distributed worldwide.
- Wifi devices will be in proximity
- Bluetooth and BLE devices will be in proximity


Apart from the usual radio certification, is there any other certification that I must go through to ensure: 
1. Bluetooth compatibility (not perturbate / not be perturbated by)
2. BLE compatibility (not perturbate / not be perturbated by)
3. Wifi 2.4GHz compatibility (not perturbate / not be perturbated by)

Also, do you have any knowledge about some specific certification related to radio in a medical environment ?

Regards,

Laurent

[Simonr]

Hi

The only real difference between ESB and BLE as far as I know is the frequency deviation between symbols (radio modulation mode). The deviation is lower in ESB, so the 1MBPS nRF radio mode will likely not pass the FCC 15.247 6dB bandwith test due to a change in the test specification by FCC some years ago. If you make sure to always use 2Mbps this should be fine though, if not it needs to be certified under 15.249.

Regarding medical certifications, I'm aware of the FDA classification required in the U.S: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device and the EMA regulatory in EU: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices 

Best regards,

Simon

[lgs-wtk]

Hi Simon,

Thank you for your answer.

I would like a final confirmation :
Is there a certification specifically linked to ESB or should we consider that we must pass the certifications usually linked to BLE to be compliant ?

Best regards,

Laurent