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Dear members,
My company wants to develop a medical device class 1 (external of the body, no risks for health) which includes a remote control. The action of the remote control is to send orders to a controler which change the position of the valve of an hydraulic circuit. The power is very low as the remote control is at a distance of maximum 2 meters from the controler. Frequency is not yet defined 2.4GHz or other tbd.
I am looking for which standards should apply to the radio part of the equipment (remote control + controler radio interface).
Please can you help to clarify following info :
- is this equipment considered as ISM (industrial scientific medical) ? I am confused about which product is ISM, which not.
- for US which shall apply FCC part 15 or part 18 ?
- for Europe : EN55011 ? other ?
thanks for the infos, best regards.
Francis
My company wants to develop a medical device class 1 (external of the body, no risks for health) which includes a remote control. The action of the remote control is to send orders to a controler which change the position of the valve of an hydraulic circuit. The power is very low as the remote control is at a distance of maximum 2 meters from the controler. Frequency is not yet defined 2.4GHz or other tbd.
I am looking for which standards should apply to the radio part of the equipment (remote control + controler radio interface).
Please can you help to clarify following info :
- is this equipment considered as ISM (industrial scientific medical) ? I am confused about which product is ISM, which not.
- for US which shall apply FCC part 15 or part 18 ?
- for Europe : EN55011 ? other ?
thanks for the infos, best regards.
Francis