Remote Control for Class I Medical Device

6

6F_21

#1
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
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
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
Can someone help Francis?

Thank you!

Stijloor.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
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
Hi,

Can't help you much with the above, but for Europe you better also consider IEC 60601, the part that deals with EMC (can't remember the number at the moment).

Good luck,
Ronen.
 
6

6F_21

#4
Dear Members,

Thanks for the answers, very nice of you.
I think that my first question was maybe not clear enough. and I'd like to put it differently :

Is a standard remote control used in a medical device considered as an ISM device ? example : a bluetooth remote control.

I ask this question because I read sometime that ISM is only relative to application of RF for heating or soldering... but not including communication.

From this website : (18.107)
access.gpo.gov/nara/cfr/waisidx_07/47cfr18_07.html
(c) Industrial, scientific, and medical (ISM) equipment. Equipment or appliances designed to generate and use locally RF energy for industrial, scientific, medical, domestic or similar purposes, excluding applications in the field of telecommunication. Typical ISM applications are the production of physical, biological, or chemical effects such as heating, ionization of gases, mechanical vibrations, hair removal and acceleration of charged particles.

From this, I understand that a remote control is not an ISM device although it is included in a medical device. Right ?

On the other hand, according to wikipedia ISM_band
the ISM frequencies are commonly used for communication. (bluetooth, RFID..)

I think there is a confusion, right ?
If this is true a remote control in a medical device can use the ISM frequencies but is not an ISM device. So it is regulated by FCC part 15 and not part 18.

If anyone could confirm ? Thanks a lot.

Francis
 
N

nikolaos

#5
Not sure to help you, here are some my considerations:
A medical device with a remote RF control falls under the medical and R&TTE directives. This means IEC/EN 60601-1, IEC/EN60601-1-2, CISPR 11, 47 CFR Part 15 subpart B (FCC) as a medical device and
Part 15 subpart C ( FCC), EN301 489, EN60950-1 under R&TTE.
Hope this helps
 

bio_subbu

Super Moderator
#6
Dear Members,

Thanks for the answers, very nice of you.
I think that my first question was maybe not clear enough. and I'd like to put it differently :

Is a standard remote control used in a medical device considered as an ISM device ? example : a bluetooth remote control.

I ask this question because I read sometime that ISM is only relative to application of RF for heating or soldering... but not including communication.

From this website : (18.107)
access.gpo.gov/nara/cfr/waisidx_07/47cfr18_07.html
(c) Industrial, scientific, and medical (ISM) equipment. Equipment or appliances designed to generate and use locally RF energy for industrial, scientific, medical, domestic or similar purposes, excluding applications in the field of telecommunication. Typical ISM applications are the production of physical, biological, or chemical effects such as heating, ionization of gases, mechanical vibrations, hair removal and acceleration of charged particles.

From this, I understand that a remote control is not an ISM device although it is included in a medical device. Right ?

On the other hand, according to wikipedia ISM_band
the ISM frequencies are commonly used for communication. (bluetooth, RFID..)

I think there is a confusion, right ?
If this is true a remote control in a medical device can use the ISM frequencies but is not an ISM device. So it is regulated by FCC part 15 and not part 18.

If anyone could confirm ? Thanks a lot.

Francis

Hi Francis

As regards ISM radio bands, I would suggest that you contact the International Telecommunications Union (ITU), Radiocommunication sector. They may also help to determine whether your equipment may be considered ICM.

To the extent that you may have a question as to whether your product should be considered as a medical device you may also contact the competent authorities of the Member States where the product is (intended to be placed) on the market.

For the applicable standards, please refer your question to the relevant standardization body.

Regards
S. Subramaniam
 
Last edited:
6

6F_21

#7
Dear members,

Thanks a lot for the inputs.

Nikolaos, I will have a look to those directives.

Bio_subbu, before writing in this forum, i tried to contact standardization bodies and competent autorities. I can tell you that it is definitely very difficult to get clear information. Maybe I was not lucky or didnot contact the godd people. I think that medical product including radio remote control is currently not very common and people are just not aware ?

best regards,

Francis
 
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