Is FCC required for Medical Equipment without Radio Frequency Energy?

[Roland chung]

Hello all,

FCC PART 18 and PART 15 seems to be appropriate to radio frequency device only. The product concerned is medical suction equipment which consists of DC pump and approved stand alone power supply. The agent told me that FCC should be considered if the product intended to be sold in the US market.

I am totally confused. Could anyone help to clarify it? Is there a FCC training stuff? As I am quite new to the FCC.

Thanks and regards,
Roland

 

[MIREGMGR]

As far as I know, if you've established from physical principles, engineering knowledge and testing if required that your device does not emit RF energy, you would memo-to-file that decision process and subsequently regard FCC regulation as not applicable to your device.

However: how does your power supply work? If it's switching type, usually it needs to be engineered to not have unacceptable RF emissions and to be classifiable so that the applicable regulations are those for your intended use rather than a stricter set. It might need additionally to be evaluated and tested to verify compliance. If your "approved" status already incorporates all of that, you're good to go. Otherwise, maybe not.

 

[Roland chung]

MIREGMGR, thank you for your input.

From your point of view, it seems that medical equipment employed switching power supply needs to meet FCC regulations. Is there an official statement?

So far as I know, none FDA guidance documents mention FCC requirement. Generally, IEC60601-1-2 (EMC) is recommended by FDA.

Actually, I am also wondering if medical equipment has been FDA clearanced is sufficient from the regulation point. For OSHA and FCC, how they function?

 

[MIREGMGR]

FCC and FDA have no interaction or cross requirements. FDA clearance is irrelevant as far as FCC is concerned. Same with OSHA.

IEC 60601-1 is a standard providing for patient and user safety, etc. It has nothing to do with management of the RF spectrum, which is what FCC does.

As to written rules, start at the FCC website.

RF emitting equipment of any kind has to meet FCC rules in USA. Whether it is medical equipment is irrelevant, other than consideration of the intended use of the equipment and therefore what rules apply to it, i.e. consumer equipment has one set of rules, business equipment another, industrial equipment a third. Equipment that isn't intended to emit RF as part of its function is governed differently from, say, an RF welder or radio transmitter.

Power supplies are not intended to emit RF, therefore the rules generally don't allow them to do so in excess of certain limits.

 

[Roland chung]

Thank you again.

Another question is if rule PART 15 also includes medical device. How do I know PART 15 or PART 18 should be used?

 

[MIREGMGR]

Outside of my range of expertise.

 

[jdoran]

@Roland chung
I also came across the following:
"According to FCC Part 15.103, medical equipment is exempt from the FCC's technical standards. FCC Part 15.103e lists the following exemption: "Specialized medical devices (generally used at the direction of or under the supervision of a licensed health care practioner) whether used in a patient's home or a health care facility." Link

However, in practical terms I'm not sure what this means, i.e. whether FCC ID still needs to be applied, if any FCC related information needs to be added to the IFU, or if all FCC related testing is exempt. If you have found any further information since your original post, I would be very interested to know, thanks!