IEC 60601-1-2 EMC Testing Optional in US?

S

samuelson

#1
Hello,

I am currently working on getting a Class I medical device to market in the US and realize I must test to the UL - 60601-1 standard, but my question is whether or not the device is needed to test to UL 60601-1-2 for EMC testing?

The device is classified as a Therapeutic Massager under product code ISA
 
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Pads38

Trusted Information Resource
#3
Strictly speaking you do not have to test to 60601-1-2.

However,
that standard is the recognised standard (by FDA) for medical device EMC so it could be good engineering to go ahead and test anyway.

You have to have some confidence that your device will not unduly interfere with other equipment (blank out the TV every time it's switched on) or be affected unduly by other devices / ESD / surges on the power line etc (reliability issues).

There may be ways of simplifying the tests - for instance, if you can show it is a "simple" device with nothing operating above 9kHz, then you can drastically reduce the Emissions tests (using the base CISPR 14-1 standard instead of CISPR 11-1). Similarly, if you are battery powered then many of the Immunity test become Not Applicable.

As your device is 510(k) exempt the involvement of the FDA could be limited to just Establishment Registration. But it may be useful to understand FDA thinking both on EMC and their rather old guidance upon submitting a 510(k) for products like yours.

http://www.fda.gov/Radiation-Emitti...ElectromagneticCompatibilityEMC/ucm116550.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080337.htm
 

cdewitt

Involved In Discussions
#4
If your device has anything that switches at 9KHz or above it needs to be certified that its emissions are below FCC limits to be sold in the US whether they need to meet 60601-1-2 or not. For emissions they amount to the same thing, just the immunity is missing but if you plan to sell in the EU you'll need to meet emissions and immunity.
 

tomshoup

Starting to get Involved
#5
Strictly speaking, if you claim compliance to 60601 that includes all the applicable collateral standards (see clause 1.3 in 60601-1), so you should have objective evidence that you also meet the requirements of the 60601-1-2 collateral EMC standard.

As others have said, if you have a digital device operating above 9kHz, then you have to also comply with FCC regulations in the US. However, digital devices used as medical equipment are exempted from most FCC regulations [47 CFR 15.103 (c) & (d)] but you have to comply with the "etiquette" provision in 47 CFR 15.5 which states that your device can't cause harmful interference with other devices and that your device must accept interference from other devices. The best way to know that your device complies with this etiquette provision is to test to 60601-1-2.
 

thisby_

Involved In Discussions
#6
Hello Tom,

I would like to ask you if, having tested your device for the IEC 60601-1-2 is this enough to say it also complies with FCC?
Here is my problem, we have tested our medical device to comply with IEC60601-1-2 but while I was reading the Guidance Document from the FDA for Radio Frequeny Wireless From August 2013 I got confused and I am not sure if we are suppose to do any other tests or the IEC60601-1-2 is enough to demostrate also compliance with FCC part 15.

Thank you!
Emilia
 

tomshoup

Starting to get Involved
#7
No, testing to 60601-1-2 EMC is not sufficient to claim compliance with FCC regulations. The best way to claim compliance to the FCC regulations is to have your test lab prepare a report based on doing the tests. If you don't have a radio in your device that intentionally transmits (e.g. no WiFi, no Bluetooth), you could probably avoid the cost of another test and use the 60601-1-2 data to compile your own report that demonstrates that your device meets the requirements of what the FCC calls an unintentional radiator, i.e. it emits EM signals because of high-speed digital signals but is otherwise not intended to radiate EM signals.
 

thisby_

Involved In Discussions
#8
Hello again Tom,

I received the report from the test lab and we did both IEC60601-1-2 tests and also CISPR 11 tests. Is this enough to show compliance with the FCC?
Note that our device is an host device for an already FCC certified WiFi module.
I am not sure what the path to follow to an authorization procedure to what concerns the FCC (not sure if Verification is enough or a DoC is needed). Do you have any idea?

What would be the labeling requirements for the Verification case?

I would really appreciate if you could give me some inlights!

Thank you,
Emilia
 

tomshoup

Starting to get Involved
#9
Since your device contains a radio, an intentional radiator in FCC language, your best course would be to go back to your test lab and ask them to prepare a report showing compliance to the FCC regulations. I think it is likely that your test lab only has some of the data they need to show FCC compliance and are likely missing immunity data (CISPR 11 is emission only). But your test lab wants your business and should be willing to give you a quote for preparing a report to show compliance to the applicable FCC regulations. If you knew you had all the data, you could create a matrix that showed the line items in the reports you have traced to the FCC regulations, but you'd have to be proficient in knowing which FCC regulations apply and that the data were acquired in the appropriate way.
 

akp060

Involved In Discussions
#10
Since your device contains a radio, an intentional radiator in FCC language, your best course would be to go back to your test lab and ask them to prepare a report showing compliance to the FCC regulations.
I have a similar issue to this. I have read this multiple times and correlated it with my own search.

1. As per the measurement standards in 47 CFR 15.31, an intentional radiator would have to test to ANSI C63.10-2013.
Electronic Code of Federal Regulations (eCFR)

2. FDA Guidance mentions this standard but is not a recognized consensus standard. In fact, if you search for C63.10 it shows C63.15 (which complements C63.10 as per the former's scope)

3. I have seen that recently FDA cleared devices have mentioned the FCC compliance statement of preapproved modules (tested by the telecommunications bureau) and not test their finished devices to ANSI standards.


My questions with respect to the discussions on this thread are:
1. If tested to IEC 60601-1-2 will ANSI C63.10 or ANSI C63.15 compliance be required given that FCC checks compliance as per 47 CFR 15.31? If yes, what tests are not covered in the former standard?

2. If you have a preapproved module whether there is anything specific in the module's certification that should be mentioned in order to meet FCC compliance without testing for ANSI C63.10
 
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