Test Lab Recommends ANSI C63.27 Wireless Coexistence Testing

We make Medical Equipment using some devices that have Bluetooth technology to talk to each other. We seek 60601-1 approval with national differences for US and EU markets. Suddenly, our lab wants to do Ansi C63.27 testing because "it is on the list of FDA consensus standards".

I can find nothing in the AAMI or UL 60601-1 that requires this testing for US markets. I do not think testing is required merely because ANSI C63.27 is on the FDA consensus list, but I could be wrong.

Additional info:
For our case, considering the loss of Bluetooth communication as a source of harm, the harm is having to restart the equipment to re-execute the procedure. This is the same harm as if the battery in the laptop system goes dead. The procedure is to provide a diagnosis, not maintain life. Thus it is an acceptable risk.

When you say "we seek 60601-1 approval with national differences for US and EU markets", I assume this means asking for a test report or CB certificate confirming compliance with 601-1 + US and EU national differences ("approval" has a special meaning, test labs generally cannot do this).

Whether it is a report or certificate, either way the lab has to stick to standards, not regulations. There is nothing in 601 that links to FDA consensus standards (it could not work that way). Moreover, the FDA's list of consensus standards is not part of the law, it is intended to smooth the path for 510(k) submissions and the listings can often be a bit messy. Anyway, you are right, they cannot insist this.

A test lab could recommend or offer to do the testing as a separate item on the basis that the FDA is likely to ask for a report for this. It could also be good value to do this, a reasonable service. But unless there is a clause in 601-1 that links directly to the ANSI (or any other) standard, the test lab cannot insist it is included as part of the package. If they do insist, it's time to start talking to their accreditation agency.

We've gotten some unexpected requests lately (from FDA), they wanted to see RFID immunity.

As @Peter Selvey points out, it may not be driven from a standard but, based on their experience, they may be saying what they believe the FDA will ask for. A lot may do with the predicate. You might ask them for more rationale. If the FDA expects it, it may be a tough battle to not do it.

I know in the past, we have done wireless coexistence testing on devices with bluetooth. I don't recall what drove it, though, but I do believe it's part of our normal testing when there's a device with bluetooth.

yodon said:

We've gotten some unexpected requests lately (from FDA), they wanted to see RFID immunity.

As @Peter Selvey points out, it may not be driven from a standard but, based on their experience, they may be saying what they believe the FDA will ask for. A lot may do with the predicate. You might ask them for more rationale. If the FDA expects it, it may be a tough battle to not do it.

I know in the past, we have done wireless coexistence testing on devices with bluetooth. I don't recall what drove it, though, but I do believe it's part of our normal testing when there's a device with bluetooth.

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Please clarify what you mean by RFID immunity. Is the RF exposure testing, or co-existence testing?

Here is some additional info on ANSI 63.27

Seems to be for US markets for which AAMI 60601-1 is applied

Lab states that "it is called out by AAMI 60601-1" specification. I have to be honest and say I did not check for any new revisions for the AAMI specification.

If your product has no essential performance defined, then the test does not apply.

If your product has an essential performance defined, the dependence between the essential performance and interference on the wireless link has to be analyzed. The output is one of 3 tiers of testing.

Sorry for being so vague but this is all I have now.

MThomas said:

Please clarify what you mean by RFID immunity. Is the RF exposure testing, or co-existence testing?

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I believe it was exposure testing.

yodon said:

I believe it was exposure testing.

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Yes our lab has also said that FDA has taken a keen interest in exposure testing. Prior to this time, we were only aware of FCC requirements for tissue absorption. There is a table published by OET of the FCC which exempted our devices, but this does not matter any more.

From my experience as an engineer in a test lab, FDA has been requiring evaluation to AIM 7351731 and ANSI C63.27 for nearly every device it applies to. ANSI C63.27 is for wireless coexistence - so only required if your device has a radio. Testing isn't necessarily required, but you absolutely need to address it in your risk assessment.

AIM 731731 is a test for immunity to RFID signals, like the 13.56 MHz RFID or 900 MHz RFID. From the test lab side we're seeing FDA asking for it for basically every product. RFID is in all medical facilities, and common in commercial spaces as well. The amendment A1 of 60601-1-2 was supposed to address this, but there are test results showing a device showed susceptibility to the AIM magnetic field test, but not the 4.1 magnetic field test.

I work in a test lab, and we recommend to our customers to do AIM for every med device.

emceng said:

From my experience as an engineer in a test lab, FDA has been requiring evaluation to AIM 7351731 and ANSI C63.27 for nearly every device it applies to. ANSI C63.27 is for wireless coexistence - so only required if your device has a radio. Testing isn't necessarily required, but you absolutely need to address it in your risk assessment.
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This is a good point. To be clear, our lab has stated that testing to ANSI C63.27 is not necessary if
1- The device has no essential performance as shown in the risk management report, or
2- Loss of radio functionality does not cause loss of essential performance.

I would probably add loss of radio functionality cannot lead to loss of BASIC SAFETY to be formal, but I think that any design and FMEA should address that for reasons other than determining testing to C63.27

The big question remains as to whether this testing is required by AAMI 60601-1, required by some other document, or whether the FDA has been taking field problem reports and asking certain manufacturers to execute this testing because of field problems, or whether it is good " insurance."

I believe the requirement for this standard might be coming from this FDA Guidance around "Radio Frequency Wireless Tech in Med devices".

If you look at Section 3e. - EMC of the wireless technology, FDA's opinion is that 60601-1-2 contains an exemption for immunity testing for in-band frequencies and therefore they don't deem the 60601-1-2 immunity testing to be adequate. From what I can gather the ANSI standard covers wireless coexistence for the use environment which would include the in-band frequencies as well and that is what FDA might be looking for. I guess you could discuss including the in-band frequencies as part of your 60601-1-2 testing and therefore avoid the ANSI standard completely.