IEC 60601-1-2 for very simple Medical Device Accessory

Z

zantoz24

#1
Hello, we would like to comply with the standard IEC 60601-1-2:2007, General Requirements for Safety ? Collateral Standard; Electromagnetic Compatibility ? Requirements and tests, for one of our products, these are temperature probes, these probes consist basically in a thermistor, the cable and the connector, and are intended to be used in conjunction with different monitors or infant incubators. This means that the probes can be used with several monitors even of different brands.

We're having a hard time trying to figure out whether we need to perform tests, and which kind of tests.
Obviously performing a test just to the probe makes no sense, since by itself is not even a circuit.
First we thought that a statement in the label would be enough, but now we are not so sure.
To test the probes with every compatible monitor is hard to implement.
So at this point we don't know what we have to do.
Any advice will be really appreciated.
Eduardo.
 
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Peter Selvey

Staff member
Super Moderator
#2
The strictly correct way is for the patient monitor manufacturer to specify the exact probes and accessories to use with their equipment, and then they take the responsibility of selecting and testing the worst case for compliance with IEC 60601-1-2.

Another option could be for the patient monitor manufacturer to create a dummy probe which they consider worse case than real probes (e.g. long, unshielded, untwisted cable), and then test to show their monitor is still OK in EMC testing. That way they could claim broad compatibility with all probes in the market.

Either way, there is no point for the manufacturer of the probe to have the probe formally tested against IEC 60601-1-2. It makes no sense, not least because as you say there is no control over which monitor the probe could be used with in the real market.

Under most regulations, you do have an obligation to research and find out what is state of the art for protection against EMC in long cables, for example, use and types of shielding, twisted cable, insulation types etc and then do your best to minimize the noise.

That said, a temperature is a very low frequency measurement, so the monitor manufacturer can usually filter out any noise (both incoming and outgoing).
 
Z

zantoz24

#3
Peter: Thank you for your detailed answer.
What you said was our first interpretation, the responsibility is for the manufacturers of the patient monitors, but then we found this in the standard:

5.2.2.7 **Requirements applicable to cables, transducers and other*ACCESSORIES*that*could affect compliance with the requirements of 6.1 and 6.2
*
For cables, transducers and other
ACCESSORIES*that could affect compliance with the*requirements of 6.1*[Emissions]*and 6.2*[Immunity], the*ACCOMPANYING DOCUMENTS*shall include the following*information:
*
a) a list of all*ME EQUIPMENT*and*ME SYSTEMS*with which the*ACCESSORY, transducer or cable*may be used and that are claimed by the*MANUFACTURER*of the*ACCESSORY, transducer or
cable to be in compliance with the requirements of 6.1 and 6.2 when used with the*ACCESSORY, transducer or cable. References shall be specific (e.g. by*MANUFACTURER*and
MODEL OR TYPE REFERENCE
); and
*
b) a warning that the use of the*ACCESSORY, transducer or cable with*ME EQUIPMENT*and*ME SYSTEMS*other than those specified may result in increased*EMISSIONS*or decreased*IMMUNITY*of the*ME EQUIPMENT*or*ME SYSTEM.

Somehow the above article implies that we should have to perform some tests, right?
 

Peter Selvey

Staff member
Super Moderator
#4
Yes, actually I originally planned to highlight the wrong approach by IEC, but thought I would try to avoid being negative. Unfortunately it seems they have written clearly into the standard, so there is no choice ...

The approach is legally wrong, and so clearly incorrect that I believe it's OK to ignore the standard for this point.

Under medical device regulation, it is perfectly OK for a user (doctor/hospital etc) to put two medical devices A and B together to form a system, where the manufacturers for A nor B have never conducted testing of that system, have no agreement, contract or even casual contact. It happens all the time.

The regulators are aware that there is a risk of incompatibility. It's true this is a serious concern. As such, the IEC has taken the approach that you must clearly define the exact system, test that particular system, and label for use only with the tested systems.

The problem ... it does not work unless there is a contractual agreement between manufacturers A and B. Without this agreement the test is meaningless.

Consider: Temp probe A is tested with patient monitor B.

Everything passes. Great.

Then, 6 months later, patient monitor B changes a filter capacitor, re-routes the Temp PCB a bit, and fixes some software bugs including the software filter.

According to IEC approach, the new system of A and B needs to be tested again, as the changes could affect EMC.

But how does manufacturer A know that B made the design changes? They cannot, unless they have contractual agreement.

Similarly Probe manufacturer A could change the shielding to a cheaper type. Again how does manufacturer B know manufacturer A made the change?

Regulators have recognized that although there is a risk, it would be impossible to have a network of agreements and contracts between manufacturers all over the world, with each possible system being re-tested every time a design change is made.

Rather, it is better to make each component of a system robust (assume the worst case), and to keep to clearly defined interface specifications which each manufacturer can work with.

JIS, ISO, EN, ANSI/AAMI standards have tended to follow regulations, with lots of standards for components (such as sensors), written in a way to ensure wide compatibility. ANSI/AAMI BP 22 (JIS 3233) for IBP sensors is an example; EN 12470-4 for temperature allows the probe and indicating unit to be tested separately.

IEC however have their head stuck in the sand, and keep insisting on testing the system. It's not only EMC but many IEC standards show this approach. It does not work, it's not legally sound, and sooner or later someone will have the guts to challenge it in court.
 
Z

zantoz24

#5
Thanks again Peter.
I agree with what you say.
I guess we will try to test our probes with some of the patient monitors and incubators, and try to make a kind of inductive argument.
We are doing this for FDA purposes, and we think that they will ask us for some EMC requirements, and since 60601-1-2 is a recognized standard it should be the one to be used.
 
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