ISO 80601-2-56 Laboratory accuracy

[crriis]

Hello,

Our company develops a medical infrared thermometer. As per standart 80601-2-56:2017, we will perform the "clinical accuracy validation" (§201.102) of our MD by comparing our temperatures values to a RCT (Reference Clinical Thermomter). This clause compells us to "Before and after the tests, confirm the LABORATORY ACCURACY of the RCT with a REFERENCE TEMPERATURE SOURCE" (201.102.1 a)). The LABORATORY ACCURACY (§201.101.2) requires to use very accurate REFERENCE TEMPERATURE SOURCE that "has an expanded measurement uncertainty (covering factor k = 2) of not greater than 0,07 °C."

Here is the problem, where can we find a company that has/sells a compliant REFERENCE TEMPERATURE SOURCE to confirm the LABORATORY ACCURACY of our RCT ? We asked lot of classical metrology companies and they all answered that a blackbody with this expanded measurement uncertainty doesn't exist...

Regards.

 

[crriis]

Hello,
up on this topic.
Thanks

 

[Ed Panek]

Is this a 510(k). WHat was the predicate device?

 

[crriis]

Hello Ed,
Thanks for answering.
It's for CE marking of our product. The predicate device (=RCT if I understand well what you're asking) is a "Visiomed ThermoFlash LX 26", that is already CE marked...

 

[Ed Panek]

We tested our thermometer to ASTM E1112 and argued that this standard is more strict than 80601 and that was accepted under MDD.

 

[crriis]

Thanks for your answer Ed,

Now that there is MDR, maybe the NBs wil change their minds... What is the company that perform your ASTM test ? I've googled it and there were only links to the ASTM standart. You can PM me if it's not appropriate to write it in the discution thread.

 

[OcciDoc]

Hello Ed and Crriss,

We are facing the exact same issue here ... such tolerance accuracy does not exist !! Would you be able to share the lab name that was able to perform such test ?

We would be so grateful,

Thank you in advance for your precious help,

 

[Benjamin Weber]

You should look for a competent calibration laboratory, ideally accredited to ISO 17025. Each country has a national accreditation body (e.g. in Germany this would be the "DAkkS"), where you can get more information about accredited labs.

I just had a very quick look and found a lab that states an expanded measurement uncertainty down to 0,015 K for the calibration. (Trescal, Braunschweig, Germany, https://www.dakks.de/files/data/as/pdf/D-K-15015-01-10.pdf)

If you have no idea about your national accreditation body you can look at the website of European Accreditation: Search Facility - European Accreditation

I hope this helps!