Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO

indubioush

Quite Involved in Discussions
#11
Then what's the difference in between VALIDATION and VERIFICATION?

So....., here's my simple thoughts,

Is that clinical accuracy should be validated, to get value in a correct way?
There might not be acceptance criteria defined by ISO standards, we only need to meet customer's requirement.

And that laboratory accuracy must be verified, to get the correct value?
There is indeed acceptance criteria defined by ISO standards, we need to follow that.
I think you are getting on the right track. Verification answers the question, "Did we make the device right?" Validation answers the question, "Did we make the right device?" The validation will test whether the device performs as intended when used in the appropriate setting by the appropriate users.
I suggest you read the US FDA's guidance document on design control. I really think this will help you gain a better understanding.
https://www.fda.gov/media/116573/download
 
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Cybel

Starting to get Involved
#12
When plan the clinical validation study of IR forehead thermometer, all procedures are based on ISO 80601-2-56 or ASTM-E1965-98.

These standards recommend explicit methods for the determination of laboratory accuracy, clinical accuracy and clinical repeatability.
However, only laboratory accuracy is assigned an maximum error criteria ( ±0,3 °C ) within the RATED OUTPUT RANGE.
For clinical accuracy and repeatability, no maximum error criteria is recommended.
So I don't know if the clinical result of IR forehead thermometer is acceptable or not.


Is there any explanations?
Hi.
From my understanding, in the clinical accuracy validation there is not a PASS/NON PASS threshold.
ISO 80601-2-56:2017 states that "The results of CLINICAL ACCURACY VALIDATION shall be disclosed in the ACCOMPANYING DOCUMENT. This disclosure shall include: the CLINICAL BIAS, Δcb, with its LIMITS OF AGREEMENT, LA, the CLINICAL REPEATABILITY, σr, the REFERENCE BODY SITE and MEASURING SITE for each OPERATING MODE."

It appears this means that it's up the user decision if the device is accurate enough or not.
This support the track of "customer requirements" as suggested by indubioush.
 
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