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?
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?