Table 3.

User Performance Evaluation Following ISO 15197 Standard.

	ISO 15197:2003	ISO 15197:2013
Acceptance criteria		95% of measurements obtained within ±15 mg/dl of the reference measurement results at glucose concentrations <100 mg/dl and within ±15% at glucose concentrations ≥100 mg/dl
Number of test strip lots	3	1
Performance of measurements with the SMBG system	At least 50 subjects	At least 100 diabetic subjects
Sample type	Capillary whole blood	Capillary whole blood
Determination of accuracy	Results measured by the subjects shall be compared to	Results measured by the subjects shall be compared to
	• results obtained with the reference measurement procedure	results obtained with the reference measurement procedure
	• results obtained by medical/laboratory personnel from the same sample
Reference measurement procedure	Manufacturer’s measurement procedure	Any method with verified metrological traceabilitya
Collection of samples for reference measurements	Within 5 minutes after the subject’s measurement with the SMBG system by medical/laboratory personnel	Within 5 minutes after the subject’s measurement with the SMBG system by medical/laboratory personnel
Training material/practice tests	Instructions for use, etc routinely provided with the system	Instructions for use, etc routinely provided with the system/subjects may be allowed a limited number of practice tests
Incorrectly performed measurements		The measurement can be repeated if the subject reports a mistake (a maximum of 3 data exclusions due to incorrectly performed measurements shall be allowed)
Human factors	User technique observation by the medical/laboratory personnel	User technique observation by the medical/laboratory personnel
Evaluation of the instruction for use	Ease of understandingb	Ease of understandingc

^aNot clearly defined but indicated.

^bThe evaluation method is not described in detail.

^cThe evaluation method is described in detail.