44
Osmo1
™
Single-Sample Micro-Osmometer Service Guide
Appendix B
Performance characteristics
Definitions
Accuracy
Closeness of agreement between a test result and the accepted reference value (ISO 5725-1)
Repeatability
Precision under conditions where independent test results are obtained with the same method on identical test items
in the same laboratory by the same operator using the same equipment within short intervals of time (ISO 5725-1:1994)
Source: Harmonized Terminology Database at http://clsi.org
Characteristics
Reportable Range
0–2000 mOsm/kg H
2
O
Resolution
1 mOsm/kg H
2
O
Accuracy
1
(AI standards and reference solutions)
≤
2 mOsm/kg H
2
O from nominal value between 0 and 400 mOsm/kg H
2
O (1 SD)
≤
0.5% from nominal value between 400 and less than 1500 mOsm/kg H
2
O (1 SD)
≤
1% from nominal value from 1500 to 2000 mOsm/kg H
2
O (1 SD)
Within-Run Repeatability
1
(AI standards and reference solutions)
Standard deviation
≤
2 mOsm/kg H
2
O between 0 and 400 mOsm/kg H
2
O (1 SD)
Coefficient of variation
≤
0.5% between 400 and less than 1500 mOsm/kg H
2
O (1 SD)
Coefficient of variation
≤
1% from 1500 to 2000 mOsm/kg H
2
O (1 SD)
Temperature Effects
Less than 1 mOsm/kg H
2
O for every 5 °C (9 °F) ambient temperature change
Operating Conditions: Temperature 18 °C to 35 °C (64 °F to 95 °F); 30 to 80 % relative humidity (non-condensing).
1 Performance at Reference Conditions: 20 °C to 25 °C (68 °F to 77 °F); 40 to 60% relative humidity.