29
Table 2:Repeatability Requirement
Table 1: Accuracy Requirement
13. Performance
1.1mmol/L~5.55mmol/L
(20mg/dL~100mg/dL)
5.55mmol/L~33.3mmol/L
(100mg/dL~600mg/dL)
Within ±0.83mmol/L(±15mg/dL)
Within ±15%
Accept Bias
Test Range
Accuracy and repeatability criteria for this product is
refer to national standard GB/T19634-2005 In vitro diagnostic
test systems -General technical requirements for blood-glu-
cose monitoring systems for self-testing and International
standard EN ISO 15197:2015 In vitro diagnostic test systems
—Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus.
Accuracy requirement: ≥95% of test result bias shall
meet table 1 requirement.
Repeatability requirement: test result shall meet table 2
requirement.
1.1mmol/L~5.55mmol/L
(20mg/dL~100mg/dL)
SD<0.34mmol/L(6 mg/dL)
Precision
Test Range
CV<6%
5.55mmol/L~33.3mmol/L
(100mg/dL~600mg/dL)
Содержание TRUE METRIX AIR
Страница 1: ...1 1 1 2 1 3 1 4 2 1 2 2 4 1 4 2 4 3 4 4 6 1 6 2 1 3 3 3 3 3 3 3 3 6 10 10 10 12 14 15 15 15 16...
Страница 2: ...2 17 1 17 2 17 3 17 4 17 18 18 19 19 19 24 25 26 27 27 28 29 30 31...
Страница 4: ...4 2 2 1 TRUE METRIX TRUE METRIX AIR TRUE METRIX TRUE METRIX AIR 1 2 3 1 2 3 4 5 6 1 2 3 4 5 6...
Страница 5: ...5 PC 2 2 2...
Страница 6: ...6 7 8 9 10 11 12 13 1 2 3 TRUE METRIX AIR 4 5 6 1 2 4 13 12 11 10 9 8 7 5 3 6...
Страница 7: ...7...
Страница 8: ...8 7 14 30 60 TRUE METRIX AIR 90 TRUE METRIX AIR TRUE METRIX AIR TRUE METRIX AIR...
Страница 9: ...9 33 3mmol L 1 1mmol L...
Страница 10: ...10 4 1 1 3V CR2032 1 2 3 4 4 4 2 TRUE METRIX AIR...
Страница 11: ...11 1 1 2 3 4 2 TRUE METRIX AIR TRUE METRIX TRUE METRIX AIR 2...
Страница 12: ...12 13 3 mmol L 4 10 1 2 3 4 1 3 3 2 1 4 3...
Страница 13: ...13 4 2 10 3 4 1 5 6 7 8 9 10 11 12...
Страница 15: ...15 6 1 1 2 13 3 mmol L 1 2 E 2 10 2 2 3 2 2 4 2 5 10...
Страница 16: ...16 6 2 6 2 1 3 2 6 2 2 TRUE METRIX 1 3 4 2 10 3...
Страница 17: ...17 3 4 5 6 7 8 9 10 TRUE METRIX AIR...
Страница 18: ...18 5 1 2 75 3 75 4 5 75...
Страница 19: ...19 1 2 3 4 5 6 7 8...
Страница 20: ...20 1 2 2 2...
Страница 21: ...21 3 5 C 4 0 C 1 0...
Страница 22: ...22...
Страница 23: ...23 33 3mmol L Hi 1 1mmol L Lo...
Страница 26: ...26 1 TRUE METRIX AIR 8 1 9600bps 16 4 2 Bluetooth Low Energy 2 3 1 1 3V CR2032 4 1...
Страница 27: ...27 EMC GB T 18268 1 2010 GB T18268 26 2010 EMC 1 2 3 4 CMIIT ID SN...
Страница 28: ...28 17 1 GB4824 GB 4824 GB 17625 1 GB 17625 2 1 B...
Страница 32: ...32 2 2017 2 4 4 7 0mmol L 79 mg dL 126 mg dL 3 9 6 1 mmol L 70 mg dL 110 mg dL 2014 GDM 5 3mmol L 95mg dL...
Страница 33: ...33 GB T 26572 GB T 26572 10 Pb Hg Cd Cr VI PBB PBDE...
Страница 34: ...34 GB T 26572 GB T 26572 10 Pb Hg Cd Cr VI PBB PBDE...
Страница 35: ...35 400 887 0036 1...
Страница 36: ...36...
Страница 37: ...37 2...
Страница 38: ...38...