This standard specifies the terms and definitions, requirements, test methods, labeling and instructions for use, packaging, transportation and storage of self-testing blood glucose monitoring systems. This standard applies to self-testing blood glucose monitoring systems (usually including portable blood glucose meters, disposable test strips and quality control materials) for in vitro monitoring of glucose concentration in human capillary whole blood and/or venous whole blood. GB/T 19634-2005 General technical requirements for self-testing blood glucose monitoring systems for in vitro diagnostic test systems GB/T19634-2005 Standard download decompression password: www.bzxz.net

ICS.11.100
National Standard of the People's Republic of China
GB/T19634--2005
In vitro diagnostic test systems
General technical requirements for blood-glucose monitoring systems for selr-testing
(1S0 15197:2003,NFQ
2005-01-24 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2005-05-01 Implementation
GB/T196.34—2005
Normative references
Terms and definitions
Test methods
Labels and instructions for use
$References
Table 1 Table 2 Accuracy requirements for blood glucose and blood glucose concentration range for blood glucose test Table 1 Requirements for blood glucose samples for system accuracy test Date/19634-2005 General technical specifications for blood glucose monitoring system for self-testing are consistent with GB/T19634-1501519--Conformity with GB/T19634 in vitro diagnostic test system The standards are not equivalent. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems. The drafting units of this standard are: Beijing Medical Device Inspection Institute, Guan Guo Johnson Company. The main drafters of this standard are: Lang Donghui, Xu Yong, and Johu Mahoney. GB/F 19634—2005
Blood pressure monitoring systems are mainly used by non-professionals as external diagnostic medical devices. When used correctly, they can help diabetic patients monitor and take measures to control the concentration of glucose in their blood. The main purpose of this standard is to meet the requirements of blood pressure monitoring systems designed for use by non-professionals to obtain acceptable results when the user has received appropriate training, the instrument has been properly maintained, and it has been operated in accordance with the manufacturer's specifications and quality control procedures. This standard specifies the procedures for verifying the performance of blood glucose monitoring systems. This standard describes the general technical properties of self-testing blood glucose monitoring systems, which mainly refers to the information provided by the manufacturer, including the label and instructions for use of the self-testing blood glucose monitoring system. Since the test system is for non-professionals, the information provided by the manufacturer should be clear and easy to understand so that users can understand and correctly follow the operating procedures to perform self-testing. At the same time, appropriate warnings or prompts should be provided to guide the appropriate measures to be taken when abnormal results occur. This standard provides detailed provisions for the information provided by manufacturers.
In vitro diagnostic test system
General technical conditions for self-testing blood glucose monitoring systems GB/T 19634-2005
This standard specifies the terms and definitions, requirements, test methods, labeling and instructions for use, packaging, transportation and packaging of self-testing blood glucose monitoring systems.
The rate standard is applicable to the self-testing blood glucose monitoring system (usually including portable blood collection, disposable test tube and quality control material) for monitoring the glucose level in human capillary whole blood and intravenous whole blood in vitro. 2 Normative references
The references in the following inscriptions are the terms of this standard through reference to this standard. For all referenced documents with dates, all subsequent amendments (excluding errors) or revisions are not applicable to this standard. However, the parties who have reached an agreement on the date of this standard are encouraged to study whether the latest versions of these documents can be used. For any out-of-date referenced documents, the latest applicable standards are GB4793.1-1995 Safety requirements for electrical instruments for measurement and control laboratories Part 1: Applicable requirements GB/T 1010-1995 Medical electrical exposure Part 1: Safety requirements (IFCG0-158) GB/T 14710.-1993 Environmental requirements and test methods for electrical instruments YY466-2003 Medical devices Symbols for marking, labeling and providing information for medical devices IS15223-2001 IDT) 3 Terms and definitions |The following terms and definitions are used in this standard
temperature monitoring system
degree of agreement between a measured value and a variable reference value [IS33531-11993.3.11]
Note: In IS0334-1 and IS0335-1133, the concept of "reference value" rather than "acceptable reference value" is used here: 2. When the term "standard" is used for batch processing, it includes both the random detection part and the common system part. 3.2
Blood Glucose Monitoring System Bluud-Glucose Monitoring System SYSLCM comprises a test system that uses an instrument and test strips compatible with it and quality control materials to monitor blood concentration. Note 1 that the blood test system can be used to measure the concentration of whole blood or blood samples to show the results. 3.3 System accuracy refers to the degree of agreement between a set of representative test results obtained by a measurement system and their respective reference values. 1. System accuracy can be expressed as the range between 95% and 95% of the values ​​obtained by the system. The core range also includes all measurement differences. 3. 4
Precision
The numerical value of the results of five independent tests under specified conditions. CB/T196342005
[IS3524-1,1993, definition 3.14
Note] The degree of precision is expressed in terms of statistically significant numbers, namely the standard deviation (SD) and the coefficient of variation (C), which are negatively correlated with the precision. For the specified case, the precision will be the same. Note 2: The precision of a measurement range can be determined based on the specified precision conditions. The precision under the specified conditions will be the precision and repeatability.
Repeatability
The consistency between the results of a number of consecutive tests on the same test under the same measurement conditions. IJJF1001-1U08 definition 5.6]
repeatabllty conditionlong
repeatabllty condition
condition that the same independent test results are obtained from the same test partner in a short time in the same laboratory, the same operation, the same instrument, and the same test method, and the same independent test results are obtained from the same test partner in a short time,
_[ISO 3534-1;1993, definition 3,16
Note: the basic water is determined by the conditions, and the conditions that can be used to obtain the minimum change and the result, 3.7
blood glucose monitor
a device for blood glucose monitoring system, which can convert the result of chemical reaction into the concentration of bacteria in the sample. 3.8
label||printed on the device, with the information indicated by the doctor. 3.9
Instructions for use: information manual for blood test system provided by the manufacturer. Contents include safe and correct use of reagents or safe and correct operation of the instrument, maintenance and basic fault solving methods: Note: Instructions for use include the user's instructions for use and the instructions for use of quality control materials not attached to any part of the device. 3.10
Packaging insert
Instructions for use together with the label and quality control materials not attached to any part of the device. 3.11
Non-professional layperson
Individual who has not received formal training in the corresponding field or discipline. Note: in the standard, trained users refer to those who do not have special medical, scientific or technical experience related to the application of life monitoring. 3.12
Batch bntch(lut)
One or more device parts are complete devices, which contain a single type, rate number, category, size, composition, or version of the device produced under the same circumstances, and have the same characteristics and quality under certain conditions. 3.13
Packed cell volume packed cell yolunie
The volume fraction of fat in the micrometer.
Note: It can be expressed as a whole (> or min). Change the setting to use a single treatment). Note 2: In the case of only the most direct assessment of the amount of the product, the manufacturer's standing easurement procedure is a measurement procedure that has been calibrated with a calibration fluid of a higher type by one or more manufacturers and has been verified for its intended use. 3.15 Control material is a quantity, sample or crystal that the manufacturer uses to verify the performance characteristics of an external diagnostic medical instrument. 3.16 Quality control range is a range of values ​​specified by the manufacturer within which the results obtained from the control material are scientifically acceptable. [ISO/DIS, 2151S7 definition 3.14]
blood-glucose test blood-glucose teststrlsps blood-glucose test ... 1 day
User adjustments to the blood glucose monitoring system are described in the instructions for use, including user operation steps, including code addition, and code addition, to achieve acceptable performance of the system.
Batch-to-batch variability
The ratio of the amount of standard added actually detected to the known amount of standard added after the quantitative standard is added to the sample, expressed as a percentage or decimal.
4 Requirements
4.1 Appearance
) The appearance of the blood glucose meter should be neat, with clear text and markings. 1) The blood glucose test strips should be free of stains, and the front sampling area should be clean and free of rivers. 2) The quality control materials purchased should be uniform and consistent.
4.2 The blood collection and blood volume of the blood glucose meter and the blood glucose test strips should meet the requirements of Table 1. Table 1 Measurement accuracy of blood glucose meter and blood glucose test strips
-c5. 5 mrmul,L
(10 ug/UL)
5. 5 mmol/[.]
(100 mgdi)
4.3 System accuracy of blood glucose meter and blood glucose test strips The system accuracy of blood glucose meter and blood glucose test strips shall meet one of the following requirements:
SE-0. 42 nmmul/L
(7.7 lug/UL)
GH/T19634—2005
a) The blood glucose measurement result shall not differ by 3% and shall meet the requirements of Table 2; b) The recovery rate of blood glucose meter and blood glucose test strips shall be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L14
Manufacturer's standing measurement procedure GB/T19634—2005
A measurement procedure that has been calibrated with a calibration fluid of a higher type by one or more manufacturers and has been verified for its intended use. 3.15
Control material contrnlmaterialis
The quantity, sample or crystal used by the manufacturer to verify the performance characteristics of an external diagnostic medical instrument. 3.16
Quality control range
The range of values ​​specified by the manufacturer within which the results obtained from the control material are scientifically acceptable. [ISO/DIS, 2151S7 definition 3.14]
blood-glucose test blood-glucose teststrlsps blood-glucose test ... 1 day
User adjustments to the blood glucose monitoring system are described in the instructions for use, including user operation steps, including code addition, and code addition, to achieve acceptable performance of the system.
Batch-to-batch variability
The ratio of the amount of standard added actually detected to the known amount of standard added after the quantitative standard is added to the sample, expressed as a percentage or decimal.
4 Requirements
4.1 Appearance
) The appearance of the blood glucose meter should be neat, with clear text and markings. 1) The blood glucose test strips should be free of stains, and the front sampling area should be clean and free of rivers. 2) The quality control materials purchased should be uniform and consistent.
4.2 The blood collection and blood volume of the blood glucose meter and the blood glucose test strips should meet the requirements of Table 1. Table 1 Measurement accuracy of blood glucose meter and blood glucose test strips
-c5. 5 mrmul,L
(10 ug/UL)
5. 5 mmol/[.]
(100 mgdi)
4.3 System accuracy of blood glucose meter and blood glucose test strips The system accuracy of blood glucose meter and blood glucose test strips shall meet one of the following requirements:
SE-0. 42 nmmul/L
(7.7 lug/UL)
GH/T19634—2005
a) The blood glucose measurement result shall not differ by 3% and shall meet the requirements of Table 2; b) The recovery rate of blood glucose meter and blood glucose test strips shall be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L14
Manufacturer's standing measurement procedure GB/T19634—2005
A measurement procedure that has been calibrated with a calibration fluid of a higher type by one or more manufacturers and has been verified for its intended use. 3.15
Control material contrnlmaterialis
The quantity, sample or crystal used by the manufacturer to verify the performance characteristics of an external diagnostic medical instrument. 3.16
Quality control range
The range of values ​​specified by the manufacturer within which the results obtained from the control material are scientifically acceptable. [ISO/DIS, 2151S7 definition 3.14]
blood-glucose test blood-glucose teststrlsps blood-glucose test ... 1 day
User adjustments to the blood glucose monitoring system are described in the instructions for use, including user operation steps, including code addition, and code addition, to achieve acceptable performance of the system.
Batch-to-batch variability
The ratio of the amount of standard added actually detected to the known amount of standard added after the quantitative standard is added to the sample, expressed as a percentage or decimal.
4 Requirements
4.1 Appearance
) The appearance of the blood glucose meter should be neat, with clear text and markings. 1) The blood glucose test strips should be free of stains, and the front sampling area should be clean and free of rivers. 2) The quality control materials purchased should be uniform and consistent.
4.2 The blood collection and blood volume of the blood glucose meter and the blood glucose test strips should meet the requirements of Table 1. Table 1 Measurement accuracy of blood glucose meter and blood glucose test strips
-c5. 5 mrmul,L
(10 ug/UL)
5. 5 mmol/[.]
(100 mgdi)
4.3 System accuracy of blood glucose meter and blood glucose test strips The system accuracy of blood glucose meter and blood glucose test strips shall meet one of the following requirements:
SE-0. 42 nmmul/L
(7.7 lug/UL)
GH/T19634—2005
a) The blood glucose measurement result shall not differ by 3% and shall meet the requirements of Table 2; b) The recovery rate of blood glucose meter and blood glucose test strips shall be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L14]
Blood glucose test blood-glucose ... 1 day
User adjustments to the blood glucose monitoring system are described in the instructions for use, including user operation steps, including code addition, and code addition, to achieve acceptable performance of the system.
Batch-to-batch variability
The ratio of the amount of standard added actually detected to the known amount of standard added after the quantitative standard is added to the sample, expressed as a percentage or decimal.
4 Requirements
4.1 Appearance
) The appearance of the blood glucose meter should be neat, with clear text and markings. 1) The blood glucose test strips should be free of stains, and the front sampling area should be clean and free of rivers. 2) The quality control materials purchased should be uniform and consistent.
4.2 The blood collection and blood volume of the blood glucose meter and the blood glucose test strips should meet the requirements of Table 1. Table 1 Measurement accuracy of blood glucose meter and blood glucose test strips
-c5. 5 mrmul,L
(10 ug/UL)
5. 5 mmol/[.]
(100 mgdi)
4.3 System accuracy of blood glucose meter and blood glucose test strips The system accuracy of blood glucose meter and blood glucose test strips shall meet one of the following requirements:
SE-0. 42 nmmul/L
(7.7 lug/UL)
GH/T19634—2005
a) The blood glucose measurement result shall not differ by 3% and shall meet the requirements of Table 2; b) The recovery rate of blood glucose meter and blood glucose test strips shall be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L14]
Blood glucose test blood-glucose ... 1 day
User adjustments to the blood glucose monitoring system are described in the instructions for use, including user operation steps, including code addition, and code addition, to achieve acceptable performance of the system.
Batch-to-batch variability
The ratio of the amount of standard added actually detected to the known amount of standard added after the quantitative standard is added to the sample, expressed as a percentage or decimal.
4 Requirements
4.1 Appearance
) The appearance of the blood glucose meter should be neat, with clear text and markings. 1) The blood glucose test strips should be free of stains, and the front sampling area should be clean and free of rivers. 2) The quality control materials purchased should be uniform and consistent.
4.2 The blood collection and blood volume of the blood glucose meter and the blood glucose test strips should meet the requirements of Table 1. Table 1 Measurement accuracy of blood glucose meter and blood glucose test strips
-c5. 5 mrmul,L
(10 ug/UL)
5. 5 mmol/[.]
(100 mgdi)
4.3 System accuracy of blood glucose meter and blood glucose test strips The system accuracy of blood glucose meter and blood glucose test strips shall meet one of the following requirements:
SE-0. 42 nmmul/L
(7.7 lug/UL)
GH/T19634—2005
a) The blood glucose measurement result shall not differ by 3% and shall meet the requirements of Table 2; b) The recovery rate of blood glucose meter and blood glucose test strips shall be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L7 lug/UL)
GH/T19634—2005
a) The blood glucose should be within 3% of the difference between the blood glucose test strip and the result, which should meet the requirements of Table 2; b) The recovery rate of the blood glucose meter and the Glucose test strip should be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L7 lug/UL)
GH/T19634—2005
a) The blood glucose should be within 3% of the difference between the blood glucose test strip and the result, which should meet the requirements of Table 2; b) The recovery rate of the blood glucose meter and the Glucose test strip should be within %～1. 2 Accuracy requirements
Test range
≤1.2:1,T
(g/L)
-4,2 mT.It:I,1.
+2y5 rng/l.:
4.4 Batch difference of blood glucose test strips
The batch difference of different batches of blood glucose test strips should not be greater than 1%. 4.5 Quality control quality
9% of the test results of quality control materials should be within the blood glucose test range: 4.6
The average environmental test of blood glucose meter
shall comply with the requirements of the applicable clauses in GB/T14710-1SS8. 4.7 Safety requirements for blood glucose meters
The allowable value shall not exceed ±0.83/
(=15ng/dL)
Not exceed ±20%
The test shall comply with the requirements of R9706.1-993 and/or (4793.1-1995) 5 Test methods
Test materials
Blood glucose collection (it is recommended that at least 2 standard blood glucose meters be used) Blood glucose test strips!
|Analytical equipment in accordance with the manufacturer's recommendations: Blood sample from glomerular or capillary blood;
Blood sample with appropriate anticoagulant added;
Low speed centrifuge:
Reference colorimetric or small test tube: Manufacturer's instructions for calibration and quality control: k) Disposable pipette. 5.2 Appearance
Check with normal vision or normal vision
5.3 Blood Detection and Blood Authenticity Test Strips Collect fresh blood from donors with a blood pressure of 0.3L/~0.5C1L35 head~-=6>, and avoid injecting blood into test tubes containing antibiotics if the manufacturer recommends: freeze the sample at room temperature (23±5) for at least 1 minute, and quickly let the sample temperature reach 2℃. Use the blood concentration range in Table 3 to perform the authenticity test with 5 venous whole blood samples. Each sample should be gently swirled before testing, including thorough mixing, and then tested 20 times on a separate blood glucose monitor according to the manufacturer's instructions for use under reproducible conditions. Two equal portions should be collected from the product immediately before the first test on the blood glucose monitoring system to determine if the result shows a drift effect (usually the difference between the first result and the second result is 0.2mmol/L+mg/dL at a blood glucose concentration of 5.5mmol/(100m/dl) or 4% at a blood glucose concentration of 5\l/TGB/T 19634-20C5
(100/L)), then the test result of the sample is invalid and the sample needs to be tested again. Calculate the standard () and coefficient of variation (
Note: You can use 0.2% normal saline to make an equal portion of the blood before the blood is resistant to arterial blood disorders. The amount of the shadow product is as much as possible. In the case of a person with a new blood disorder, only one will disturb the blood at the planned rate: horse positive amine, obvious chemical. Or · Mingbei end can salt drop to avoid temporary renal group: in order to obtain the necessary area of ​​blood rottenness, you can wait for the blood to be changed at night, so that the commonality of the initial solution brought by the level
Repeatability test with blood glucose concentration range
broadcast pressure olg/
-.7--2.8(0--SC:
r. $--6. 1(51--11c:
e. 3--8. 3+.l: -- 150)
8. 4-- 13. 9(151--250)
14.--22.2(251--46)
5. 4 Blood position and blood glucose test strip system accuracy considerations 5. 4. 1 Test venous blood sample (instead of capillary blood sample) 5.4.1.1 Comparison test
Stop using the whole blood sample with a blood pressure range in Table 1. Before testing each sample, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (P01) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part is tested with high-speed high-speed blood glucose meter after taking out the plasma. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the pulse plasma result tested by the blood glucose meter is as follows: Note: m glucose micro-2.81uw:/L--22,3uurl,L1.1 Comparison test
Discontinue use of whole blood products with a blood glucose level within the range listed in Table 1. Before testing each product, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (POP) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part, after taking out the plasma, uses a blood glucose analyzer for m glucose test. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the venous plasma result tested by the blood glucose analyzer is obtained as follows: m glucose level 2.81uw:/L--22,3uurl,L1.1 Comparison test
Discontinue use of whole blood products with a blood glucose level within the range listed in Table 1. Before testing each product, gently invert it to mix it thoroughly. Adjust the oxygen partial pressure (POP) of the venous blood sample to 3.e?kPu=U.67Pe (65m.mIg±5mrIIg). Weigh each blood sample and divide it into 3 parts. The first part is tested with the first blood glucose meter, the second part is tested with the third blood glucose meter; the eighth part, after taking out the plasma, uses a blood glucose analyzer for m glucose test. The correlation between the intravenous plasma result tested by the blood glucose meter or the conversion formula provided by the manufacturer and the venous plasma result tested by the blood glucose analyzer is obtained as follows: m glucose level 2.81uw:/L--22,3uurl,LCalculate the recovery rate of blood glucose.
R. =g×VVG×V×100y
R-recovery rate;www.bzxz.net
7-1,2,3,4,5,6;
1=2.3.4.5,6.7;
VS, and S: the physiological volume of glucose between two groups: one S, the volume of the accompanying sample:
S, the determination liquid of the sample:
5, the concentration of the sample!
Cs is the concentration of glucose solution prepared,
5.4.2 Test capillary blood samples
5.4.2.1 Test samples
Should be obtained by epidermal acupuncture, such as fingertip, to collect a few different capillary blood samples. The range and number of samples are shown in Table 4. The exclusion criteria, such as blood pressure, should be based on the manufacturer's instructions for use. Sample collection, treatment, disposal and, in some cases, sample handling should be carried out in accordance with the instructions for use. Note: In some cases, a second blood sample may be collected to ensure that the sample is completely separated. 2: The capillary blood sample can be separated according to the method in 5.a> to obtain a capillary blood sample with a minimum blood pressure. 5.4.2.2 Test procedure
First, the capillary blood sample is divided into two equal parts. One of the two equal parts is tested for blood glucose using a blood analyzer according to the standard test procedure on the manufacturer's plate. The other equal part is tested using the two blood samples according to the manufacturer's method. If the test part can only be used to test plasma samples, add the manufacturer's coagulant to one of the equal parts and collect the plasma by centrifugation at 1 or 10 rn. Then, the blood plasma is tested according to the manufacturer's standard measurement procedure. The difference between the whole blood/plasma test result of each blood test strip and the whole blood/plasma test result of the reference analyzer is the deviation.
5.5 Batch Difference of Blood Glucose Test Strips
Use two blood test strips of different batches to measure 30 grams of fresh anticoagulated whole blood or quality control material on a blood glucose meter, and calculate the mean deviation of the two test results. To calculate the total mean of the test results of all three batches, the batch difference is calculated according to the formula ().
5.6 Batch Difference of Control Material
Batch Difference of Control Material (Batch Difference = Large Mean × Small Mean × 10% Total Mean
Use the same blood test strips of the same batch on the same blood glucose meter to measure the blood glucose of the control material 20 times. 5.7 Blood glucose environment test
Test in accordance with the method specified in GB/T11710-993 5. Blood glucose safety test
Test in accordance with the method specified in GB/T11710-993 B4793.-1395 6
6 Labels and instructions for use
6.1 Labels of blood glucose meters
6.1.1 The label of the blood glucose meter shall at least provide the following information: a) Name and address of the manufacturer:
b) Product name and mark (should be marked directly on the label attached to the instrument) CB/T19634-2005
Intended use (including declaration that it is a multi-interval medical device for visual inspection and indication of indication for use with the device): Directly marked on the label attached to the device, etc. 6.1.2 Whenever the above information is used, the symbols used shall comply with the provisions of YY1466: If there is no existing standard for the symbols used, these symbols should be explained in the relevant text of the blood list. 6.2 Instructions for use of blood and positions
6.2.1 Instructions for use should be concise and should be in simple language that is easy for non-professionals to understand. The content of the manual should be well-structured and easy to understand by people without scientific and technical background. The operator's seal should be large and clear, easy to read, and the symbols or instructions should be used as much as possible.
The instructions for use should clearly indicate what to do if the verification shows that the result is invalid. Please use Chinese as the preferred language.
6.2.2 The instructions for use should include the following: Manufacturer's name and address Distributor's name, address and contact information (If the manufacturer is not local, an "authorized representative" is required) a) Name and address of
and
Product name and logo!
) Principle of the test method
) Manufacturer's calibration materials used to establish and evaluate the performance characteristics of the device (if applicable, the manufacturer should provide a clear and detailed description of the materials and/or calibration materials used to establish and evaluate the performance characteristics of the device; details of the type of materials used for calibration, such as whole blood and plasma; the correct test system should be used;
The correct calibration method for the instrument should be used, including
calibration code (such as terminal number, coded test strips, coding, etc.), verification 1. The following are the steps to prepare for the test: the test sequence and the time required (including sample preparation and sample performance), and the detailed steps to be taken after the test: the measurement unit of the instrument report: such as m/s or m/s. The report result is the whole result. The correct measures are recommended when the instrument is wrong. 2. The environment required for the use of the system (such as temperature and humidity range): when selecting, the user must follow the detailed calibration procedure; 3. The following are the detailed quality control procedures, It includes confirmation that the correct quality control materials are used to ensure the normal operation of the blood test system, and the subsequent modifications after the quality control procedures fail. [The type of samples used and the specific sampling and pre-treatment conditions: the precautions that should be taken before use; m
When applicable. The following GB/T19634-2005 standards for the electrical discharge, field and other electrical environment, as well as the environment, humidity and other environmental factors are applied;
All the symbols used in the label instructions are checked. Description or explanation: Recommendations on the measures to be taken based on the measurement results, including: - Consider the guidance of the treating physician and/or diabetes specialist; - Do not follow the guidance of the physician or diabetes specialist before the measurement results are taken; - What to do if the user believes that there is a problem with the measurement results; - How the system will notify the user when the test results fall outside the analysis range (such as error messages, error prompts, etc.); - Regular laboratory checks should be performed to compare the blood test results with the laboratory results. - When applicable, the safety of the system and its components; - When the system and its components are not safe, the system and its components should be handled properly ... The year and month of issue of the instructions for use shall be specified in the version number. 6.3. Labeling of blood glucose test strips and quality control materials 6.3.1 Blood glucose test strips and quality control materials shall be labeled. The label shall also include the following: a) Name and address of manufacturer b) Name, model or trademark of blood glucose test strips and quality control materials r) Preferred use and applicable glucose meter d) Instructions for use of "In vitro clinical test" 6) Storage case: R) Approval: Expiration date: Expiration date or expiration date after opening the package: Please refer to the description in the instructions for use. |The standard should be set up on the test device and there should be instructions on the plan for random blood test and the handling of the blood test to ensure the full quantity of sales and the safety of the buried.
6.3.2 Chinese should be used. Other languages ​​may also be used. 4 Instructions for use of blood test strips and quality control substances 6.4.1 The instructions for use of blood test strips and quality control substances should include the following elements: a) The name, address and customer service of the manufacturer and/or distributor: a) The blood test strips and quality control substances: a) Storage conditions (such as visibility, brightness, light, and other environmental conditions) (including the cover required by the seller) Tighten the cover of the device to avoid passing gas through the tube
) Measurement range + including the concentration limit and lower limit of the blood auxiliary results that can be reported with a positive deviation, "For in vitro monitoring only" instructions:
): Performance characteristics (such as system accuracy changes) that can be understood by the expected user. When manufacturing, the system accuracy characteristics are reported in the following manner:
-When the powder concentration is 1,2mmo1/1. (75mg/dL), the deviation from the expected value is within ±0.28mmol/L±c56mmul/L±0.83uu[/T (± $mg/ll.=1mg/l±15mg/ll.) score within the range:
1. Blood glucose level 24.2mml/L (75mg/L. Deviation from the test value will be 5%, +10%.=15%120% score within the range:
) 2. Any disturbing substances (such as hemoconstriction, jaundice, lipemia) or physiological factors that may affect the accuracy of the sampling (such as extracorporeal circulation) are present:
Used to evaluate the performance characteristics of the system, and can be used to give a higher technical level.
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