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Establishment and verification of detection capability for clinical laboratory measurement procedures
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Basic data
| Standard ID | WS/T 514-2017 (WS/T514-2017) |
| Description (Translated English) | Establishment and verification of detection capability for clinical laboratory measurement procedures |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Classification of International Standard | 11.020 |
| Word Count Estimation | 24,223 |
| Date of Issue | 2017-01-15 |
| Date of Implementation | 2017-07-01 |
| Quoted Standard | GB/T 20470-2006; WS/T 403-2012 |
| Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China |
| Summary | This standard specifies the technical requirements and operation of the establishment and verification of the detection ability of clinical test methods. This standard applies to the user to establish and verify the detection of clinical testing methods. |
WS/T 514-2017: Establishment and verification of detection capability for clinical laboratory measurement procedures
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Establishment and verification of detection capability for clinical laboratory measurement procedures
ICS 11.020
C50
People's Republic of China health industry standards
Clinical testing methods to establish the ability and verification
2017-01-15 Posted
2017-07-01 implementation
People's Republic of China National Health and Family Planning Commission released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Tongji Medical College Affiliated Tongji Hospital, Huazhong University of Science and Technology, Beijing Civil Aviation General Hospital, Chinese Academy of Medical Sciences Beijing
Concord Hospital, Capital Medical University affiliated Beijing Tongren Hospital, Ministry of Health Clinical Laboratory.
The main drafters of this standard. Guan Qing, Wang Xuejing, Qiu Ling, Liu Xiang, Zhang Bao, Li Huijun.
Clinical testing methods to establish the ability and verification
1 Scope
This standard specifies the clinical testing methods to detect the ability to establish and verify the technical requirements and operational procedures.
This standard applies to the user to establish and verify the detection of clinical testing methods.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Clinical Laboratory Room Quality Assessment Requirements
WS/T 403-2012 clinical biochemical tests routine project quality indicators
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Referencevalue
Used as a basis for comparison with similar quantities.
Note. The reference value can come from.
a) Theoretical or deterministic values based on scientific principles;
b) Designation or certification values based on experimental work carried out in some countries or international organizations;
c) agreed or certified values based on collaborative experimental work sponsored by science or engineering organizations;
d) When a), b), c) are not available, the expected value of the (measurable) quantity is used, which is the mean of the measurement population.
3.2
Accuracy accuracy
The degree of agreement between the measured value and its true value.
NOTE 1 When the term "accuracy" is used for a set of measurements, it consists of a random error component and a systematic error, ie, an offset component;
Note 2. In medical laboratory measurement, the true value refers to the reference value.
3.3
Offset bias
System measurement error estimate.
Note. The offset is used to measure the correctness, which is the difference between the expected value of the measurement and the reference value.
3.4
Blank
No analytes or samples at least below the lowest meaningful level.
3.5
Blank limitofblank
The highest possible measurement that can be observed when measuring blank samples.
Note. Not the concentration of the actual analyte in the sample, the blank margin is also called the critical value of the netstate variable.
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