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JJF 1945-2021: Calibration Specification for Blood Coagulation Analyzers
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Calibration Specification for Blood Coagulation Analyzers
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JJF 1945-2021
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Standard similar to JJF 1945-2021 JJF 1033 JJF 1050 JJF 1030 Basic data | Standard ID | JJF 1945-2021 (JJF1945-2021) | | Description (Translated English) | Calibration Specification for Blood Coagulation Analyzers | | Sector / Industry | Metrology & Measurement Industry Standard | | Word Count Estimation | 19,166 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 1945-2021: Calibration Specification for Blood Coagulation Analyzers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Calibration Specification for Blood Coagulation Analyzers
National Metrology Technical Specification of the People's Republic of China
Coagulation Analyzer Calibration Specifications
Published on 2021-12-28
2022-06-28 Implementation
Released by the State Administration for Market Regulation
Coagulation Analyzer Calibration Specifications
zers
Focal Point. National Biometric Technology Committee
Main drafting unit. China Institute of Metrology
Jiangsu Institute of Metrology
Nanjing Metrology Supervision and Inspection Institute
Participating in the drafting unit. Shanghai Institute of Metrology and Testing Technology
This specification is entrusted to the National Biometric Technology Committee to be responsible for the interpretation
The main drafters of this specification.
Mi Wei (China Institute of Metrology)
Cui Hongen (Jiangsu Institute of Metrology)
Chen Hongfei (Nanjing Metrology Supervision and Inspection Institute)
Participating drafters.
Sheng Linghui (China Institute of Metrology)
Huang Tianhao (Shanghai Institute of Metrology and Testing Technology)
Table of contents
Introduction (Ⅱ)
1 Scope(1)
2 References (1)
3 Terms (1)
3.1 Reaction system (1)
3.2 Channel(1)
4 Overview(1)
5 Metrology Characteristics(1)
6 Calibration Conditions(2)
6.1 Environmental conditions (2)
6.2 Calibration equipment and reagents(3)
7 Calibration items and calibration methods (3)
7.1 Temperature control(3)
7.2 Channel difference(3)
7.3 Carrying pollution rate (4)
7.4 Measurement repeatability(4)
7.5 FIB relative indication error (5)
7.6 FIB linearity(5)
8 Expression of calibration results (5)
8.1 Calibration result processing(5)
8.2 Temperature and FIB calibration uncertainty(5)
9 Recalibration interval(6)
Appendix A Calibration Raw Record (Reference) Format(7)
Appendix B Calibration Certificate Results Page (Reference) Format (9)
Appendix C Temperature and FIB Calibration Uncertainty Evaluation Example(10)
Introduction
JJF 1071 "Rules for the Compilation of National Metrology Calibration Specifications", JJF 1001 "General Metrology Terms and Definitions" and
JJF 1059.1 "Assessment and Representation of Measurement Uncertainty" together constitute the basic series of regulations supporting the formulation of this specification.
Fan. The calibration method and measurement characteristics mainly refer to JJF 1101-2019 "Temperature and Humidity Calibration of Environmental Test Equipment"
Specification", YY/T 0659-2017 "Coagulation Analyzer" and CLSIH30-A2 Determination of Fibrinogen in Plasma
Approvedguideline-secondedition).
This specification gives the relative indication error according to JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Representation"
Example of measurement uncertainty and evaluation of calibration results.
This specification is published for the first time.
Coagulation Analyzer Calibration Specifications
1 Scope
This standard applies to the clinical analysis of blood coagulation and anticoagulation, fibrinolysis and antifibrinolysis of patients.
Calibration of coagulation analyzers, not suitable for platelet aggregation function and blood flow function testing, point-of-care testing (POCT)
calibration of the instrument.
2 Reference documents
This specification references the following documents.
JJF 1101-2019 Specification for temperature and humidity calibration of environmental test equipment
YY/T 0659-2017 Coagulation analyzer
CLSIH30-A2 Methodology Approval Guide for the Determination of Fibrinogen in Plasma—Second Edition (Procedure
For dated references, only the dated version applies to this specification; for undated references
The latest version (including all amendments) applies to this specification.
3 Terminology
Terms and definitions as defined in JJF 1101-2019, YY/T 0659-2017 and CLSIH30-A2 and the following
apply to this specification.
3.1 reaction system reactionsystem
The liquid phase system consisting of the sample and the added reagents is included to obtain sample-related parameters.
3.2 Channel channel
In one measurement cycle, the channel that can detect the reaction system and obtain the detection result.
4 Overview
The coagulation analyzer (hereinafter referred to as the analyzer) is a system used for the detection of coagulation, anticoagulation and fibrinolysis.
It can be used for the diagnosis and differential diagnosis of hemorrhagic and thrombotic diseases, monitoring and curative effect of anticoagulation and thrombolytic therapy
Observations provide valuable metrics. The detection items of the coagulation analyzer should at least include PT, APTT, FIB, TT
Determination. The analyzer is divided into coagulation method, chromogenic substrate method and immunoturbidimetric method according to the test method.
The degree is divided into semi-automatic analyzers and fully automatic analyzers. Semi-automatic analyzers are divided into two categories according to the number of samples that can be detected at the same time.
Single and multi-channel analyzers.
Semi-automatic analyzers are generally composed of detection units, control units, data processing, display and printing units. Complete
The automatic analyzer generally consists of automatic sampling unit, detection unit, control unit, data processing, display and printing unit, etc.
composition.
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