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JJF 1945-2021 English PDF

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US$439.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
JJF 1945-2021: Calibration Specification for Blood Coagulation Analyzers
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1945-2021	439	Add to Cart	4 days	Calibration Specification for Blood Coagulation Analyzers	Valid

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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)

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of JJF 1945-2021_English be delivered?

Answer: Upon your order, we will start to translate JJF 1945-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of JJF 1945-2021_English with my colleagues?

Answer: Yes. The purchased PDF of JJF 1945-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.