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YY/T 0658-2008 English PDF

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YY/T 0658-2008: Semi-automated coagulation analyzer
Status: Obsolete
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YY/T 0658-2008English359 Add to Cart 3 days [Need to translate] Semi-automated coagulation analyzer Obsolete YY/T 0658-2008

PDF similar to YY/T 0658-2008


Standard similar to YY/T 0658-2008

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Basic data

Standard ID YY/T 0658-2008 (YY/T0658-2008)
Description (Translated English) Semi-automated coagulation analyzer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 9,923
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; YY 0466-2003; YY 0648-2008
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the semi-automatic coagulation analyzer terminology and definitions, classification and composition requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to blood clotting and coagulation, fibrinolytic and anti- fibrinolytic function analysis of automatic coagulation analyzer. This standard specifies the instruments used to detect prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT) detection of the technical requirements for blood clotting factor, D-dimer (D-dimer) and other testing of the technical requirements are not specified in this standard.

YY/T 0658-2008: Semi-automated coagulation analyzer

---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.
Semi-automated coagulation analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Semi-automatic blood coagulation analyzer Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was proposed by the State Food and Drug Administration. This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee. This standard is mainly drafted by. Sysmex Medical Electronics (Shanghai) Co., Ltd., Beijing Medical Device Testing, Sida high diagnostic technology Limited surgery, PLA General Hospital. The main drafters of this standard. Li Lin, PENG Li-ming, continued Yong, Zhang, Tang Xiaomei, He Xueying, Deng Xinli. Semi-automatic blood coagulation analyzer

1 Scope

This standard specifies the semi-automatic blood coagulation analyzer of terms and definitions, classification and composition requirements, test methods, marking, labeling, instructions for use Books, packaging, transportation and storage. This standard applies to blood coagulation and anticoagulation, fibrinolysis and antifibrinolytic functional analysis automatic coagulation analyzer. This standard specifies Instrument for detecting prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin Time (TT) detection of the technical requirements for blood clotting factor, the technical requirements of D-dimer (D-dimer) and other testing is not specified in this standard.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 191 Packaging - Pictorial signs GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements GB/T 14710 Medical electrical equipment environmental requirements and test methods YY 0466-2003 medical equipment used with medical device labels, signs and symbols provide information (ISO 15223.2000, IDT) YY 0648-2008 measurement, control and laboratory use - Part 2-101 safe electrical equipment. in vitro diagnostic medical devices designed With requirements (IEC 61010-2-101.2002, IDT)

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 Liquid sample can be used for the determination of the detection system, including calibrators, controls, and other fresh plasma or whole blood. 3.2 Applied to the instrument or system characteristics. During the analysis, some of the processes to achieve mechanization, while others require the operator to complete the process. 3.3 In a measurement cycle, the reaction solution can be detected and the detection result obtained in the reaction unit. 3.4 Simulated physiological conditions of blood coagulation, adding some reagents, start blood coagulation reaction, fibrinogen in the sample is converted to crosslinked fibers Dimensional protein so that the sample coagulation. Through continuous monitoring of the optical system of the reaction process occurs (eg absorbance), physics (for example, Viscosity) or electricity (such as current) characteristic change determining end of the reaction, and as fibrinogen conversion time, using this principle the determination of blood Solidifying liquid sample or fibrinolytic properties characteristic way. 3.5 Synthetic compounds have some cleavage site (such as phenylalanine - valine - arginine amide, Phe-Val-Arg) with a chromogenic substance

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