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YY/T 0658-2008Semi-automated coagulation analyzer (English PDF)

半自动凝血分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

June 1, 2009

Scope

YY/T 0658-2008 is the English-translated version of 半自动凝血分析仪.

YY/T 0658-2008 sets the product requirements for semi-automatic blood coagulation analyzers used to study clotting, anticoagulation, fibrinolysis and antifibrinolytic function.

Besides terms and definitions such as sample, test channel, clotting method and chromogenic substrate, it deals with how the instruments are classified and built, the requirements they must meet and the test methods that check them, followed by marking, labels, instructions for use, packaging, transport and storage.

The technical requirements concern instruments that measure prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB) and thrombin time (TT).

Requirements for coagulation factor assays, D-dimer and other tests fall outside it. Electrical safety is handled by reference to GB 4793.1 and YY 0648-2008. The standard was issued on 25 April 2008 and has been in force since 1 June 2009.

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Document preview — YY/T 0658-2008

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

1 Scope
2 Normative references
3 Terms and Definitions

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 Sample

Liquid sample can be used for the determination of the detection system, including calibrators, controls, and other fresh plasma or whole blood.

3.2 Semi-automatic

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 Test channel

In a measurement cycle, the reaction solution can be detected and the detection result obtained in the reaction unit.

3.4 Clotting method

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 Chromogenic substrate

Synthetic compounds have some cleavage site (such as phenylalanine - valine - arginine amide, Phe-Val-Arg) with a chromogenic substance.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0659-2017|YY/T 1174-2010|YY/T 1745-2021|GB/T 33862-2017

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