YY/T 0658-2008 Replaced Industry standards-Medicine

YY/T 0658-2008 Semi-automated coagulation analyzer

YY/T 0658-2008 Semi-automated coagulation analyzer

Publish Date: 2008-04-25 Implement Date: 2009-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0658-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2008-04-25

Implement Date: 2009-06-01

Pages: 8 pages

Scope

This standard specifies the terms and definitions, classification and composition, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of semi-automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers used for analyzing coagulation, anticoagulation, fibrinolysis, and anti-fibrinolysis functions in blood. The standard specifies the technical requirements for instruments used to detect plasma prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT). Technical requirements for the detection of coagulation factors and D-dimer are not specified in this standard.

Development Information

Word Count: 11 Thousand words Pages: 8 pages

Superseded by the following standards

YY/T 0659-2017 Blood coagulation analyzer

Referenced Standards

YY 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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