YY/T 0659-2008 in English

本标准规定了全自动凝血分析仪的术语和定义、分类和组成、要求、试验方法 、标志、标签、使用说明书、包装、运输和贮存；
本标准适用于对血液进行凝血和抗凝、纤溶和抗纤溶功能分析的全自动凝血分析仪。
本标准规定了仪器用于检测血浆凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）、凝血酶时间（TT）检测的技术要求，用于凝血因子、D二聚体（D-dimer）等检测的技术要求未在本标准中规定。

Scope

This standard specifies the terms and definitions, classification and composition, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of fully automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers that perform coagulation, anticoagulation, fibrinolysis and antifibrinolysis function analysis on blood. This 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). It is used for coagulation factors, The technical requirements for D-dimer and other tests are not specified in this standard.