Standard No.:	YY/T 0659-2017
English Name:	Blood coagulation analyzer
Chinese Name:	凝血分析仪
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2017-03-28
Implemented on:	2018-4-1
Status:	superseded
Superseded by:	YY/T 0659-2017/XG1-2022 Blood coagulation analyzer, includes Amendment 1
Superseded on:	2022-10-17
Superseding:	YY/T 0658-2008 Semi-automated coagulation analyzer YY/T 0659-2008 Automated coagulation analyzer
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	140.0
Delivery:	via email in 1~3 business day

本标准规定了凝血分析仪的术语和定义、产品分类、技术要求、试验方法、标签、标记和使用说明、包装、运输和贮存要求。
本标准适用于临床上用于对患者的血液进行凝血和抗凝、纤溶和抗纤溶功能分析的凝血分析仪。
本标准不适用于血小板聚集功能和血流变功能检测、即时检测（POCT）的仪器。