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Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Basic information
Standard No：YY/T 0690-2008
Standard Name：临床实验室测试和体外医疗器械 口服抗凝药治疗自测体外监测系统的要求
English Name：Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Standard Status：现行
Release Date：2008-10-17
Effective Date：2010-01-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.100.20
CCS Number：C44
Related Standards
Referenced Standards：GB 4793.1,GB/T 17626.2,GB/T 17626.3,GB/T 18268,GB/T 21415,YY/T 0287,YY/T 0316,ISO 15198,ISO 18113-1,ISO 18113-4,ISO 18113-5,IEC 60068-2-64:1993,IEC 61010-2-101:2002,EN 13532:2002,EN 13612,EN 13640,WHO技术报告丛书(No.889,1999) 附录3 用于控制口服抗凝药治疗的凝血活酶和血浆的指导术语和定义
Adopted Standards：ISO 17593:2007
Adopted Standard Name：《临床实验室测试和体外医疗器械 口服抗凝药治疗自测体外监测系统的要求》
Adoption Level：IDT
Publication Information
Number of pages：52
Number of words：85 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2009-05-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0690
Drafter：杨宗兵、毕春雷、贺学英
Drafting Organization：北京市医疗器械检验所
Management Organization：全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Proposing Department：全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
