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Clinical investigation of medical devices
Basic information
Standard No：YY/T 0297-1997
Standard Name：医疗器械临床调查
English Name：Clinical investigation of medical devices
Standard Status：被代替
Release Date：1997-08-27
Effective Date：1998-01-01
Language of Publication：中文简体
Standard Classification
CCS Number：C30
Related Standards
Referenced Standards：世界医学协会赫尔辛基宣言 医生进行包括人体对象在内的生物医学研究指南(见附录A)
Adopted Standards：ISO 14155:1996
Adoption Level：IDT
Publication Information
Number of pages：16
Number of words：22 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：1998-01-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家医药管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0297
Drafter：吴平、常骅、吕建民、田青
Drafting Organization：国家医药管理局医疗器械行政监督司、国家医药管理局医用高分子产品质量检测中心
Management Organization：全国医疗器械生物学评价标准化技术委员会
Proposing Department：国家医药管理局
