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Standard guide for characterization and presentation of the dimensional attributes of vascular stents
Standard in brief
Scope of Application:
1.1 本标准包含了与临床性能有效性相关的血管假体尺寸属性的识别及推荐的检测方法。本标准还包
括支架放置过程中输送系统的包装和特殊标识。
1.2 本标准仅指出了支架的尺寸特性。这里并没有指出支架的材料性能及功能特性。本标准中描述的
所有尺寸特性指的是体外试验(“实验台”)特性。由于患者的各种因素,如血管顺应性,实际的体内试验特性可能有微小差异。
Basic information
Standard No:YY/T 0693-2008
Standard Name:血管支架尺寸特性的表征
English Name:Standard guide for characterization and presentation of the dimensional attributes of vascular stents
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:11.040.40
CCS Number:C35
Related Standards
Referenced Standards:YY 0285.1,YY 0285.4
Adopted Standards:ASTM F 2081-06
Adopted Standard Name:《血管支架尺寸特性的表征》
Adoption Level:MOD
Publication Information
Number of pages:12
Number of words:13 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2009-01-01
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:0693
Drafter:杨建刚、董双鹏、李立宾、樊铂
Drafting Organization:国家食品药品监督管理局天津医疗器械质量监督检验中心
Management Organization:全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Proposing Department:全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)