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Chinese Standard: YY/T 1660-2019

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Guide for radial loading of balloon expandable andself expanding vascular stents


Standard in brief
Scope of Application:  
本标准规定了开发测量球囊扩张血管支架径向强度或塌陷压力及自扩张血管支架慢性外展力的体外试验方法的指导原则。本标准适用于管状结构的球囊扩张和自扩张支架。本标准适用于裸支架和覆膜支架,但不适用于分叉支架及非圆截面的支架或锥形支架。

Basic information
Standard No:YY/T 1660-2019
Standard Name:球囊扩张和自扩张血管支架的径向载荷测试方法
English Name:Guide for radial loading of balloon expandable andself expanding vascular stents
Standard Status:现行
Release Date:2019-07-24
Effective Date:2020-08-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.40
CCS Number:C35

Related Standards
Referenced Standards:GB/T 10623-2008,GB/T 16825.1-2008,YY/T 0694-2008,YY/T 0808-2010

Publication Information
Number of pages:32
Number of words:54 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2019-08-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1660
Drafter:缪辉、张争辉、樊铂、李勇、孙冰、许佳佳、蒋波、胡广勇、苏健
Drafting Organization:天津市医疗器械质量监督检验中心、上海微创医疗器械(集团)有限公司、乐普(北京)医疗器械股份有限公司、北京市医疗器械检测所
Management Organization:全国外科植入物和矫形器械标准化技术委员会心血管植入物分技术委员会(SAC/TC 110/SC 2)
Proposing Department:国家药品监督管理局

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