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Chinese Standard: YY/T 0450.3-2016

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Accessory devices for sterile single-use intravascular catheters—Part 3:Inflation devices for balloon of balloon dilatation catheters


Standard in brief
Scope of Application:  
YY/T 0450的本部分规定了血管内球囊扩张导管用一次性使用手动式充压装置(简称“充压装置”)的要求,该产品适用于对YY 0285.4所规定的球囊扩张导管的球囊打压,使其膨胀从而达到扩张血管或释放支架的目的。
血管内栓塞的释放装置和球囊阻断导管的充压装置具有与本部分所规定的充压装置相类似的结构。本标准对这些装置不适用。

Basic information
Standard No:YY/T 0450.3-2016
Standard Name:一次性使用无菌血管内导管辅件 第3部分:球囊扩张导管用球囊充压装置
English Name:Accessory devices for sterile single-use intravascular catheters—Part 3:Inflation devices for balloon of balloon dilatation catheters
Standard Status:现行
Release Date:2007-07-02
Effective Date:2017-06-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.120.30
CCS Number:C31

Related Standards
Referenced Standards:GB/T 1962.2,GB 9706,GB 15810,GB/T 16886.1,GB/T 19633.1-2015,YY 0505,YY/T 0615.1

Publication Information
Number of pages:20
Number of words:30 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-04-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0450.3
Drafter:白冰、陈慧敏、唐洁、万敏
Drafting Organization:山东恒信检测技术开发中心、美敦力(上海)管理有限公司、深圳市益心达医学新技术有限公司、山东省医疗器械产品质量检验中心
Management Organization:国家食品药品监督管理局济南医疗器械质量监督检验中心

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