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Chinese Standard: YY/T 0489-2023

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Sterile drainage catheters and accessory devices for single use


Standard in brief
Scope of Application:  
本文件规定了一次性使用无菌的引流导管、伤口和积液引流系统、手术引流导管和有关组件的要求,其中导管以手术或经皮方式放置于体腔或伤口中,用于将液体或空气引流到体外。引流导管留作自然引流或连接至吸引源(以加快组织肉芽形成)。本文件不适用于:--抽吸导管;--气管导管;--导尿管;注

Basic information
Standard No:YY/T 0489-2023
Standard Name:一次性使用无菌引流导管及辅助器械
English Name:Sterile drainage catheters and accessory devices for single use
Standard Status:现行
Release Date:2004-07-16
Effective Date:2024-12-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.40
CCS Number:C45

Related Standards
Referenced Standards:GB/T 14233.1,GB/T 16886.1,YY/T 0615.1,YY/T 0916.1
Adopted Standards:ISO 20697:2018
Adopted Standard Name:《一次性使用无菌引流导管及辅助器械》
Adoption Level:MOD

Publication Information
Number of pages:36
Number of words:70 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2023-12-01

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:0489
Drafter:万敏、李元彧、徐浩宇、王万明、张海军、石凯、刘爱娟、栾园园、朱艺馨
Drafting Organization:山东省医疗器械和药品包装检验研究院、江苏扬子江医疗科技股份有限公司、北京天地和协科技有限公司、山东百多安医疗器械股份有限公司、巴德医疗科技(上海)有限公司
Management Organization:全国医用输液器具标准化技术委员会(SAC/TC 106)
Proposing Department:国家药品监督管理局

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