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Chinese Standard: YY/T 0860-2024

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Radio frequency ablation instrument for cardiac application


Standard in brief
Scope of Application:  
本文件规定了心脏射频消融治疗设备(以下简称设备)及其配用附件的分类、要求,描述了相应的试验方法。
本文件适用于心脏射频消融治疗设备及其配用附件,该类设备用于心脏介入射频消融手术或心/胸外科射频消融手术。

Basic information
Standard No:YY/T 0860-2024
Standard Name:心脏射频消融治疗设备
English Name:Radio frequency ablation instrument for cardiac application
Standard Status:现行
Release Date:2011-12-31
Effective Date:2025-10-15
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.60
CCS Number:C42

Related Standards
Referenced Standards:GB 9706.1,GB 9706.202,GB/T 14233.1,GB/T 14233.2,GB/T 14710,GB/T 16886.1,GB/T 16886.7,YY 0650,YY 0778,YY/T 1057

Publication Information
Number of pages:16
Number of words:17 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2024-10-01

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:0860
Drafter:张龙飞、刘博、孙惠丽、李雅楠、许伟、洪伟、陆凌峰、单莹、谭小柳、索银虎、张小华
Drafting Organization:天津市医疗器械质量监督检验中心、上海市医疗器械检验研究院、强生(上海)医疗器材有限公司、美敦力(上海)管理有限公司、北京佰仁医疗科技股份有限公司、四川锦江电子医疗器械科技股份有限公司
Management Organization:全国医用电器标准化技术委员会物理治疗设备分技术委员会(SAC/TC 10/SC 4)
Proposing Department:国家药品监督管理局

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