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Chinese Standard: YY/T 0677-2008

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Liquid nitrogen cryosurgical equipment


Standard in brief
Scope of Application:  
本标准规定了液氮冷冻外科治疗设备的范围、定义和术语、要求、试验方法、检验规则及标志、标签、包装等要求。
本标准适用于制冷剂为液氮,利用其汽化相变潜热制冷,且液氮存贮器容量大于1 L的冷冻外科治疗设备(以下简称治疗设备)。治疗设备主要对靶组织产生低温,用于冷冻坏死、冷冻阻滞、炎性反应及冷冻粘连用。

Basic information
Standard No:YY/T 0677-2008
Standard Name:液氮冷冻外科治疗设备
English Name:Liquid nitrogen cryosurgical equipment
Standard Status:现行
Release Date:2008-10-17
Effective Date:2010-06-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.60
CCS Number:C37

Related Standards
Referenced Standards:GB 9706.1,GB/T 14710-1993,GB/T 16886.1,YY 0466-2003,YY 0678,医疗器械说明书、包装标识和标签的管理规定 国家食品药品监督管理局 第10号令

Publication Information
Number of pages:12
Number of words:12 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:0677
Drafter:吕维敏、尹建兵、唐立、孙瑜、章忠敏、马莉
Drafting Organization:浙江省医疗器械研究所、浙江省医疗器械检验所
Management Organization:国家食品药品监督管理局杭州医疗器械质量监督检验中心
Proposing Department:国家食品药品监督管理局杭州医疗器械质量监督检验中心

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