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YY/T 0864-2011

标准搜索结果: 'YY/T 0864-2011'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 0864-2011 英文版 355 购买 现货,9秒内自动发货PDF,有增值税发票。 医用内窥镜 内窥镜功能供给装置 液体膨腔泵 有效

   
标准详细信息 YY/T 0864-2011; YY/T0864-2011; YYT 0864-2011; YYT0864-2011
中文名称: 医用内窥镜 内窥镜功能供给装置 液体膨腔泵
英文名称: Medical endoscopes - Endoscope functional supply units - Irrigation pump
行业: 医药行业标准 (推荐)
中标分类: C40
国际标准分类: 11.040.99
字数估计: 9,000
发布日期: 2011-12-31
实施日期: 2013-06-01
引用标准: GB 9706.1-2007; GB 9706.19-2000; GB/T 14233.2-2005; GB/T 14710-2009; GB/T 16886.1-2011; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; YY 0709-2009
起草单位: 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、浙江省医疗器械检验所
归口单位: 全国医用光学和仪器标准化分技术委员会(SAC/TC 103/SC 1)
标准依据: 国家食品药品监督管理局公告2011年第106号
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: 本标准规定了对医用内窥镜用液体膨腔泵(以下简称膨腔泵)的要求。本标准适用于内窥镜手术所使用的膨腔泵。该产品用于微创内窥镜手术中的膨腔。

YY/T 0864-2011
Medical endoscopes - Endoscope functional supply units - Irrigation pump
ICS 11.040.99
C40
中华人民共和国医药行业标准
医用内窥镜 内窥镜功能供给装置
液体膨腔泵
Irrigationpump
2011-12-31发布
2013-06-01实施
国家食品药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理局提出。
本标准由全国医用光学和仪器标准化分技术委员会(SAC/TC103/SC1)归口。
本标准起草单位: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、浙江省医疗器械检
验所。
本标准主要起草人:颜青来、贾晓航、何涛、齐伟明、张沁园、郑建。
医用内窥镜 内窥镜功能供给装置
液体膨腔泵
1 范围
本标准规定了对医用内窥镜用液体膨腔泵(以下简称膨腔泵)的要求。
本标准适用于内窥镜手术所使用的膨腔泵。该产品用于微创内窥镜手术中的膨腔。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 9706.1-2007 医用电气设备 第1部分:安全通用要求
GB 9706.19-2000 电气设备 第2部分:内窥镜设备安全专用要求
GB/T 14233.2-2005 医用输液、输血、注射器具检验方法 第2部分:生物学试验方法
GB/T 14710-2009 医用电器环境要求及试验方法
GB/T 16886.1-2011 医疗器械生物学评价 第1部分:风险过程中的评价与试验
GB/T 16886.5-2003 医疗器械生物学评价 第5部分:体外细胞毒性试验
GB/T 16886.7-2001 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量
GB/T 16886.10-2005 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验
YY0709-2009 医用电气设备 第1-8部分:安全通用要求 并列标准:通用要求 医用电气设
备和医用电气系统中报警系统的测试和指南
3 术语和定义
下列术语和定义适用于本文件。
3.1
内窥镜功能供给装置 endoscopefunctionalsupplyunits
在微创内窥镜诊断和(或)治疗/手术中,提供支持功能的装置或设备。
4 要求
4.1 压强限
4.1.1 预置压强限的调节范围
若膨腔泵的预置压强限可调,制造商应给出预置压强限的调节范围,并应与膨腔泵的预置压强限的
实际调节范围一致。
4.1.2 压强限预置的准确性
当设置压强限≥6650Pa(50mmHg)时,压强限设置的允差为±5%;当设置压强限<6650Pa

YY/T 0864-2011
Translated English of Chinese Standard. YY/T0864‐2011 
YY
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Medical endoscopes - Endoscope functional
supply units - Irrigation pump
医用内窥镜 内窥镜功能供给装置液体膨腔泵
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Terms and definitions ... 5 
4  Requirements ... 5 
5  Test methods ... 7 
Foreword 
This Standard is drafted according to the rules specified in GB/T 1.1-2009
Please note that some contents in this document may involve in patents. The issuing
authority of this document will not be responsible to identify these patents.
This Standard was proposed by China's State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Sub-committee
(SAC/TC 103/ SC 1) on Medical Optical and Instrument of Standardization Administration
of China.
Drafting organizations of this Standard. Hangzhou Medical Equipment Quality Supervision
and Inspection Center of State Food and Drug Administration, and Zhejiang Medical
Equipment Inspection Center.
The main drafting staffs of this standard. Yan Qinglai, Jia Xiaohang, He Tao, Qi Weiming
Zhang Qinyuan, and Zheng Jian.
Medical endoscopes - Endoscope functional supply
units - Irrigation pump
1  Scope 
This Standard specifies the requirements for the irrigation pump that is used for medical
endoscope.
This Standard applies to irrigation pump that is used in endoscope surgery. It is used for
the irrigation in the minimally invasive endoscope surgery.
2  Normative references 
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for
safety
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for
the safety of endoscopic equipment
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for
medical use - Part 2. Biological test methods
GB/T 14710-2009 Environmental requirement and test methods for medical electrical
equipment
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and
testing within a risk management process
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test for in vitro
cytotoxicity
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide
sterilization residuals
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for
irritation and delayed-type hypersensitivity
Connect the irrigation pumps with pipelines, and supply water source according to the
provisions in the attached information.
After the connection between the pipeline outlet and the pressure buffer, connect the
hydraulic pressure gauge.
Control the power supply of the irrigation pump to maintain it stable at the nominal voltage.
This voltage shall be monitored. The voltage stability shall be controlled within ± 2%.
After the completion of the starting self-check procedure of the irrigation pump, it shall
show that each component works normally.
5.1.2.2.2 Measurement procedure
the irrigation pump is adjustable, set the flow of the irrigation pump to the maximum value.
Start to inject in liquid. Read the actual pressure on the hydraulic pressure gauge after it is
stabilized, expressed as pr.
If the setting pressure limit on the irrigation pump is adjustable, ps shall at least take the
highest value, medium value, and the lowest value but not less than 3999Pa (30mmHg).
Measure 3 times for each test point. Take the average value as the measurement result pr.
5.1.2.3 Results representation
The deviation of the pressure limit setting is expressed in the maximum deviation between
the actual pressure and the setting pressure limit, expressed as Aps.
The result shall indicate the ps, pr and Aps values, when the ps is respectively the 3 values
set in 5.1.2.2.2.
5.1.3 Determination of overvoltage and reduced-pressure function and
overpressure alarm function
5.1.3.1 Device
5.1.3.1.1 Hydraulic pressure gauge
Same as 5.1.2.1.
5.1.3.1.2 Elastic cysts
It can collect liquid, with elasticity. It has 2 interfaces - of which one can be connected to
pressure gauge to measure the actual hydraulic pressure in the elastic cysts.
5.2.2.1.2 Timer
The accuracy shall be within 0.1s.
5.2.2.2 Steps
5.2.2.2.1 Preparatory work
Connect the irrigation pumps with pipelines, and supply water source according to the
provisions in the attached information.
The outlet of the pipeline is connected with the container of measuring liquid volume.
Control the power supply of the irrigation pump to maintain it stable at the nominal voltage.
After the completion of the starting self-check procedure of the irrigation pump, it shall
show that each component works normally.
5.2.2.2.2 Measurement procedure
This test is conducted under the state that the end of the pipeline is opened.
Set the setting pressure limit on the irrigation pump to the highest value. Set the setting
flow on the irrigation pump, expressed as Ls.
Start to inject in liquid. Stop the liquid injection after t min. Measure the volume of injected
liquid at the pipeline outlet, expressed as V.
Obtain the actual flow Lr through calculation by Formula Lr = V/t.
highest value, medium value and the lowest value within the flow range but not less than
50mL/min (0.003m3/h). Measure 3 times for each test point. Take the average value as the
measurement result Lr.
5.2.3 Results representation
The deviation of the setting flow is expressed in the maximum deviation between the
actual flow and the setting flow, expressed as ALs.
When the setting flow is ≥100mL / min (0.006m3/h), ALs is expressed in relative value, i.e.
ALs = (Lr - Ls)/ Ls. When the he setting flow is < 100mL / min (0.006m3/h), ALs is expressed
in absolute value, i.e. ALs=Lr - Ls.
set in 5.2.2.2.2.
5.3 Test of the pipeline
9706.19-2000.
5.5 Environmental test
The mechanical environmental tolerance test shall be conducted according to provisions
of Mechanical Environment Group II in GB/T 14710-2009.
Climatic environmental tolerance test shall be conducted in accordance with GB/T
14710-2009.
   
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