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YY 0843-2011

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YY 0843-2011 英文版 810 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 气腹机 有效

   
标准详细信息 YY 0843-2011; YY0843-2011
中文名称: 医用内窥镜 内窥镜功能供给装置 气腹机
英文名称: Medical endoscopes - Endoscope supply units - Insufflators
行业: 医药行业标准
中标分类: C40
国际标准分类: 11.040.99
字数估计: 12,000
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
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;行业标准备案公告2013年第6号(总第162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二氧化碳气腹机的要求和试验方法。本标准适用于内窥镜手术所使用的二氧化碳气腹机。该产品用于微创内窥镜手术中的气腹建立和维持。

YY 0843-2011
Medical endoscopes - Endoscope supply units - Insufflators
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
气腹机
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、张沁园、毛欣欣。
医用内窥镜 内窥镜功能供给装置
气腹机
1 范围
本标准规定了对医用内窥镜用二氧化碳气腹机的要求和试验方法。
本标准适用于内窥镜手术所使用的二氧化碳气腹机。该产品用于微创内窥镜手术中的气腹建立和
维持。
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
3 要求
3.1 接口规格
气腹机与外气源连接的进气接口形式及连接螺纹应符合GB 15383-1994的要求。
3.2 气压
3.2.1 设置气压的调节范围
制造商应给出设置气压的调节范围,该调节范围应包含1999.5Pa(15mmHg),并应与气腹机设置
气压的实际调节范围一致。
3.2.2 气压预置的准确性
气压设置的允差为±266.6Pa(2mmHg)。
3.2.3 气压显示的准确性
气压显示的允差为±266.6Pa(2mmHg)。
3.2.4 过压报警功能
气腹机应具有过压报警功能。
制造商应给出过压报警的报警气压差的标称值,允差±266.6Pa(2mmHg)。
3.2.5 过压释放功能
气腹机应具有过压释放功能。
制造商应给出过压释放时间的标称值,实测值应不大于标称值。

YY 0843-2011
Translated English of Chinese Standard. YY0843‐2011 
YY
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Medical endoscopes - Endoscope supply units -
Insufflators
医用内窥镜 内窥镜功能供给装置 气腹机
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  Requirements ... 4 
4  Test methods ... 6 
5  Inspection rules ... 15 
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 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, Zhang
Qinyuan, and Mao Xinxin.
Medical endoscopes - Endoscope supply units -
Insufflators
1  Scope 
This Standard specifies the requirements and test methods of carbon dioxide insufflators
for medical endoscope.
This Standard applies to the carbon dioxide insufflators that is used in the endoscopic
surgery. The product is used to establish and maintain the pneumoperitoneum in
minimally invasive endoscopic 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
3  Requirements 
3.1 Interface specifications
The suction interface type and connection thread between the insufflator and external air
source shall comply with requirements in GB 15383-1994.
3.2 Air-pressure
3.2.1 Adjustment range of setting air-pressure
The manufacturer shall provide the adjustment range of setting air-pressure. The
adjustment range shall include 1999.5Pa (15mmHg); and it is consistent with the actual
adjustment range of setting air-pressure of insufflators.
3.2.2 Accuracy of the air-pressure presetting
big enough. It shall not generate adverse effect to the ventilation capacity of the system
under test.
4.2.2.1.2 Air-pressure gauge
Its accuracy shall be better than 79.9 Pa (0.6 mmHg). The measurement range shall be
able to cover the actual maximum pressure range when measuring.
4.2.2.1.3 Connecting pipe for measurement
The cross section of ventilation pore that connects to the pipe for measurement shall be
big enough with suitable length. It shall not generate adverse effect to the ventilation
capacity of the system under test.
4.2.2.2 Steps
The insufflators are connected with the air intake unit that comply with the air intake
pressure specified in the attached information.
The insufflators shall be equipped with gas filter and aeroperitoneum pipe during test. The
aeroperitoneum pipe shall be connected with deflated simulation abdominal cavity
through the connection pipes for measurement.
Simulative abdominal cavity shall be connected with the air-pressure gauge through
connecting pipe for measurement.
Control the power supply of the insufflator to maintain it stable at the nominal voltage. This
voltage shall be monitored. The voltage stability shall be controlled within ± 2%.
component shall work normally.
4.2.2.2.2 Measurement procedure
Set the setting air-pressure on the insufflator, expressed as ps. If the setting flow on the
insufflator is adjustable, set its setting flow to the maximum value.
After establishing aeroperitoneum at the simulative abdominal cavity, adjust its gas switch
to a tiny leakage state. In the process of keeping aeroperitoneum, measure the actual
air-pressure pr within the simulative abdominal cavity. The numerical value of pr may be
fluctuant. Record the Pr value when |Pr—Ps| is at miximum.
Adjust the setting air-pressure on the insufflator, so as to make ps take at least 5 values.
1999.5 Pa (15mmHg); the lowest value [if the lowest value ≤666.5 Pa (5mmHg), then the
lowest value of ps shall be 666.5 Pa (5mmHg)]. Measure 3 times at each test point. Take
The result shall indicate the Ps, Pr, Px and Apx values, when Ps is the 5 values set in
4.2.3.2.2 respectively.
4.2.4 Determination of overpressure alarm function
4.2.4.1 Device
Same as 4.2.2.1.
4.2.4.2 Steps
4.2.4.2.1 Preparatory work
4.2.4.2.2 Measurement procedure
Set the setting air-pressure on the insufflators as Psg = 1999.5 Pa (15mmHg). If the setting
flow on the insufflator is adjustable, set its setting flow to the maximum value.
After establishing aeroperitoneum at simulative abdominal cavity, through the auxiliary
methods, gradually increase the air-pressure within the simulative abdominal cavity until
insufflator alarms due to overpressure. Meanwhile, measure the actual air-pressure within
the simulative abdominal cavity, expressed as Prg.
4.2.4.3 Results representation
The alarm air-pressure difference of overpressure alarm is expressed as Prg-Psg.
4.2.5.1 Device
4.2.5.1.1 Simulative abdominal cavity
Same as 4.2.2.1.1.
4.2.5.1.2 Air-pressure gauge
Same as 4.2.2.1.2.
4.2.5.1.3 Connecting pipe for measurement
Same as 4.2.2.1.3.
4.2.5.1.4 Timing device
Accuracy shall be better than 0.01s.
Under-pressure supplementary time is expressed as tq.
Pr1 and tq values shall be indicated in the results.
4.3 Determination of flow
4.3.1 Inspection of adjustment range of setting flow
For operation inspection, adjust the button of setting flow on the insufflator; observe value
display changes of setting flow on the panel of the insufflator, which shall be in consistent
with adjustment range provided by the manufacturer.
4.3.2 Determination of accuracy on the set of flow
4.3.2.1 Device
The accuracy shall be better than 0.5L/min (0.03m3/h). The measurement range shall be
able to cover the actual maximum flow when measuring.
4.3.2.1.2 Connecting pipe for measurement
The cross section of the ventilation pore of the connecting pipe for measurement shall be
large enough with suitable length. It shall not generate adverse effect to the ventilation
capacity of the system under test.
4.3.2.2 Steps
4.3.2.2.1 Preparatory work
The insufflators are connected with the air intake unit that complied with the air intake
The insufflators shall be equipped with gas filter and aeroperitoneum pipe during test. The
aeroperitoneum pipe shall be connected with flow gauge through connecting pipes for
measurement. Control the power supply of the insufflator to maintaint it stable at the
nominal voltage. This voltage shall be monitored. Its stability shall be controlled within ±
2%. After the completion of power-on self-check procedure of insufflators, all parts shall
be in normal operation.
4.3.2.2.2 Measurement procedure
Set the setting air-pressure on the insufflator as Ps = 1999.5 Pa (15mmHg). Set the setting
flow on the insufflator, expressed as Ls.
The filtering rate of filter is given in Formula (1), expressed in %.
where.
n0 - Number of 0.5μm-and-above particles in the air;
n1 - Number of 0.5μm-and-above particles in the air that has flown through the air filter.
4.6 Electrical safety test
The test shall be conducted in accordance with the requirements in GB 9706.1-2007 and
GB 9706.19-2000.
4.7 Endurance test
Under the rated voltage of insufflators, running for 3h and stopping for 1h is deemed as 1
aeroperitnoeum maintaining state; and maintain the aeroperitnoeum in the tiny leakage
state; set the air-pressure and flow to the maximum.
The test shall be conducted in accordance with the provisions in 4.2 and 4.3.
5  Inspection rules 
The inspection rules shall be specified by the manufacturer according to the product
features.
   
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