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YY 1081-2011

标准搜索结果: 'YY 1081-2011'
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YY 1081-2011 英文版 1100 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 冷光源 有效

   
标准详细信息 YY 1081-2011; YY1081-2011
中文名称: 医用内窥镜 内窥镜功能供给装置 冷光源
英文名称: Medical endoscopes - Endoscope supply units - Cold light sources
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
旧标准 (被替代): YY 91081-1999
引用标准: GB/T 5702-2003; GB/T 7922-2008; 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、杭州好克光电仪器有限公司
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: 本标准规定了对冷光源的要求。本标准适用于内窥镜检查和手术中作为功能供给装置的冷光源, 其他冷光源可根据适用性来选择采用。

YY 1081-2011
Medical endoscopes - Endoscope supply units - Cold light sources
ICS 11.040.99
C40
中华人民共和国医药行业标准
代替YY91081-1999
医用内窥镜
内窥镜功能供给装置 冷光源
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。
本标准实施之日起YY91081-1999《医用内窥镜 冷光源》废除。
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、杭州好克光电仪器有限公司。
本标准主要起草人:贾晓航、颜青来、章渭兴、何涛、齐伟明、陈盛来。
本标准所代替标准的历次版本发布情况为:
---YY91081-1999。
医用内窥镜
内窥镜功能供给装置 冷光源
1 范围
本标准规定了对冷光源的要求。
本标准适用于内窥镜检查和手术中作为功能供给装置的冷光源,其他冷光源可根据适用性来选择
采用。
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/T 5702-2003 光源显色性评价方法
GB/T 7922-2008 照明光源颜色的测量方法
GB 9706.1-2007 医用电气设备 第1部分:安全通用要求
GB 9706.19-2000 医用电气设备 第2部分:内窥镜设备安全专用要求
3 术语和定义
下列术语和定义适用于本文件。
3.1
光缆入光面 lightinputsurfaceoftheopticalfibercable
光缆与冷光源的连接端的有效通光表面。
3.2
参考面 referenceplane
冷光源连接适配光缆后与光缆入光面重合的平面。
3.3
参考窗口 referencearea
位于参考面上,以适配光缆的入光面圆心为中心、直径D=5mm的圆形窗口。
4 要求
4.1 构成
制造商应以任何可行的形式给出冷光源的构成,包括所适用灯泡的特征,并明确该构成中是否含有
导光束。
制造商所提供的产品应与其描述的构成相符。
4.2 光谱性能
4.2.1 显色指数
除特殊光谱用途外,适用于光学观察镜的冷光源,应具有良好的显色性,显色指数应不小于90。

YY 1081-2011
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing YY 91081-1999
Medical endoscopes -
Endoscope supply units -
Cold light sources
医用内窥镜
内窥镜功能供给装置 冷光源
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 01, 2013
Issued by. The State Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements ... 5
5 Test Methods ... 7
6 Inspection Rules ... 13
Appendix A ... 14
Foreword
This Standard was drafted in accordance with provisions given in GB/T 1.1-2009.
From the date of implementation of this Standard, YY 91081-1999 "Medical endoscope -
Cold light source" shall be abolished.
Please note that some of the contents in this document may involve patents. The
organization that issued this document does not assume responsibility for the identification
of these patents.
This Standard was proposed by the State Food and Drug Administration.
This Standard shall be administered by the National Optical and Medical Instruments
Standardization Technical Committee (SAC/TC 103/SC 1).
Drafting organizations of this Standard. State Food and Drug Administration, Hangzhou
Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Device Control
Institute, and Hangzhou Haoke Photoelectric Instrument Co., Ltd.
Main drafters of this Standard. Jia Xiaohang, Yan Laiqing, Zhang Weixing, He Tao, Qi
Weiming, and Chen Shenglai.
The previous standard replaced by this Standard is.
- YY 91081-1999.
Medical endoscopes -
Endoscope supply units -
Cold light sources
1 Scope
This Standard specifies the requirements for cold light sources.
This Standard applies to cold light sources which are used as a function of supply device in
endoscope inspection and surgery, other cold light sources can selectively adopt this
document according to the applicability.
2 Normative References
For the application of this document, the following documents are essential. For dated
references, only the dated editions are applicable to this document. For undated references,
the latest editions (including any amendments) apply to this document.
GB/T 5702-2003 Light source color rendering evaluation method
GB/T 7922-2008 Color of light source measurement methods
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 Terms and Definitions
The following terms and definitions apply in this document.
3.1 Light input surface of the optical fiber cable
Effective light-through surface at the connection terminal between the optical fiber cable and
the cold light source.
3.2 Reference plane
The coincide plane between the light input surface of the optical fiber cable and the cold light
source which is connected with adaptation cable.
The central axis of single fiber shall be perpendicular to the terminal surface of the single fiber.
Measurement of known light energy transfer efficiency k and light energy transfer efficiency k
shall be performed in accordance with Appendix A.
5.8.1.2 Positioning device
It shall be able to position the light input surface of standard single fiber for measurement, to
to let the center of light input surface to coincide with the center of reference window of cold
light source; and center axis to be perpendicular to the plane of reference window.
5.8.1.3 Photometer or equivalent device
Difference of measurement repeatability shall not be greater than 1%; accuracy level shall be
similar to Grade 2 illuminometer which complies with provisions of JB/T 7403 1994; it is used
to measure the luminous flux emitted from the light output surface of the standard single fiber.
5.8.2 Steps
5.8.2.1 Preparations
CONTROL the test environment, the dark intensity shall not be more than 1 lx.
voltage shall be monitored, the voltage stability shall be controlled within ± 2%.
Light source shall be fully preheated, time shall not be less than 30 min.
The intensity setting of cold light source shall be adjusted to the maximum.
5.8.2.2 Measurement of luminous flux
USE positioning device to position the light input surface of standard single fiber onto the
reference window of cold light source, and LET the center of light input surface to coincide
with the center of reference window of cold light source; and center axis to be perpendicular
to the plane of reference window.
MEASURE the luminous flux emitted from the light output surface of standard single fiber,
and Φt, that is the total output luminous flux.
5.9 Electrical safety performance test
It shall be conducted in accordance with the specified methods in GB 9706.1-2007 and GB
9706.19-2000.
5.10 Mechanical interface specifications
USE naked-eyes, operating and general gages to measure.
5.11 Inspection of safety measures of structure and anti-faults
It shall be checked to verify if it is compliant with requirements of 4.1 and 4.7.
6 Inspection Rules
A.2 Environmental conditions
Test environment shall be controlled within dark intensity no more than 1 lx.
A.3 Steps
As shown in Figure A.1, USE clamp to fix and adjust the laser source and the photometer,
LET the laser spot to fully and perpendicularly incident into photometer, MEASURE the
luminous flux, denoted as Φ i.
As shown in Figure A.2, USE clamp to fix and adjust the laser source and the photometer,
LET the laser spot to fully and perpendicularly incident at the center position of light input
surface of single fiber, MEASURE the luminous flux emitted from the light output surface of
The light energy transfer efficiency k of standard single fiber for measurement shall be
determined by formula (A.1).
   
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