YY 1081-2011 (YY1081-2011) & related versions
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Medical endoscopes - Endoscope supply units - Cold light sources
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YY 1081-2011
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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
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
ensure the light input surface to be located on the reference window of cold light source, and
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.
CONTROL the power supply of light source to remain stable at the nominal voltage, the
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,
then it is divided by light energy transfer efficiency k of standard single fiber for measurement
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
Inspection rules shall be based on product features and decided by manufacturer.
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
single fiber, denoted as Φ0.
The light energy transfer efficiency k of standard single fiber for measurement shall be
determined by formula (A.1).
......
| Standard ID | YY 1081-2011 (YY1081-2011) | | Description (Translated English) | Medical endoscopes - Endoscope supply units - Cold light sources | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 12,115 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY 91081-1999 | | Quoted Standard | GB/T 5702-2003; GB/T 7922-2008; GB 9706.1-2007; GB 9706.19-2000 | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the requirements for cold light. This standard applies to endoscopy and surgery as a function of the cold light supply device, the other cold light source can be selected according to the applicability of adoption. |
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