YY 1081-2011 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 1081-2011 | English | 145 |
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Medical endoscopes - Endoscope supply units - Cold light sources
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YY 1081-2011: Medical endoscopes - Endoscope supply units - Cold light sources---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY1081-2011
ICS 11.040.99
C 40
INDUSTRY STANDARD
Replacing YY 91081-1999
Medical endoscopes -
Endoscope supply units -
Cold light sources
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.
4 Requirements
4.1 Structure
The manufacturer shall provide the structure of cold light source in any viable form, including
the characteristics of applicable bulb. And it shall clearly indicate if there is guided optical
beam contained in the structure.
The product provided by manufacturer shall be consistent with the described structure.
4.2 Spectral properties
spectrums, it shall provide the distribution and matching ratio of the corresponding spectrums.
4.2.4 Spectral characteristics of cold light source of special spectrum use
For cold light source of special spectrum use, the manufacturer shall provide the spectral
characteristics of cold light source, including the spectrum’s main peak value, the nominal
value and tolerance of FWHM (full width at half maximum). Cold light source shall comply
with the spectral characteristics.
4.3 Illumination uniform performance of reference window
4.3.1 Illumination uniformity
The manufacturer shall provide the nominal value of illumination uniformity of reference
window for cold light source used for rigid endoscope. the actual measured value shall not be
greater than 1.05 times of the nominal value.
4.4 Radiation performance
4.4.1 Total output luminous flux
The manufacturer shall provide the nominal value of the total output luminous flux, tolerance
of -10%, the upper limit does not count.
4.5 Electrical Safety
4.7 Safety measures of anti-fault
For cold light source used for surgery, it shall have safe measures of anti-fault, it may adopt
methods such as providing indication of life-span of bulbs or providing indication of changing
bulbs, or the use of spare bulbs.
5 Test Methods
5.1 Determination of CRI
5.1.1 Device
Spectroradiometer system. Spectral measurement range shall not be less than 380 nm - 780
nm, the wavelength resolution shall not be greater than 1.5.nm, the relative spectral radiance
difference shall not be greater than 1%.
5.1.3 Calculation
It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922-2008.
5.2 Calculation of correlated color temperature
The relative spectral power distribution S(λ) of cold light source is obtained according to the
measurement of 5.1.2, CALCULATE color coordinates u, v according to GB/T 5702-2003,
Then FIND the corresponding correlated color temperature according to blackbody radiation
locus in uv chromaticity coordinates graph.
5.3 Calculation of radiation flux ratio of red, green and blue light
According to the correlated spectral power distribution S(λ) of cold light source obtained from
the measurement of 5.1.2, Φer, Φeg, Φeb shall be determined by formula (1), (2), (3)
respectively.
5.5 Calculation of infra-red cutoff performance
5.1.2 The relative spectral power distribution S(λ) of cold light source is obtained according
to the measurement of 5.1.2, CALCULATE the ration of output radiation flux and luminous
flux according to photometry principle.
5.6 Determination of illumination uniformity
5.6.1 Device
5.6.1.2 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
it can meet the positioning requirements of measurement positions selected on reference
window.
5.6.2 Steps
5.6.2.1 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.
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.
6 Inspection Rules
Inspection rules shall be based on product features and decided by manufacturer.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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