YY/T 1587-2018 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1587-2018 | English | 145 |
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Medical endoscopes - Video endoscopes
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YY/T 1587-2018: Medical endoscopes - Video endoscopes---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/YYT1587-2018
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.99
C 40
Medical endoscopes - Video endoscopes
Issued on. JUNE 26, 2018
Implemented on. JULY 01, 2019
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 8
5 Test methods... 11
Appendix A (Normative) Test method of brightness response characteristics 14
Appendix B (Normative) Test method of signal-to-noise ratio... 19
Appendix C (Normative) Test method of spatial frequency response... 23
Appendix D (Normative) Test method of static image tolerance... 29
Foreword
This standard was drafted according to the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents.
The issuing organization of this document is not responsible for identifying
these patents.
This standard was proposed by the State Drug Administration.
This standard shall be under the jurisdiction of the National Technical
Committee for Standardization of Medical Optics and Instruments (SAC/TC
103/SC 1).
Drafting organization of this standard. Zhejiang Medical Device Inspection
Institute.
The main drafters of this standard. Yan Qinglai, Jia Xiaohang, Zhang Qinyuan,
Shen Huanbo, Luo Yongjie, Xu Zhangheng, He Tao, Zheng Jian.
Medical endoscopes - Video endoscopes
1 Scope
This standard specifies the terms and definitions, requirements, test methods
for medical video endoscopes.
This standard applies to medical video endoscopes (hereinafter referred to as
video endoscopes) for visible spectrum imaging in endoscopy and surgery.
This standard does not apply to medical video endoscopes for special spectral
and non-visible spectral imaging.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB 9706.19 Medical electrical equipment - Part 2.Particular requirements
for the safety of endoscopic equipment
GB/T 14233.1-2008 Test methods for infusion transfusion injection
equipment for medical use - Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1.Evaluation
and testing
YY 0068.1-2008 Medical endoscopes - Rigid endoscope - Part 1.Optical
properties and test methods
YY 0068.2 Medical endoscopes - Rigid endoscope - Part 2.Mechanical
properties and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Conversion function
The conversion relationship between different variables.
3.2
Noise
The disturbance as generated inside the response signal of the video
endoscope.
3.3
Signal-to-noise ratio
At a particular signal level, the ratio of the output signal to the root mean
square value (rms) of the noise signal, which is represented by a logarithmic
value. The representation is as shown in formula (1).
3.4
Saturation value
The output signal value which further increases the brightness of the object
while the output signal remains constant.
3.5
Static image tolerance
The ratio of the maximum brightness of the critical object plane to the
minimum brightness of the critical object plane that the video endoscope can
distinguish in a single exposure.
3.6
Spatial frequency response; SFR
In a video endoscope, the function relationship between the ratio of the
modulation of the output signal which is subjected to the calculated value of
the reverse function of OECF to the modulation of the brightness of the
object plane of the target, and the spatial frequency of the target.
4 Requirements
4.1 Materials used in contact with the patient
4.1.1 Metal surface material
If the material used in contact with the patient is a metallic material, the exposed
w or wp
4.1.2 Requirements for chemical composition
4.1.3 Biocompatibility
Materials in contact with patients shall be evaluated for biosafety according to
the principles and requirements of GB/T 16886.1, to demonstrate good
biocompatibility.
4.2 Field angle
It shall meet the requirements of the field angle in 4.2.1 of YY 0068.1-2008.
4.3 Reflective self-effect of illumination light luminosity
The manufacturer shall give the nominal value of the reflective self-effect of
illumination light luminosity ILeR at the 90% field angle of the wp as given in the
accompanied documentation. The measured value of the reflective self-effect
of illumination light luminosity shall be not less than the nominal value.
The manufacturer shall, in the technical data, give the nominal value of the
signal-to-noise ratio of the temporally varying noise of the video endoscope, as
well as the corresponding camera mode (if the video endoscope has multiple
camera modes).
4.8 Mechanical properties
The mechanical properties of rigid video endoscopes shall comply with the
requirements of YY 0068.2.
4.9 Electrical safety
It shall meet the requirements of GB 9706.19.
5 Test methods
5.1 Test of material requirements
5.1.1 Surface material
Visual inspection. For products with a surface coating, follow the appropriate
test methods as provided by the manufacturer.
5.1.2 Test of chemical composition
5.1.3 Biocompatibility
All tests are preferred to use the relevant standards as described in GB/T
16886.1 and are carried out according to their methods.
5.2 Test of field angle
It shall be carried out according to the method of measuring the field angle as
specified in 5.1 of YY 0068.1-2008.
5.3 Test of relative self-effect of illumination light luminosity
The video endoscope is connected to a light source as provided by the
manufacturer.
5.5 Test method of signal-to-noise ratio
Check the technical data as provided by the manufacturer.
Use the method as specified in Appendix B to measure the signal-to-noise ratio
of the video endoscope.
5.6 Test method of spatial frequency response
Check the contents of the accompanied data as provided by the manufacturer.
Use the method as specified in Appendix C to measure the spatial frequency
response of the video endoscope.
5.7 Test method of static image tolerance
Check the contents of the accompanied data as provided by the manufacturer.
Use the method as specified in Appendix D to measure the static image
tolerance of the video endoscope.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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