YY/T 1587-2018 English PDF (YYT1587-2018)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click YY/T 1587-2018
Historical versions: YY/T 1587-2018
Preview True-PDF (Reload/Scroll if blank)

YY/T 1587-2018: Medical endoscopes--Video endoscopes
YY/T 1587-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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 
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
Where:
S - Output signal;
N - The root mean square of the noise signal.
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.
3.7
Sine-based spatial frequency response; s-SFR
The SFR when the target is a sine-wave modulation map.
3.8
Modulation transfer function
The ratio of the maximum signal value minus the minimum signal value to
the maximum signal value plus the minimum signal value.
3.9
Spectral neutral
portion shall be consistent with the internal material. If it is necessary to coat
the surface, the manufacturer shall provide the corresponding coating
requirements and test methods.
4.1.2 Requirements for chemical composition
4.1.2.1 General
The material used in the part in contact with the patient shall be clearly indicated
in any form possible by the manufacturer.
The metal material shall be marked by the designation and/or code as well as
the chemical composition requirements of the material; and be verified by test.
The Chinese and English abbreviations for non-metallic materials shall be
clearly indicated in any possible form.
4.1.2.2 Requirements for dissolved precipitate
The dissolved precipitates of the polymer material in contact with the patient
are as follows:
a) pH: As compared with the same batch of blank control solution, the
difference in pH shall be not more than 2.0;
b) Total content of soluble heavy metals: The total content of soluble heavy
metals in the eluate does not exceed 5.0 μg/mL;
c) Potassium permanganate reducing substance: The difference between
consumption of the same batch of blank control solution of equivalent
volume shall be not more than 2.0 mL.
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.
The biological evaluation may consider the results of biological tests, wherein
the selection of the test items is carried out according to the guidelines of GB/T
16886.1.
For materials that have previously been proven to be applicable, if it can prove
that the subsequent manufacturing process is not sufficient to create a biosafety
hazard, it may not repeat the biological test.
Note 1: If the material of the device under design has an arguable history of use
in a specific application; or otherwise if the information about the
well as the corresponding camera mode (if the video endoscope has multiple
camera modes).
The tolerance of the signal-to-noise ratio is -20%. The upper limit is not counted.
4.6 Spatial frequency response
The manufacturer shall, in the accompanied data, give the nominal value of the
angular frequency of the object space of the video endoscope corresponding to
the SFR value of 50% and 30%, as well as the corresponding camera mode (if
the video endoscope has multiple camera modes).
The tolerance of the angular frequency of the object space corresponding to
the SFR value of 50% and 30% is -20%. The upper limit is not counted.
4.7 Static image tolerance
The manufacturer shall, in the accompanied data, give the nominal value of the
static image tolerance of the video endoscope as well as the corresponding
camera mode (if the video endoscope has multiple camera modes).
The tolerance of the static image tolerance is -20%. The upper limit is not
counted.
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
5.1.2.1 General
Use the method which has an accuracy of better than or reaching to the
tolerance or 1/3 of the limit value to carry out the test of the chemical
When testing on the plane perpendicular to the axis, use the illuminometer to
measure the illuminance at the center of the filed angle. Record it as E0.
Calculate the arithmetic mean of the above four azimuth illuminances E1, E2,
E3, E4, as well as the ratio of the arithmetic mean value to the measured value
of the illuminance at the center of the field angle.
The calculated ratio shall be divided by the relative effect of lambert edge light
luminosity [see formula (2)], where w is the field angle corresponding to the
position where 0.9wp intersects the field angle.
Wp may be replaced by w.
5.4 Test method of brightness response characteristics
Check the technical data as provided by the manufact...