YY/T 1028-2023 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1028-2023 | English | 245 |
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Medical endoscopes - Fiber endoscopes
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| YY 1028-2008 | English | 105 |
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Upper gastro intestinal fiberscope
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YY/T 1028-2023: Medical endoscopes - Fiber 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/YYT1028-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040
CCS C 40
Replacing YY/T 1028-2008, YY/T 0283-2007
Medical Endoscopes - Fiber Endoscopes
Issued on. SEPTEMBER 5, 2023
Implemented on. SEPTEMBER 15, 2024
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 5
4 Requirements... 6
5 Test Methods... 11
1 Scope
This document specifies the requirements for medical fiber endoscopes and describes the
corresponding test methods.
This document is applicable to medical fiber endoscopes.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
JJG 245-2005 Verification Regulation of Illuminance Meter
YY 0068.1-2008 Medical Endoscopes - Rigid Endoscope - Part 1.Optical Properties and Test
Methods
YY/T 0068.2 Medical Endoscopes - Rigid Endoscope - Part 2.Mechanical Properties and Test
Methods
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 fiber endoscope
An endoscope usually consists of an objective lens system and an optical imaging / transferring
system (including fiber imaging bundle), with or without an observation eyepiece system, to
form an observation light path.
3.2 max vertex field angle
The opening angle of the center of the fiber endoscope end to the height of the maximum field
of view on the object side.
3.3 max object pupil field angle
Wp
The opening angle of the fiber endoscope imaging system��s entrance pupil center to the height
of the maximum field of view on the object side.
3.4 working distance
The distance between the object being observed and the fiber endoscope end.
4 Requirements
4.1 General Requirements
The optical system shall be able to ensure clear observation, and there shall be no degumming,
demolding or cracks in the adhesive. The optical elements shall not have pitting, scratches,
bubbles, oil spots, mold spots, dust and other attachments that may affect the observation.
4.2 Field Angle
The manufacturer shall provide the design value of the endoscope field angle in the
accompanying documents, with an allowable error of 15%.
4.3 Angular Resolution
The manufacturer shall provide the nominal value of the angular resolution at the center of the
field of view at the design optical working distance d0 in the accompanying documents, and the
allowable error of the nominal value is 10% (the upper limit is not included).
4.5 Illumination Edge Uniformity
When inspecting within the depth of field range of observation, the illumination spot shall fill
the effective scale of the field of view.
4.6 Light Energy Transfer Efficiency---Effective Photometric Rate
The light energy transfer efficiency of a fiber endoscope is expressed in terms of effective
photometric rate. For fiber endoscopes, the effective photometric rate is expressed in the symbol
DM, which is defined as the ratio of the average luminous exitance of the object surface to the
average illumination of the fundus image surface. For non-visual fiber endoscopes, this
effective photometric rate is defined as the lowest object surface luminance (Lmin), at which, the
image surface displays a critical discernible gray scale.
4.10 Mechanical Properties
4.10.1 Mechanical properties of rigid fiber endoscopes
They shall comply with the requirements of YY/T 0068.2.
4.10.2 Mechanical properties of flexible fiber endoscopes
4.10.2.8 Dimensional deviation
It shall comply with the following requirements.
5 Test Methods
5.1 General Requirements
Place a uniform white background on the end under test, observe the optical system through the
eyepiece, and determine whether it complies with the stipulations of 4.1.
5.2 Field Angle
Carry out the test in accordance with the field angle determination method specified in 5.1 of
YY 0068.1-2008.
5.3 Angular Resolution
5.3.1 Equipment
5.3.1.1 Resolution standard board, each group of line pairs has at least two directions, such as.
horizontal direction and vertical direction, and the range is 1 lp/mm ~ 100 lp/mm.
5.3.2 Steps
5.3.2.1 Place the fiber endoscope on the optical bench.
5.3.2.2 Place the resolution standard board at the designed optical working distance d0 of the
fiber endoscope and fix it vertically to the visual axis.
5.3.2.8 Install the fiber endoscope in the endoscope fixture, and the visual axis is aligned with
the measurement mark.
5.3.2.9 By observing the ring of the measurement mark, adjust the fixture of the fiber endoscope,
so that the small ring of the measurement mark coincides with the field of view and
perpendicular to the visual axis.
5.3.2.10 Respectively mark the position of the end apex of the fiber endoscope and the central
vertical line of the measurement mark ring and use a length measuring tool to measure and
record the distance between them as d1 (mm).
5.3.2.11 In the direction of the visual axis, move the fiber endoscope or measurement mark, so
that the large ring of the measurement mark coincides with the field of view and perpendicular
to the visual axis.
5.3.3 Calculation
In accordance with Formula (2), calculate the distance a between the entrance pupil and the
vertex.
5.4 Depth of Field of Observation
Fix the fiber endoscope and adjust the distance between the head end surface and the object
being observed. At the two positions of the closest end and the farthest end of the nominal depth
of field range, in accordance with the test method in 5.3, respectively test the angular resolution
at the center of the field of view at the corresponding position. Determine whether it complies
with the stipulations of 4.4.
5.5 Illumination Edge Uniformity
In accordance with the method of 5.1 in YY 0068.1-2008, measure Wp.
Use the test light source to illuminate an integrating sphere. The illumination light entrance of
the fiber endoscope is pasted with cosine transmission material, and then, enters the small hole
of the integrating sphere. The diameter of the small hole is not greater than 10% of the diameter
of the integrating sphere.
5.6 Light Energy Transfer Efficiency---Effective Photometric Rate
5.6.1 Equipment
5.6.1.1 Bracket and platform, which are used for supporting the fiber endoscopes.
5.6.1.2 Cosine radiation screen. An illumination source with adjustable light intensity is
enclosed on the back of the screen, and its spectral characteristics shall be compatible with the
intended application of the fiber endoscope under test. The brightness of the screen is consistent,
and the unevenness is not greater than 5%. Except the screen surface, this radiation screen has
no other light leakage.
5.6.2 Environmental conditions
5.6.2.1 The test environment is controlled so that the dark illumination is not greater than 1 lx.
5.6.3 Steps
5.7 Diopter Regulation
At the designed optical working distance d0 of the fiber endoscope, place a cross (or grid) reticle
as the object to be measured. Aim the dioptometer at the end face of the eyepiece with adjustable
diopter, adjust the diopter scale of the eyepiece to the maximum emmetropia value, then, when
the dioptometer focuses on the object being measured and the image is clear, read the diopter
value of the dioptometer, adjust the eyepiece diopter scale value to the maximum negative
diopter value, read the diopter scale value in the same way, and determine whether it complies
with the stipulations of 4.7.
5.8 Number of Broken Filaments in the Fiber Imaging Bundle
Place a uniform white background on the end under test, observe the broken filaments in the
imaging bundle through the eyepiece, and determine whether it complies with the stipulations
of 4.8.
5.9 Number of Misaligned Filaments in the Fiber Imaging Bundle
Place a four-quadrant color (red, blue, green and yellow) background at the end under test,
observe the misaligned filaments in the imaging bundle through the eyepiece, eliminate the
influence of the position of broken filaments in 5.8, and determine whether it complies with the
stipulations of 4.9.
5.10 Mechanical Properties
5.10.1 Mechanical properties of rigid fiber endoscopes
Carry out the test in accordance with the test method specified in YY/T 0068.2 and determine
whether it complies with the stipulations of 4.10.1.
5.10.2 Mechanical properties of flexible fiber endoscopes
5.10.2.1 Outer surface quality
Verify through visual observation and hand feel inspection and determine whether it complies
with the stipulations of 4.10.2.1.
5.10.2.2 Water supply and air supply system
The water supply and air supply performance test shall be conducted as follows.
5.10.2.3 Suction and instrument channel system
The suction test shall be carried out as follows.
5.10.2.4 Angle control system
Imitate the method of use to operate the angle hand wheel and locking hand wheel to
respectively bend and lock the angle part in the upward, downward, left and right directions.
a) Determine whether it complies with the stipulations of 4.10.2.4 a) based on the angle
hand wheel controllability;
5.10.2.5 Sealing performance
In accordance with the following steps, carry out the test.
a) Connect the leakage detection device attached to the product to the ventilation valve
of the light guide plug part of the fiber endoscope. Press the airbag on the pressure
leakage detection device, and when the barometer��s indication rises to 22 kPa, place
the endoscope body in water, until the water is deep enough to immerse the endoscope
body. Turn the angle hand wheel to bend in the upper and lower directions, and bend
in each direction for3 times. Within 3 minutes after stabilization, there shall be no
bubbles emerging from the endoscope body. It shall comply with the requirements of
4.10.2.5 a).
4.10.2.5 b).
5.10.2.6 Matching with accessories
Insert the supplied surgical instruments into the instrument channel and extend them from the
outlet of the instrument channel at the tip. The surgical instruments shall be within the field of
view of the fiber endoscope, and freely move without clamping stagnation. Determine whether
it complies with the stipulations of 4.10.2.6 a) and b).
5.10.2.7 Marks
In accordance with the following steps, carry out the test.
5.10.2.8 Dimensional deviation
Use a general measuring tool or special-purpose measuring tool to conduct the measurement,
and determine whether it complies with the stipulations of 4.10.2.8.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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