YY/T 1028-2023 English PDF (YYT1028-2023)

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YY/T 1028-2023: Medical endoscopes - Fiber endoscopes
YY/T 1028-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
Medical Endoscopes - Fiber Endoscopes
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).
4.4 Depth of Field of Observation
If the manufacturer claims that the fiber endoscope has a depth of field effect, then, the depth
of field range of observation shall be provided in the accompanying documents. Otherwise, it
shall be stated in the accompanying documents that there is no depth of field effect.
Within the nominal depth of field range of the fiber endoscopes, the angular resolution at the
center of the field of view shall be not lower than 80% of the measured value of the angular
resolution at the center of the field of view at the designed optical working distance d0.
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.
The illumination at 90% field of view of Wp shall be uniform. On this field of view zone, select
4 orthogonal azimuths for testing, and their uniformity (i.e., non-uniformity) shall satisfy the
requirements of Table 1.
and comfortable.
4.8 Number of Broken Filaments in the Fiber Imaging Bundle
The number of broken filaments within 50% of the field of view diameter range shall not be
more than 3, and the broken filaments shall not be adjacent; the number of broken filaments
beyond 50% of the field of view diameter range shall not be more than 10, and there shall not
be 3 or more adjacent broken filaments, and the number of adjacent broken filaments shall not
be more than 2.
4.9 Number of Misaligned Filaments in the Fiber Imaging Bundle
The number of misaligned filaments within 50% of the field of view diameter range shall not
be more than 3, and the misaligned filaments shall not be adjacent; the number of misaligned
filaments beyond 50% of the field of view diameter range shall not be more than 10, and there
shall not be 3 or more adjacent misaligned filaments, and the number of adjacent misaligned
filaments shall not be more than 2.
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
4.10.2.1 Outer surface quality
It shall comply with the following requirements.
a) The bonding of each connecting piece shall be firm and reliable, and the welded parts
shall be smoothly welded, without any insufficient solder, desoldering or overlaying.
b) The outer surfaces of the head end, insertion part, operating hand wheel and eyepiece
adjustment ring shall be flat and smooth, without obvious bulges or scratches, burrs
and other defects.
4.10.2.2 Water supply and air supply system
It shall comply with the following requirements.
a) The water supply and air supply shall be smooth. When water is supplied, it shall be
able to flush the surface of the objective lens window, and the water supply volume
and air supply volume shall not be less than the limit values specified by the
manufacturer.
b) The water supply and air supply buttons shall be able to be freely tilted, without any
clamping stagnation.
c) The joints of the water supply and air supply system shall be properly coordinated
and well-sealed, and there shall be no water or air leakage.
4.10.2.3 Suction and instrument channel system
It shall comply with the following requirements.
a) The suction shall be smooth, and there shall be a blowout prevention device for liquids
in the human body cavity at the insertion opening of the pliers. During liquid suction
operation, there shall be no back-spray of liquids at the blowout prevention device
and suction button.
b) The suction volume shall not be less than the limit value specified by the manufacturer.
c) The suction button shall be able to be freely tilted, without any clamping stagnation.
4.10.2.4 Angle control system
It shall comply with the following requirements.
a) When operating, the angle hand wheel shall be light and flexible, without any
tightness, looseness or stagnation.
b) The angle locking mechanism shall be able to lock the hand wheel. After unlocking
the fixed bending angle, it shall not affect the operating function of the angle hand
wheel.
c) The limit deviation of the angle size is 10% (the upper limit is not included).
4.10.2.5 Sealing performance
It shall comply with the following requirements.
a) Put the fiber endoscope into the water as a whole, and its inner cavity can withstand
a pressure of 30 kPa for 3 minutes without air leakage (applicable to waterproof type).
b) The fiber endoscope is used within the range of 10 C ~ 4...