GB 11244-2005 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 11244-2005 | English | 105 |
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General requirements for the medical endoscope and endoscope accessories
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| GB 11244-1989 | English | 359 |
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General specifications for medical fiber endoscope
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GB 11244-2005: General requirements for the medical endoscope and endoscope accessories---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/GB11244-2005
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.55
C 40
Replacing GB 11244-1989
General requirements for the medical endoscope and
endoscope accessories
Issued on. JULY 21, 2005
Implemented on. DECEMBER 01, 2005
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the PRC;
Standardization Administration of the PRC.
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 8
5 Type inspection... 10
6 Inspection rules... 17
7 Marking... 18
8 Instructions for use... 18
9 Packaging, transportation and storage... 20
Foreword
This Standard is developed in accordance with the international standard ISO
8600.1997 "Medical endoscopes and endoscopic accessories". In terms of
technical content, it is not equivalent to ISO 8600.1997.
Used in conjunction with this Standard is GB 9706.19-2000 "Medical electrical
equipment - Part 2.Particular requirements for the safety of endoscopic
equipment". The main technical differences between this Standard and ISO
8600 are as follows.
- Incorporate all the inspection methods of ISO 8600-3 and ISO 8600-4 and
the inspection provisions of ISO 8600-1 into this Standard.
- According to the actual situation of China, the environmental test adopts
the relevant regulations of GB/T 14710.
- ADD the requirement of coincidence of lighting source and observation field
of view.
- The shape and size of the eyepiece are identical to the requirements of
DIN58105 "Requirements and inspection of medical endoscopes".
- ADD the requirements for inspection rules, packaging, transportation and
storage.
[Translator note. The original text is reformatted to items, for ease of reading]
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical
Subcommittee on Medical Optics and Instruments of Standardization
Administration of China.
Drafting organization of this Standard. Shanghai Medical Optical Instrument Co.,
Ltd.
Main drafters of this Standard. Mai Xiuqin, Li Yafen, Xue Xiaoguo, Qian
Xiaoyang.
General requirements for the medical endoscope and
endoscope accessories
1 Scope
This Standard gives the terminology, general technical requirements, general
test methods, inspection rules, marking, instructions for use, packaging,
transportation and storage of endoscope and endoscope accessories used in
medical clinics. The particular technical requirements for various types of
endoscopes shall meet the requirements of the corresponding particular
standards.
2 Normative references
The following documents contain provisions which, through reference in this
Standard, constitute provisions of this Standard. For the dated references, their
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest editions of these
documents are applicable. For undated reference documents, the latest
editions apply to this Standard.
GB/T 191-2000 Packaging - Pictorial marking for handling of goods
GB 9706.19-2000 Medical electrical equipment - Part 2.Particular
requirements for the safety of endoscopic equipment (idt IEC 60601-2-
18.1996)
3 Terms and definitions
The following terms and definitions apply to this Standard.
3.1
Endoscope
Medical instruments for observation purposes, with or without lenses; medical
devices which go deep into the natural or surgically opened pores of the human
body for examination, diagnosis or treatment.
3.2
Endoscope accessory
Medical devices which can penetrate the endoscope into the natural or
surgically opened pores of the human body; or medical devices which can be
used for inspection, treatment, or diagnosis with an endoscope.
3.3
Rigid endoscope
The endoscope (endoscope accessory) of which the insertion portion cannot
be bent into the human body's natural or surgically opened pore or instrument
channel.
3.4
Flexible endoscope
The endoscope (endoscope accessory) of which the insertion portion can freely
bend into the human body's natural or surgically opened pore or instrument
channel.
3.5
French; Fr
The measurement method for the size of the endoscope with circular or non-
circular cross-section, which is defined as.
4 Requirements
4.1 Surface and edge
4.2 Maximum insertion portion width
The maximum insertion portion width must not be larger than the size specified
in the instructions for use provided by the manufacturer. See 8.2 c).
4.3 Minimum insertion channel width
The minimum insertion channel width must not be less than the size specified
in the instructions for use provided by the manufacturer. See 8.2 h).
4.4 Field of view
If the manufacturer has no other special regulations, the deviation of the field of
view of optical endoscope from the nominal value provided by the manufacturer
shall not exceed 15%. In the product catalog and manual materials, the
description of the field of view is not mandatory.
4.7 Coincidence of lighting source and observation field of view
At the working distance, the illumination spot shall fill the field of view, without
obvious dividing line between bright and dark.
4.8 Safety
Endoscopes and endoscope accessories shall meet the requirements of GB
9706.1.
4.9 Biocompatibility
The outer surface material of the insertion portion is an external access device,
which is in short-term contact with the tissue. Its biocompatibility shall be
evaluated according to the requirements of GB/T 16886.1-2001.
5 Type inspection
5.1 Surface and edge
Under sufficient lighting, use visual inspection and hand feel inspection. It shall
meet the requirements of 4.1, without the need for magnifying tools.
5.2 Maximum insertion portion width
5.2.1 Scope
This section gives the measurement method for the maximum insertion portion
width of medical endoscopes and endoscope accessories. It can be expressed
in millimeters or French (millimeters).
5.2.3 Accuracy of measuring instrument
An instrument with an accuracy of 0.05 mm (such as vernier calipers) shall be
used for measurement. If the French size of the perimeter is measured, an
instrument with an accuracy of 0.5 mm (such as a tape measure or similar
measuring tool) shall be used.
5.2.4 Measurement process
5.2.4.1 Readings in millimeters
For the measurement of readings in millimeters, it shall measure the maximum
diameter of the circumscribed circle perpendicular to the axis of the insertion
portion [see Figure 4a) and b)]. This maximum diameter is defined as the
maximum diameter measured on all cross-sections perpendicular to the axis
along the entire length of the insertion portion.
5.2.4.2 Readings in French size
For readings expressed in French size, it shall measure the maximum perimeter
of the cross-section perpendicular to the axis of the insertion portion. The
maximum perimeter is defined as the longest perimeter measured across all
cross-sections perpendicular to the axis along the entire length of the insertion
portion.
5.3 Minimum insertion channel width
The accuracy of the measuring instrument for measuring the minimum insertion
channel width shall not be greater than 0.01 mm.
5.4 Field of view and direction of view
5.4.3.4 Illumination
White light shall be used to illuminate the measuring mark. The minimum
illumination is not less than 500 lx. Endoscope or external light source can be
used.
5.4.4 Test method for field of view and direction of view
The following test method is for recommendation only. If the same results can
be obtained, other methods can also be used.
5.5 Funnel-shaped eyepiece cover
USE a length measuring instrument with an accuracy of ±5% and a goniometer
with an accuracy of ±5%.
5.6 Coincidence of lighting source and observation field of view
When the matching light source is in the brightest state, use visual inspection.
It shall meet the requirements of 4.7.
6 Inspection rules
6.1 General
Endoscopes and endoscope accessories shall pass the inspection by the
manufacturer’s quality test department; be accompanied by a product quality
inspection conformity certificate, before leaving the factory.
6.3 Inspection classification and inspection items
6.3.1 Inspection is classified into exit-factory inspection and type inspection.
6.4 Determination rule and reinspection rule
6.4.1 The exit-factory inspection is a full inspection. If any of the inspection
items is not met, the product is not qualified.
6.4.2 Type inspection randomly selects 2 sets from the products, which have
passed the exit-factory inspection.
7 Marking
7.1 Least marking
Each endoscope and endoscope accessory shall have the following markings.
7.2 Clear marking
After the equipment is used, cleaned, disinfected, sterilized and stored in
accordance with the manufacturer's instructions for use, the markings must be
kept clear.
7.3 Exceptional marking
When it is impossible to mark on the separable part or the installation parts of
the separable part of the equipment due to the size or shape, the required mark
shall be partly marked on the package or partly on the instructions for use.
8 Instructions for use
8.1 The manufacturers of endoscopes and endoscope accessories provide
users with instructions for use, which shall include at least the following.
8.2 The identification and specifications of the equipment shall include the
following.
8.3 The prevention and application instructions when using the equipment shall
include.
9 Packaging, transportation and storage
9.1 There shall be the following markings on the outer packaging box.
9.2 Each set of medical endoscopes and endoscope accessories shall be
accompanied by a product manual, inspection conformity certificate and
packing list; packaged in moisture-proof paper bags or plastic bags, and placed
in the box.
9.3 Medical endoscopes and endoscope accessories are first packed in a dry
shock-proof and moisture-proof box; and then packed into a shock-proof and
moisture-proof outer packaging box.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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