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GB 11244-2005 English PDF (GB11244-2005)

GB 11244-2005 English PDF (GB11244-2005)

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GB 11244-2005: General requirements for the medical endoscope and endoscope accessories

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.
GB 11244-2005
GB
NATIONAL STANDARD OF THE
PEOPLE 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
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)
GB/T 14710-1993 The environmental requirements and test methods for
medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1:
Evaluation and testing (idt ISO 10993-1:1997)
3 Terms and definitions
The following terms and definitions apply to this Standard.
3.1
Endoscope
Where:
?? - The perimeter of the section, in millimeters (mm).
3.6
Distal
The position of the endoscope accessories of all endoscopes is farther from the user than other reference points.
3.7
Proximal
The positions of all endoscopes and endoscope accessories are closer to the user than other reference points.
3.8
Instrument channel
The part of an endoscope or endoscope accessory, which allows the
endoscope or endoscope accessory to pass through.
3.9
Insertion portion
The part of an endoscope or an endoscope accessory, which can be inserted into a natural or surgically opened pore of the human body, or inserted into an instrument channel of an endoscope or an endoscope accessory.
3.10
Maximum insertion portion width
The maximum external width of the full length of the insertion portion of the endoscope or endoscope accessory.
3.11
Minimum insertion channel width
The minimum internal width of instrument channel.
3.12
Working length
4 Requirements
4.1 Surface and edge
4.1.1 Endoscopes and endoscope accessories shall be designed to not cause any accidental harm to the human body.
4.1.2 All surfaces of the endoscope and endoscope accessories must not have pores, cracks and burrs.
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.
4.5 Direction of view
If the manufacturer has no other special regulations, the deviation of the direction of view of optical rigid endoscope from the nominal value provided by the manufacturer shall not exceed 10%.
4.6 Funnel-shaped eyepiece cover
The shape and size of funnel-shaped eyepiece cover shall be designed
according to Figure 3. In this way, the eyepiece can be connected to the interfaces of cameras, movie cameras and video cameras produced by many manufacturers.
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.
For flexible endoscopes, the insertion portion shall be placed flat for measurement.
To obtain a millimeter reading:
a) MEASURE the maximum diameter of the circumcircle.
b) If the endoscope uses a detachable cannula, under two conditions of
taking on and taking off cannula, the maximum diameter of the endoscope shall be measured [see Figure 4a) and b)].
c) The unit of measurement is mm.
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.
For flexible endoscopes, the insertion portion shall be placed flat for measurement.
To obtain a French value:
a) If the cross-section of the insertion portion is circular, the French size can be calculated by multiplying the measured diameter by 3.
b) If the cross-section of the insertion portion is non-circular (see Figure 5), 5.4 Field of view and direction of view
5.4.1 Measurement accuracy of field of view
The minimum allowable accuracy of measuring the field of view:
a) ??5% of the reading of rigid endoscope;
b) ??10% of the reading of flexible endoscope.
5.4.2 Measurement accuracy of direction of view
The minimum allowable accuracy of measuring the direction of view:
a) ??3?? for rigid endoscope;
b) ??10?? for flexible endoscope.
5.4.3 Measuring instrument
5.4.3.1 Optical bench, or similar equipment. It can support the optical endoscope for testing; can adjust the central axis of the field of view to coincide with the center of the measuring mark. In the vertical direction, the end face of endoscope lens measures the field of view, at a distance of 50 from the measuring mark center point of the concentric circle marked with an angle. 5.4.3.2 Target holder and dial divided by "degrees" (see Figure 6).
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. For items with unqualified inspection results, it is allowed to take double number of samples for reinspection of unqualified items. If the reinspection is qualified, the product is deemed qualified. If the reinspection is unqualified, then the product is deemed unqualified.
7 Marking
7.1 Least marking
Each endoscope and endoscope accessory shall have the following markings: a) Trademark or other marks indicating the equipment and its manufacturer; b) Maximum insertion portion width, minimum insertion channel width,
working length, field of view, and direction of view. The above marks are necessary for the use of endoscopes and endoscope accessories. The
unit of the width of insertion portion and the width of instrument channel is millimeters (mm). They can also be marked according to the French size
defined in 3.5, indicated by Fr or perimeter value;
c) Whether it is habitual or for some reason, the number of equipment and disassembled parts or semi-disassembled parts shall be indicated in the total or series number.
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
f) User replaceable parts and replacement instructions;
g) Where the user can get the professional services of the equipment;
h) Minimum insertion channel width of each equipment.
8.3 The prevention and application instructions when using the equipment shall include:
a) Liquids suitable and unsuitable for endoscopes, such as control liquid, sclerotherapy liquid, lubricants and anesthetics, and warnings for liquid use;
b) Warning for the use of flammable gases.
9 Packaging, transportation and storage
9.1 There shall be the following markings on the outer packaging box:
a) Name and address of manufacturer;
b) Product name and model;
c) Product standard number;
d) Product registration number;
e) Volume (length??width??height);
f) Gross mass and net mass;
g) Exit-factory year and month;
h) There shall be signs such as "fragile article", "rain-proof", and "upward" in accordance with GB/T 191-2000.
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.
9.4 The transportation requirements are in accordance with the order contract.

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