GB 11244-2005General requirements for the medical endoscope and endoscope accessories (English PDF)

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

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.

5.1 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.

6.1 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.

7.1 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.

8.1 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.

9.1 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.

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