YY 0068.2-2008Medical endoscopes—Rigid endoscope - Part 2: Mechanical properties and test methods (English PDF)

3.1 Endotherapy device

It refers to the medical device entering into the human body's natural orifice or surgical incision via the channel which is the same with or different from that of the endoscope during the endoscopic surgery, for the purposes of examination, diagnosis or treatment.

3.2 Instrument channel

It refers to a part of the endoscope or endotherapy device. According to the provisions, the endoscope or endotherapy device shall penetrate via this part.

3.2.1 Minimum instrument channel width

It refers to the minimum internal width of the instrument channel.

3.3 Insertion portion

It refers to a part of the endoscope or endotherapy device, which can be inserted in the human bodies' natural orifices or surgical incisions, or the instrument channels of endoscopes or endotherapy devices.

4.1 Dimensions

4.1.1 Working length L

The permissible error of the nominal value of the endoscope's working length shall be ± 3%.

4.1.2 Maximum insertion portion width

The maximum insertion portion width of the endoscopes shall not be greater than the dimensions specified in the instructions provided by the manufacturing plant.

4.2 Coordination

4.2.1 Locking, insertion-demolition

If the endoscope needs to be coordinated with the sheath, or with the bridge and sheath in the clinical application, the locking, insertion-demolition between the two shall conform to the following requirements. […]

4.2.2 Positioning and sealing

For the endoscope that needs to coordinate with the sheath, or with the bridge and sheath in the clinical application, MEET the following requirements after coordination.

4.3 Encapsulation

4.3.1 Fog layer

For the endoscopes containing optical elements, CLEAN and DRY the sealed interior. After the sudden change test from low temperature to high temperature, there shall be no blurry field of view.

4.6 External surface quality of the insertion portion

Except for special purposes, the insertion portions shall have no safety hazards that might be caused.

5.2 Coordination inspection

5.2.1 Tests for locking, insertion and demolition

5.2.1.1 Equipment

Standard tension meter, or other equivalent tools.

The minimum reading of the measuring tool shall be greater than 10% of the required minimum reading.

5.2.1.2 Environmental conditions

At room temperature.

5.3 Encapsulation inspection

5.3.1 Fog layer test

5.3.1.3.7 CLEAN the external surfaces of the optical parts according to the routine method.

5.3.1.1 Equipment

One temperature regulating water bath. The maximum controllable water temperature shall not be lower than 50°C. The temperature regulating accuracy shall be greater than ± 1°C.

5.3.1.3.8 OBSERVE

and INSPECT the image planes of the distal endoscopes towards the bright sky.

5.4 Strength and stiffness tests

5.4.1 Strength test

CONDUCT the maximum force or torque test according to the methods indicated by the manufacturer. If the manufacturer indicates no methods, SELECT the point of force application and the direction according to the worst conditions.

5.4.2 Stiffness test

CONDUCT the maximum deflection and force tests according to the methods indicated by the manufacturer. If the manufacturer indicates no methods, APPLY force to the direction perpendicular to the initial mechanical axis at the farthest end according to the way of cantilever beam, so as to conduct the maximum deflection test.

5.5 Connection inspection

USE visual observation combined with the hand-feeling inspection for verification.

5.6 External surface quality of the insertion portion

USE visual observation, hand-feeling test, or the method of wiping by using a cotton ball to check whether there are draglines for inspection and verification. […]