YY 0325-2016Sterile urethral catheter for single use (English PDF)

3.1

Annex A (normative)

Test method for determining urethral catheter strength

A.1 Principle

Urethral catheters with balloon may be used in situ for long periods of time.

Therefore, for urethral catheters with balloon, the urethral catheter is immersed in simulated urine for 14 days before the test. For urethral catheters without balloon, this step may be omitted. A tension is applied to the junction between the tip and the shaft of the urethral catheter. For urethral catheters with side holes, tension is applied to the holes; for catheters without side holes, tension is applied between the shaft and the drainage conical interface. After remove the tension, check the urethral catheter for signs of destruction.

A.2 Reagents

A.2.1 Simulated urine may use either of the following two formulas.

a) Simulated urine consists of the following components (pH is about 6.6).

The reagents are analytical reagents.

Urea 25.0 g

Sodium chloride 9.0 g

Anhydrous disodium phosphate 2.5 g

Ammonium chloride 3.0 g

Anhydrous potassium dihydrogen phosphate 2.5 g

Creatinine 2.0 g

Sodium sulfite, anhydrous 3.0 g

Distilled water dilute to 1.0 L

Warning. This solution helps the growth of microorganisms. At the end of the tests described in A.3 and C.3, there is likely to be a large amount of microorganisms. These tests shall be carried out by trained personnel.

Appropriate preventive measures shall be taken when handling the soaked urethral catheter and discarding the contaminated solution.

b) Simulated urine consists of the following components (pH is about 5.5 ~

Annex B (normative)

Test method for determining the assembly separation force of drainage conical interface

B.1 Principle

CONNECT the specified test connector to the drainage conical interface of the urethral catheter; APPLY an axial tension; CHECK if the connection is separated.

B.2 Instruments

B.2.1 Test connector, made of rigid material, dimensions are shown in Figure

B.1a).

B.2.2 Fixture or similar devices, for suspending urethral catheters.

B.2.3 Connection device for weights and test connector

For urethral catheters with a specification of 3.3 mm or less, the total mass of the connection device and the weight is 0.75 kg; for urethral catheters with a specification greater than 3.3 mm, the total mass of the connection device and the weight is

1 kg.

B.2.4 Timer.

B.3 Procedure

The test is performed at (23 ± 2) °C.

Allow the urethral catheter's drainage conical interface and connector (B.2.1) to clean and dry.

PLUG the connector into the drainage conical interface to a depth of 10 mm or more (i.e., reach or exceed the marking on the connector).

SELECT a point from the connection between the drainage conical interface and the shaft, CLAMP with a clamp (B.2.2), SUSPEND the urethral catheter (see Figure B.1b)].

HOLD the weight (B.2.3), on the drain cone of the urethral catheter and gently place the weight down until it is suspended from the urethral catheter. Hold it for 1 min and observe.

RECORD whether the test connector is separated from the conical interface.

in the range, it shall be filled up to the maximum capacity.

The urethral catheter is immersed in freshly prepared simulated urine (C.2.2) and placed in the water bath (C.3.3) controlled at (37 ± 2) °C, to completely immerse the tip and the balloon.

REMOVE the urethral catheter after being immersed for 14 days in simulated urine; RINSE with tap water and allow it to dry; PLACE the urethral catheter at a temperature of (23 ± 2) °C.

PLACE the urethral catheter in the suspension device (C.3.1) with the tip facing up; ALLOW the balloon to sit in the counterbore, and the shaft to pass through the hole in the plate.

NOTE. For suspension device that cannot be separated from the middle, to facilitate the insertion of the urethral catheter into the suspension device, it may cut the conical interface if necessary, or fill the balloon after passing through the urethral catheter.

SELECT the weight suitable for the test urethral catheter according to Table

C.1.

HOLD the weight, CONNECT it to the shaft or conical interface of the urethral catheter. PUT the weights down lightly until it is free to suspend on the urethral catheter, KEEP for 1 min.

During the weight suspension, visually inspect the urethral catheter.

a) Whether the drain hole (if any) is affected by the balloon.

b) Whether the balloon leaks.

C.5 Test report

The test report shall include the following information.

a) urethral catheter identification;

b) whether the drain hole is affected by the balloon;

c) whether the balloon leaks.

Annex D (normative)

Test method for determining leakage and/or function of filling cavity and balloon retraction

D.1 Principle

The balloon and filling cavity of the urethral catheter are filled with water and immersed in simulated urine for 14 days. The water in the balloon is released under gravity. The capacity of the recovered liquid is measured.

D.2 Instruments and reagents

D.2.1 Fixture or similar devices, for clamping the tip of the urethral catheter, suspending the urethral catheter.

D.2.2 6 % (Luer) outer conical fitting, in accordance with GB/T 1962.1, such as a piston-removal syringe.

D.2.3 Water bath, or other device capable of controlling the temperature at (37

± 2) °C.

D.2.4 Measuring cylinder, with an accuracy of ±1 %, the specification is compatible with the balloon.

D.2.5 Distilled water.

D.2.6 Simulates urine, the composition is the same as A.2.1.

D.3 Procedure

Through the valve of the filling conical interface, FILL the balloon with distilled water (D.2.5) of the capacity specified in Table D.1.

The urethral catheter is immersed in simulated urine (D.2.6) and soaked in the (37 ± 2) °C water bath for 14 days.

REMOVE the urethral catheter, RINSE it with tap water and allow it to dry.

INSERT the Luer outer conical fitting (D.2.2) into the filling conical interface;

DRAIN the liquid in the balloon; the effluent liquid flows into the measuring cylinder until no more liquid has flowed out or 15 minutes, whichever is shorter.

MAKE the temperature of the liquid in the measuring cylinder (D.2.4) reach (23

± 2) °C; MEASURE the capacity of the balloon; CALCULATE the recovery

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