YY 0285.5-2018Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (English PDF)

3.1 Over-needle peripheral intravascular catheter

A catheter for introducing in or withdrawing out a fluid or instrument from a peripheral vascular system.

3.2 Needle

Appendix A (Normative)

Determination of connection strength between needle hub and needle tube

A.1 Principle

Apply tension and compression to the needle tube and the needle hub, then check for loose connections between the needle tube and the needle hub.

A.2 Instrument

The tensile tester can apply a force of 20 N with an accuracy of ±1%.

A.3 Test procedure

A.3.1 Condition the needle for 2 h under conditions of relative humidity of 40%

~ 60% and temperature of 22 °C ± 2 °C, immediately perform the test.

A.3.2 Clamp the needle tube and the needle hub on the fixture of the tensile tester, then apply the tension and pressure one time at the speed of 100 mm/min in accordance with the following force values.

- The test needle with a nominal outer diameter less than 0.6 mm. 10 N;

- The test needle with the nominal outer diameter greater than or equal to

0.6 mm. 20 N.

A.3.3 Check the connection between the needle tube and the needle hub, record whether the needle is loose.

A.4 Test report

The test report shall include the following information.

a) Identification of the needle;

b) The outer diameter of the needle, expressed in mm;

c) The applied force (i.e. 10 N or 20 N);

d) Whether the needle in the needle hub loosens.

Appendix D (Normative)

Determination of liquid leakage from vent fittings

D.1 Principle

The catheter is connected to a simulated blood source under hydrostatic pressure. Allow liquid to flow into the needle and measure the time it takes for the liquid to leak through the vent fitting.

D.2 Test solution

D.2.1 Dissolve 9 g of analytically pure sodium chloride in distilled or deionized water to prepare 1 L sodium chloride solution [0.9% (mass concentration)].

D.2.2 Mix 550 mL of sodium chloride solution (D.2.1) and 450 mL of USP grade or higher glycerin to prepare test solution.

Note. To improve the observability, a coloring agent such as a red or blue food coloring agent may be added.

D.3 Instrument

D.3.1 Constant liquid level container, capable of providing 400 mm ± 20 mm static pressure head, equipped with a liquid supply pipeline with an inner diameter of not less than 3 mm, the liquid supply pipeline is equipped with a clip or valve, the end has a puncture membrane such as latex cover). An example of this device is shown in Figure D.1.

D.3.2 Stopwatch, or similar device.

D.4 Procedure

D.4.1 Fill the test solution (D.2) at 23 °C ± 2 °C into a constant liquid level container (D.3.1).

D.4.2 Discharge all air in the supply line and close the clamp or valve.

D.4.3 Insert the needle tip into the membrane to ensure that the needle is maintained at ±5° from the horizontal plane.

D.4.4 Open the clamp or valve to allow liquid to flow into the needle tube and measure the time it takes for the first drop to drop at the vent fitting.

D.5 Test report

YY/T 0285.6-2020 | YY 0285.1-2017 | YY 0285.3-2017 | YY 0285.4-2017 | YY/T 0294.1-2024 | […]