YY 0948-2015Cardiopulmonary bypass systems—Arteriovenous cannula for single use (English PDF)

4.2 Physical performance

4.2.1 No leakage

There shall be no leakage in the connection of arteriovenous cannula.

4.2.2 Connection strength

The connections of arteriovenous cannula shall be firm.

4.2.3 Temperature adaptability

The arteriovenous cannula shall not be deformed or broken in the temperature range of 0°C ~ 50°C.

4.2.4 Bending resistance

When the venous cannula is bent, the inner wall shall not be adhered.

Note: This test is not required for arterial cannula.

4.3 Biological performance

4.3.1 Biological evaluation

The arteriovenous cannula shall have no biological hazards.

4.3.2 Sterile

The arteriovenous cannula shall go through confirmed sterilization process to ensure product sterility.

4.3.3 No pyrogen

The arteriovenous cannula shall be no pyrogen.

4.4 Chemical performance

4.4.1 Reducing substance

The difference between the volumes of the potassium permanganate solution [c(KMnO4) = 0.002mol/L] consumed by the 20mL test solution and the same batch of blank control solution shall not exceed 2.0mL.

4.4.2 Heavy metals

5.1 Appearance

Use visual inspection. Requirements of 4.1 shall be met.

5.2 Physical performance

5.2.1 Leakage test

Connect artery cannula channel, seal all outlets, inject air or nitrogen gas which is 50kPa higher than atmospheric pressure, put it into water, keep for 10 min, observe carefully whether there are bubbles escaping from each junction. It shall meet the specifications in 4.2.1.

Fill water in venous cannula, seal all outlets, connect to vacuum pump, keep the pressure 20 kPa below the atmospheric pressure, maintain for 10 min, observe carefully whether there are bubbles entering the venous cannula at each junction. It shall meet the specifications in 4.2.1.

Note: In order to prevent water from entering the vacuum pump, a pipeline without injected water can be used to connect the sample with the machine.

5.2.2 Connection strength test

Apply 15 N axial static tension to each of the junctions of arteriovenous cannula and keep for 15 s. They shall not be separated and shall conform to the specifications in 4.2.2.

5.2.3 Temperature adaptability test

Place the arteriovenous cannula in the environment of 0°C for 3 min, then put in the environment of 50°C for 3 h, and then take back to room temperature for observation. Perform the leakage test of 5.2.1 and the requirements in 4.2.3 shall be met.

5.2.4 Bending resistance test

The length of the test shall be 200 mm. If the length of venous cannula is less than 200 mm, the test length shall be the whole length of the product. Bend the venous cannula as shown in figure 2 and remain for 10 s, visually check it in the bent state. The requirements in 4.2.4 shall be met.

Take products with expiration of no more than 1 month (arbitration, preferred), or age according to YY/T 0681.1-2009. Test 4.2, 4.3.2, 4.3.3, and the results shall conform to 4.7.

6.1 Mark

6.1.1 Product individual package

The individual packaging of each product shall be provided with the following marks.

a) The name of the manufacturer;

b) Product name, model specification;

c) Production batch number, validity period;

d) Words or marks such as "One-time use", "Aseptic", " Prohibit of use in case of packaging breakage", "Please read the instructions before use".

6.1.2 Product external package

The product external packaging shall be provided with the following marks.

a) The name and address of the manufacturer;

b) Product name, model specification;

c) Implementation of the standard number;

d) Product registration number;

e) Production license number;

f) Production batch number;

g) The words or marks of "one-time use" etc.;

h) Sterilization methods; I) The period of validity;

j) Packaging quantity, volume (length×width×height);

k) The words or marks such as "careful and light", "do not press heavily", "fear of moisture", etc., shall conform to the relevant provisions in GB/T […]