YY 1271-2016Cardiopulmonary bypass systems—Suction catheter for single use (English PDF)

4.2.1 Leakage-free

Suction catheter shall be no leakage free.

4.2.2 Connection strength

Suction catheter shall be firmly connected.

4.2.3 Temperature adaptability

The suction catheter shall be free from deformation and rupture in the temperature range of 0 °C ~ 50 °C.

4.2.4 Negative pressure tolerance

Under room temperature conditions, when a negative pressure of 20 kPa (150 mmHg) is applied for 15 seconds, the suction catheter body shall not be flattened.

4.3 Biological properties

4.3.1 Biological evaluation

Suction catheters shall be free of biological hazards.

4.3.2 Sterility

The suction catheter shall be sterilized by the sterilization process that has been confirmed.

4.3.3 Pyrogen-free

The suction catheter shall be pyrogen free.

4.4 Chemical properties

4.4.1 Reducing substances (easily oxides)

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

4.4.2 Heavy metals

When measured by atomic absorption spectrophotometry (AAS) or equivalent method, the total content of bismuth, chromium, copper, lead, and tin in the test solution shall not exceed 1 µg/mL. The content of cadmium shall not exceed 0.1 µg/mL.

When it is subject to visual observation, the suction catheter shall meet the requirements of 4.1.

5.2 Physical properties

5.2.1 Leakage-free

CONNECT the suction catheter passage, LEAD in air or nitrogen gas at a pressure of 50 kPa above atmospheric pressure, PLACE it in water, MAINTAIN it for 10 min, there shall be free from air bubble escape under careful observation. It shall comply with the requirements of 4.2.1.

5.2.2 Connection strength

APPLY the axial static tensile force of 15 N at each joint of the suction catheter for 15 s. It shall be free from separation. It shall comply with the requirements of 4.2.2.

5.2.3 Temperature adaptability

PLACE the suction catheter in a 0°C environment for 3 minutes, then PLACE it in a 50°C environment for 3 hours. After removal, RESTORE it to room temperature for observation, MAKE it subject to the leakage free test of 5.2.1, it shall comply with the requirements of 4.2.3.

5.2.4 Negative pressure tolerance

CONNECT the suction end of the suction catheter to a vacuum source, BLOCK the suction hole, APPLY a negative pressure of 20 kPa for 15 seconds at room temperature. The suction catheter body shall not be flattened, it shall comply with the provisions of 4.2.4.

5.3 Biological properties

5.3.1 Biological evaluation

The biological properties shall be evaluated in accordance with the provisions of GB/T 16886.1.

5.3.2 Sterility test

The sterilization process shall be confirmed in accordance with relevant standards such as GB 18279 or GB 18280.

Sterility test is performed in accordance with the provisions of GB/T 14233.2-2005, the method should not be used for exit-factory inspection.

5.5 Corrosion resistance

Take out the metal parts, make it subject test in accordance with the sodium chloride solution test method in YY/T 0149-2006, the results shall comply with the provisions of 4.5.

5.6 Particle contamination

The test shall be conducted in accordance with the provisions in Appendix A of GB 19335-2003, it shall comply with the provisions of 4.6.

5.7 Validity period test

Take the products that have expired not exceeding one month (arbitration method, which is preferred), or perform aging in accordance with the provisions of YY/T 0681.1-2009, to test the items of 4.2, 4.3.2, 4.3.3, the results shall comply with the requirements of 4.7.

6.1 Marking

6.1.1 The product packaging shall have the following markings.

a) The name of the manufacturer;

b) The product name, model specifications;

c) The production lot number, validity period;

d) Words or illustrations such as "for single-use", "sterility", "do not use if package broken", "please read manual before use", etc.

6.1.2 Product packaging shall have the following markings.

a) Manufacturer's name, address;

b) Product name, model specifications;

c) Implemented standard number;

d) Product registration number;

e) Production license number;

f) Production lot number;