YY/T 0285.6-2020Intravascular catheters—Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (English PDF)

4.1 General

Unless otherwise specified in this part, subcutaneous implanted ports and catheters shall comply with the requirements of YY 0285.1-2017.

4.2 Biochemical properties

4.2.1.1 General: the subcutaneous implanted port shall be free of biological hazards.

Note 1: See GB/T 16886.1 for biological evaluation.

Note 2: Demonstrating that the implant materials meet the corresponding standards (such as YY 0334, ISO 5832, YY/T 1557 and YY/T 0660) helps to support the biological evaluation required by GB/T 16886.1.

4.2.1.2 Bacterial endotoxin: inject not more than 10 mL of water for bacterial endotoxin test into each port set and extract at (37 ± 1) °C for (1 ± 0.1) h. Test in accordance with the bacterial endotoxin test of the Pharmacopoeia of the People's Republic of China, 2015 Edition. The bacterial endotoxin content shall be less than 0.5 EU/mL.

Note: See YY/T 0618 for the routine testing of bacterial endotoxin.

4.2.2.1 Silicone rubber elastic parts: the silicone rubber elastic parts of the port shall meet the requirements of 5.3 and 5.4 of YY 0334-2002.

4.2.2.2.1 Test solution preparation (components other than silicone rubber elastic parts): extract 0.2 g of sample per 1 mL of water complying with GB/T 6682 at (37 ± 1) °C for 72 h to obtain the test solution. Prepare the blank control solution in the same way.

4.2.2.2.2 pH: when tested by the method of 5.4.1 of GB/T 14233.1-2008, the pH of the test solution shall not differ from that of the blank control solution by more than 1.0.

4.2.2.2.3 Metal ions: when determined by atomic absorption spectrophotometry or an equivalent method (5.9.1 or 5.6.1 of GB/T 14233.1-2008), the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 1 µg/mL and the content of cadmium shall not exceed 0.1 µg/mL.

4.2.2.2.4 Reducing substances: when tested by the indirect titration method of 5.2.2 of GB/T 14233.1-2008, the difference in the volume of potassium permanganate solution [c(KMnO4) = 0.002 mol/L] consumed by the test solution and the blank control shall not exceed 2.0 mL.

4.2.2.2.5 UV absorbance: when tested by the method of 5.7 of GB/T 14233.1-2008 over 250 nm to 320 nm, the absorbance of the test solution shall not be greater than 0.1.

4.2.2.2.6 Evaporation residue: when tested by the method of 5.5 of GB/T 14233.1-2008, the evaporation residue shall not exceed 2 mg.

4.2.2.3 Residual ethylene oxide: if the port is sterilized with ethylene oxide, when tested by the gas chromatography method of Clause 9 of GB/T 14233.1-2008, the residual ethylene oxide shall not exceed 0.5 mg per port.

4.3 Distance mark

If the catheter carries distance marks, they shall indicate: a) for a split catheter, the distance from the end of the catheter; b) for a pre-connected catheter, the distance from the proximal end of the catheter.

From the first mark, the distance between marks shall not be greater than 5 cm.

4.5 Physical requirements

4.5.5.2 Self-sealing after puncture: when tested by the method of Annex D, the septum of the port shall show no gas leakage.

4.5.5.3 Puncture chips: when tested in accordance with Annex E, after 1,000 punctures per cm2 of septum or the nominal number of punctures, whichever is greater, the number of chips shall not exceed 30.

4.5.6.1 Peak tension: when tested in accordance with Annex F, the minimum peak tensile force of the connection between port and catheter shall be 5 N; the other parts of the catheter shall meet 4.4 of YY 0285.3-2017.

4.5.6.2 Bending resistance: when tested in accordance with Annex G, the flow rate of the bent catheter shall be not less than 50 % of that of the straight catheter.

4.5.6.3 Dynamic breaking strength: the connection between port and catheter, and each connection of the catheter, shall withstand 100,000 cycles at (1 ± 0.2) Hz, stretched in the flow direction to 10 % elongation or to a maximum force of 5 N, whichever is reached first, without any component breaking or cracking. Split catheters shall also meet this requirement after being connected to the port according to the manufacturer's instructions.

4.6 Flow

4.6.1 General: if a nominal flow rate is marked, when ports not intended and intended for power injection are tested by the methods of Annexes E and G of YY 0285.1-2017, the flow rate of each lumen shall be not less than 80 % of the manufacturer's nominal value for catheters with a nominal outside diameter below 1.0 mm, and not less than 90 % for catheters of 1.0 mm or more. For hydrating catheters, the flow rate shall be measured after hydration.

4.6.2 Ports indicated not to be used for power injection: the test of Annex E of YY 0285.1-2017 is carried out with the non-coring needle connected to the Luer connector, placed through the septum, the port connected to the test catheter, and the in-line pressure sensor at the proximal end of the needle. Results are expressed as the minimum and maximum gravity flow; the needle gauge and length are recorded.

4.6.3 Ports indicated to be used for power injection: the test of Annex G of YY 0285.1-2017 is carried out with the locking device connected to the hub of the power-injection non-coring needle, the needle placed through the septum and the port connected to the test catheter.

4.7 Burst pressure for subcutaneous implanted ports and catheters

4.7.1 General: the test is carried out by the method of Annex F of YY 0285.1-2017, with the locking device accessories connected to the hub of the non-coring needle as justified by a risk-based clinical rationale.