YY/T 0754-2009Particular requirements of the safety and essential performance for blood pressure transmission tubes for use with invasive blood pressure monitoring equipment (English PDF)

3.1 Liquid tube

The collective name for all parts of the blood pressure transmission tube that are in contact with the perfusate.

3.2 Flush set

The part of the tube in the blood pressure transmission tube used to inject perfusate (a mixture of physiological saline and heparin) into the dome and the blood pressure transmission tube.

3.3 Flush valve

The device in the blood pressure transmission tube, which is located between the dome and the flush set, and is used to control the perfusate flow rate of the flush set into the system. The valve has two working states, namely, fast perfusing state and operating state.

NOTE: Some flush sets are also designed with a pressure relief function. When the pressure in the dome is too high, the flush valve will open in reverse, reducing the pressure inside the pressure chamber, thereby protecting the pressure sensor device.

3.4 Dome

The chamber where the sensing element of the pressure sensor is located.

3.5 Transmission tube

The tube in the blood pressure transmission tube that is used to connect the dome with the patient's intravascular equipment (excluded in this blood pressure transmission tube) and to correctly transmit the patient's blood pressure to the dome.

3.6 Cap with hole

There is a vent hole, a cap that is used to remove air bubbles from the blood pressure transmission tube during the perfusing process.

3.7 Cap without hole

There is no vent hole, a cap that isolate the blood pressure transmission tube from the outside world during the pressure monitoring process of the blood pressure transmission tube (see 3.8 NOTE).

NOTE: The cap is different from the protective cap. The protective cap needs to be removed before use, while the cap remains in contact with the liquid in the system during use.

3.8 Protective cap

It is a component that protects the internal sterility of the liquid path before use and needs to be removed before use.

NOTE: Unlike the cap, the cap will come into contact with the perfusate during use, while the protective cap does not come into contact with it.

3.9 Patient end

The end of a blood pressure transmission tube or component that is relatively close to the patient in the direction of fluid flow during normal use.

3.10 Running state

After the flush set has completed the process of filling the inner cavity of the blood pressure transmission tube with the perfusate and removing the air bubbles in the blood pressure transmission tube, then use cap without hole to block each exhaust port to make it in a blood pressure monitoring state.

NOTE: Water is used instead of perfusate during the test of this Standard.

3.11 Flow rate for running

The perfusing flow rate of the flush set during the operation process.

6.1 Transparency

The liquid tube shall be transparent or sufficiently transparent. When tested according to the provisions of Clause A.1, the gas-liquid interface shall be detected.

6.2 Particulate contamination

When tested according to the provisions of Clause A.2, the pollution index shall not exceed 90.

6.3 Connection strength

When tested according to the provisions of Clause A.3, all connecting parts of the liquid tube shall be able to withstand a static tension force of at least 15N for 15s without falling off or disconnecting.

6.4 Leakage

When tested according to the provisions of Clause A.4, there shall be no gas or liquid leakage.

6.5 Connectors with inner and/or outer conical joints

6.5.1 The inner and outer conical joints on the connector shall comply with the provisions of GB/T 1962.2.

6.5.2 When tested according to the provisions of Clause A.5, there shall be no liquid leakage at the connection.

6.6 Switch

The switches in the liquid tube shall meet the requirements of 5.7 in YY 0585.2-2005.

6.7 Flush set

The flush set shall meet the requirements of the liquid medicine filter (6.6), cork piercer (6.8), dripper and dropper (6.10), and flow regulator (6.12) specified in YY 0286.4-2006.

6.8 Flush valve

6.8.1 Fast perfusing

When tested according to A.6.1, the perfusion shall be completed within 5 min.

6.13 Protective cap

It shall meet the corresponding requirements of GB 8368.

10.1 General rules

The graphic symbols given in YY 0466 may be used to meet the requirements of 10.2 and 10.3 of this Standard.

10.2 Single packaging container

Single packaging shall be marked with at least the following information:

a) Text description of contents;

b) Instructions on sterility of the liquid tube;

c) Text description indicating that the liquid tube is free of pyrogens or bacterial endotoxins;

d) For one-time use only, or words of equivalent meaning;

e) Instructions for use, including warnings, such as checking whether the protective cap has fallen off (the instructions for use can also be in the form of inserts);

A.1 Transparency test

Fill the liquid tube with distilled water; and use normal or corrected vision to check whether the gas liquid interface is visible.

A.2 Particulate contamination test

The test shall be carried out in accordance with the provisions of GB 8368. But make the following changes:

Take three sets of blood pressure transmission tubes and flush the inner cavity of the blood pressure transmission tubes with 500mL of flushing solution through the flush set. For multi-channel blood pressure transmission tubes, the volume of flushing solution shall be evenly distributed to each tube. Collect the flushing solution for testing.

A.3 Connection strength test

Make each joint of the test liquid tube bear an axial static tensile force of 15N for 15s. Check whether the joints can withstand the applied forces.

A.4 Leakage test

A.4.1 Test preparation

Before starting the test, place the entire blood pressure transmission tube at the test temperature for state adjustment, and then proceed according to A.4.2 ~ A.4.4.

A.4.2 Air pressure test

Seal each exhaust port of the liquid tube by the attached cap without hole; and use a suitable method to block the liquid inlet end of the flush set. Connect the patient end of the transmission tube to the compressed air source; and make the flush valve in fast perfusing state, fill the pressure 50kPa higher than the atmospheric pressure in water at 23 °C ± 2 °C and 40 °C ± 2 °C for 15 s; and check whether there is gas leakage in the liquid tube.

A.4.3 Hydraulic test

Use a flush set to fill the liquid tube with distilled water according to the instructions for use; and discharge the air in the liquid tube. Seal each exhaust port of the liquid tube by the attached cap without hole; and use a suitable method to block the liquid inlet of the flush set; put the flush valve in the fast-perfusing state; and introduce a pressure of 200kPa from the patient end of the transmission tube at 23 °C ± 2 °C and 40 °C ± 2 °C respectively for 15 min to check whether there is water leakage in the liquid tube.

A.4.4 Vacuum test

Remove all air bubbles in the liquid tube by water; seal the liquid tube by the attached cap without hole; and use a suitable method to block the inlet end of the flush set. Connect the patient end of the transmission tube to a vacuum device to make the flush valve in a fast-perfusing state, and it is subjected to a pressure of -20kPa for 1 min at 23 °C ± 2 °C to check whether air enters the liquid tube.

A.5 Test of connectors with inner and outer conical joints

A.5.1 Before starting the test, place the entire blood pressure transmission tube at the test temperature for condition adjustment.

A.5.2 Use standard connectors that comply with the provisions of GB/T 1962.2 to test the inner and/or outer conical joints of the connector. At 23 °C ± 2 °C and 40 °C ± 2 °C, use distilled water to introduce a pressure of 200kPa higher than the atmospheric pressure into the interior for 15 min; and check whether there is water leakage at the joint.

A.6 Flush valve test

A.6.1 Fast perfusing

Follow the instructions for use, connect the flush set to the infusion container; open the flow regulator of the flush set to the maximum; and use a timer to record the total time it takes for the flush set to inject distilled water into each transmission tube and discharge air bubbles.

NOTE: If there is no flush set, use the device specified by the manufacturer (such as an infusion set that meets the requirements of GB 8368) as the flush set.

A.6.2 Continuous perfusing

After completing A.6.1, under the pressure conditions specified by the manufacturer, use a timer and weighing instrument to check the volume of liquid flowing out of the patient end of each transmission tube under operating conditions; and calculate whether the flow rate meets the nominal value.

A.7 Transmission tube test

A.7.1 Test conditions

In the running state, remove the flush set from the flush valve, and use cap without hole to block the liquid inlet and exhaust ports of the flush valve. […]