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YY/T 0754-2009: Particular requirements of the safety and essential performance for blood pressure transmission tubes for use with invasive blood pressure monitoring equipment
YY/T 0754-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Particular Requirements of the Safety and Essential
Performance for Blood Pressure Transmission Tubes for
Use with Invasive Blood Pressure Monitoring Equipment
ISSUED ON: NOVEMBER 15, 2009
IMPLEMENTED ON: DECEMBER 1, 2010
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Types ... 6
5 Materials ... 6
6 Physical Requirements ... 7
7 Chemical Requirements ... 9
8 Biological Requirements ... 9
9 Packaging ... 9
10 Labels ... 9
Annex A (Normative) Physical Test ... 11
Bibliography ... 15
Foreword
The Annex A of this Standard is normative.
This Standard was proposed by National Technical Committee on Medical Syringes of
Standardization Administration of China.
This Standard shall be under the jurisdiction of Subcommittee for Standardization of Medical
Electronic Instruments of National Technical Committee on Medical Electronical Appliance of
Standardization Administration of China.
Drafting organization of this Standard: Shandong Inspection Center for Medical Devices.
Chief drafting staffs of this Standard: Wu Ping, Yao Xiujun, Song Jinzi, and Xu Hui.
Particular Requirements of the Safety and Essential
Performance for Blood Pressure Transmission Tubes for
Use with Invasive Blood Pressure Monitoring Equipment
1 Scope
This Standard specifies particular requirements of the safety and essential performance for
blood pressure transmission tubes for use with invasive blood pressure monitoring equipment
(it is referred to as "blood pressure transmission tubes" in this Standard). The tube involved in
this Standard transmits human blood pressure to the blood pressure sensor in an invasive
connection method by an intravascular catheter (for instance connecting the pressure
measurement tube of a central venous catheter to this tube).
This Standard does not involve requirements for other functions on the blood pressure
transmission tubes that are not directly related to blood pressure monitoring. For example, it
has a blood sample collection function.
The particular requirements for electrical safety and performance of sensors used in invasive
blood pressure monitoring devices are specified in other standards.
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments (excluding
corrigendum) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced document
applies.
GB/T 1962.2 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other
medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001, idt ISO 594-2:1998)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-4:2004,
MOD)
YY 0286.4-2006 Special infusion sets - Part 4: Single-use infusion equipment for use with
pressure infusion apparatus (ISO 8536-8:2004, IDT)
YY 0466 Medical devices -- Symbols to be used with medical device labels labelling and
information to be supplied (YY 0466-2003, ISO 15223:2000, IDT)
YY 0585.2-2005 Fluid lines for use with pressure infusion equipment and accessories for
single use - Part 2: Accessories (ISO 8536-10:2004, IDT)
3 Terms and Definitions
For the purposes of this Standard, the following terms and definitions apply.
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.
4 Types
Blood pressure transmission tubes are divided according to the number of points that can
monitor human blood pressure (the number of monitoring channels).
5 Materials
The materials of the liquid channels shall meet the requirements of Clauses 6~9.
6 Physical Requirements
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.
6.8.2 Continuous perfusing
When tested according to A.6.2, the flow rate for continuous perfusing shall be within the
NOTE: To facilitate clinical application, the provided attached color scale indicating the monitoring site
shall be marked in Chinese or English abbreviation next to the color scale to indicate the site to be
monitored.
6.13 Protective cap
It shall meet the corresponding requirements of GB 8368.
7 Chemical Requirements
It shall meet the corresponding requirements of GB 8368.
NOTE: Use one flush set and two transmission tubes in series to prepare the test solution.
8 Biological Requirements
It shall meet the corresponding requirements of GB 8368.
9 Packaging
It shall meet the corresponding requirements of GB 8368.
10 Labels
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);
Annex A
(Normative)
Physical Test
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 ℃ ± 2 ℃ and 40 ℃ ± 2 ℃
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 ℃ ± 2 ℃ and 40 ℃ ± 2 ℃ 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 ℃ ± 2 ℃ 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 ℃ ± 2 ℃ and 40 ℃ ± 2 ℃, 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.