YY/T 0754-2009 English PDF (YYT0754-2009)

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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 ...