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YY 0285.4-2017: Intravascular catheters—Sterile and single-use catheters—Part 4: Balloon dilatation catheters
YY 0285.4-2017
Intravascular catheters-Sterile and single-use catheters-Part 4. Balloon dilatation catheters
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0285.4-1999
Endovascular catheter single-use sterile catheter
Part 4. balloon dilatation catheter
Part 4. Baloondilatationcatheters
(ISO 10555-4..2013, MOD)
2017-07-17 release
2019-01-01 Implementation
Published by the State Food and Drug Administration
Foreword
YY 0285 "Intravascular Catheters Disposable Sterile Catheters" consists of four parts.
--- Part 1. General requirements;
--- Part 3. Central venous catheter;
--- Part 4. balloon dilatation catheter;
--- Part 5. trocar peripheral catheter.
This part is Part 4 of YY 0285.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0285.4-1999 "Disposable sterile intravascular catheters Part 4. Balloon dilatation catheter", and YY 0285.4-
The main technical changes compared to.1999 are as follows.
--- Updated normative references;
--- Added requirements and test methods for the rated burst pressure of the balloon, the pressure relief time of the balloon, and the relationship between the diameter of the balloon and the filling pressure.
This part uses the redrafting method to modify the use of ISO 10555-4..2013 "Intravascular catheters disposable single-use sterile catheters Part 4
Points. Balloon Dilatation Catheter.
The technical differences between this section and ISO 10555-1..2013 and their causes are as follows.
--- Regarding the normative references, this standard has made adjustments with technical differences to suit China's technical conditions and the situation of adjustment.
The situation is reflected in Chapter 2 "Regulatory Reference Documents", and the specific adjustments are as follows.
● Replaced ISO 594-1 with GB/T 1962.1 equivalent to the international standard;
● Replaced ISO 594-2 with GB/T 1962.2 equivalent to the international standard;
● Replaced ISO 10555-1 with YY 0285.1 equivalent to the international standard.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by the State Food and Drug Administration.
This section is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Lepu (Beijing) Medical Devices Co., Ltd., Cook (China
(China) Medical Trade Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Shandong Ruiantai Medical Technology Co., Ltd.
The main drafters of this section. Wan Min, Liu Weijun, Fang Yuan, Liu Xin, Chen Huimin, Zhang Haijun.
The previous versions of the standards replaced by this section are.
--- YY 0285.4-1999.
Endovascular catheter single-use sterile catheter
Part 4. balloon dilatation catheter
1 Scope
This part of YY 0285 specifies requirements for balloon dilatation catheters that are supplied sterile and for single use.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.1 Syringes, needles and other medical devices 6% (Luer) conical joints Part 1. General requirements
(GB/T 1962.1-2015, ISO 594-1. 1986, IDT)
GB/T 1962.2 Syringes, needles and other medical devices 6% (Luer) conical joints Part 2. Locking cone
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
YY 0285.1 Disposable sterile catheters for intravascular catheters Part 1. General requirements (YY 0285.1-2017,
(ISO 10555-1..2013, MOD)
3 Definition
The terms and definitions defined in YY 0285.1 and the following apply to this document.
3.1
Balloon dilatation catheter baloondilatationcatheter
A balloon is installed near the end and an artery or vein is inserted to dilate one or more intravascular catheters in the vascular system.
4 Requirements
4.1 General
Unless otherwise specified in this part of YY 0285, balloon dilatation catheters shall meet the requirements of YY 0285.1.
4.2 Ray detectability
When the catheter is inserted into the body, the position of the balloon should be detectable by radiation.
4.3 Identification of nominal specifications
The nominal specifications of the catheter shall be identified as follows.
a) the diameter of the filled balloon in millimeters; for balloons with multiple diameters, the diameter of each part under the recommended pressure is marked
b) the effective length of the balloon at the recommended pressure;
c) the maximum diameter of the guide wire used with the catheter, if applicable.
Note. When a balloon dilatation catheter (see Figure B.1) is used as a stent delivery system, refer to the appropriate stent standard to determine the nominal size identification.
4.4 Physical requirements
4.4.1 Balloon rated burst pressure (RBP)
When determining the burst pressure according to Appendix A, the rated burst pressure should have a suitable safety margin. Axial failure is the desired failure mode.
4.4.2 Balloon fatigue; no leaks or damage during filling
When evaluating the balloon's ability to withstand repeated cycles of filling to its rated burst pressure (RBP) as described in the test in Appendix B, the catheter should not have
Leaks or damage (such as protrusions or bursts).
4.4.3 Balloon decompression time
Determine the time required for the balloon from RBP to the end of the pressure relief as described in Appendix C.
4.4.4 Relationship between balloon diameter and filling pressure
The relationship between balloon diameter and balloon filling pressure was determined as described in Appendix D.
4.5 Information provided by the manufacturer
The information provided by the manufacturer shall meet the requirements of YY 0285.1, and shall also include the following information.
a) the nominal size of the catheter, identified according to 4.3;
b) the position of the mark detectable by the radiation;
c) the rated burst pressure of the balloon, expressed in kilopascals;
d) the filling pressure required for the balloon to reach its nominal diameter, expressed in kilopascals;
e) Appropriate guidewires intended for clinical use, guidelines for compatibility of catheters or sheaths or guiding devices, and specification recommendations.
Note. Units of measurement other than those specified in this section may be used in addition.
Appendix A
(Normative appendix)
Balloon rated burst pressure (RBP) test
A.1 Principle
The purpose of this test was to determine the RBP of the balloon.
A.2 Instrument
A.2.1 Recommended guide wire or equivalent.
A.2.2 Water bath, control at (37 ± 2) ℃.
A.2.3 Methods for measuring leakage, such as test solution with dyeing solution, pressure drop monitoring device, flow rate monitoring device.
A.2.4 Filling liquid, such as room temperature water or other reasonable clinically relevant media.
A.2.5 Timing device, meet the accuracy specified in the test.
A.2.6 Pressure generating device, equipped with a measuring device with a reading pressure accuracy of ± 5% and capable of maintaining filling pressure, and equipped with GB/T 1962.1
Or 6% (Luer) inner conical joint of GB/T 1962.2 (if applicable), used to connect with the test tube.
A.3 Test procedure
A.3.1 Fill the pressure generating device (A.2.6) with liquid for filling.
A.3.2 If it is specified in the instruction manual that the guide wire should be used when the balloon is filled, insert a suitable guide wire into the device (A.2.1).
A.3.3 Connect the pressure generating device to the test catheter, and at least immerse the balloon in a water bath (A.2.2) at (37 ± 2) ℃.
A.3.4 Allow the catheter to equilibrate for at least 2 min.
A.3.5 Fill the balloon at a predetermined boost rate until the catheter bursts or is damaged. Record blast pressure, failure mode, and location of failure.
A.4 Test report
The test report should include the following information.
a) identification of the catheter;
b) the average burst pressure, RBP and the maximum, minimum and standard deviation of burst pressure data, expressed in kilopascals;
c) all observed modes of failure.
Note. Units of measurement other than those specified in this section may be used in addition.
Appendix B
(Normative appendix)
Fatigue test of balloon without leakage and damage during filling
B.1 Principle
Simulates the number of filling and retracting of the catheter during use in the body. Inspect the catheter for leaks, ruptures, or protrusions when full.
B.2 Instrument
B.2.1 Recommended guidewire or equivalent.
B.2.2 Water bath, control at (37 ± 2) ℃.
B.2.3 Leak measurement methods, such as test solution with dyeing solution, pressure drop monitoring device, flow rate monitoring device.
B.2.4 Timing device, meet the accuracy specified in the test.
B.2.5 Filling syringe or equivalent device, equipped with a measuring device with a reading pressure accuracy of ± 5% and capable of maintaining the filling pressure, and equipped with
GB/T 1962.1 or GB/T 1962.2 6% (Luer) inner conical joint (if applicable) is used to connect with the test tube.
B.2.6 Compliance tubing (if applicable, with compliance to clinical and use principles, such as when measured in a stent), its diameter represents
The recommended vessel diameter for the test catheter, so that the instrument does not move significantly during the filling cycle.
B.3 Test procedure
B.3.1 Fill the filling device (B.2.5) with water or other clinically relevant media (the media selected must be justified).
B.3.2 If it is specified in the instruction manual that the guide wire should be used when the balloon is filled, insert a suitable guide wire into the device (B.2.1).
B.3.3 Connect the balloon filling device to the test catheter, and at least immerse the balloon in a water bath (B.2.2) at (37 ± 2) ℃. If you use
Should be piped, insert the instrument into the compliance pipe.
B.3.4 Allow the catheter to equilibrate for at least 2 min, and then fill it to the balloon's rated burst pressure. Hold at this filling pressure for at least 30s. Then make
Decompress the balloon. Repeat this step 8 times. Observe the leak.
B.3.5 After completing 9 filling/relieving pressures according to B.3.4, fill again to the balloon's rated burst pressure, remove the catheter from the water bath, and keep the balloon filled
Profit status.
B.3.6 Inspect the entire catheter for leaks, ruptures, protrusions, any direction of balloon rupture, and if any rupture has occurred, if any debris has occurred.
B.4 Test report
The test report should include the following information.
a) identification of the catheter;
b) the filling pressure used, expressed in kilopascals;
c) whether the conduit has leaked;
d) Whether the catheter body or balloon has ruptured or protruded, any direction of balloon rupture, and if there is any fragmentation in the rupture.
Note. Units of measurement other than those specified in this section may be used in addition.
Explanation.
1 --- catheter reinforcements;
2 --- coupling;
3 --- catheter holder;
d --- balloon diameter after filling;
l1 --- the effective length of the balloon;
l2 --- The effective length of the catheter.
Note. This figure shows the size identification of the catheter, and the parts are only schematic.
Figure B.1 Dimensioning of a balloon dilatation catheter
Appendix C
(Normative appendix)
Balloon decompression time test
C.1 Principle
The purpose of this test is to determine the time required to decompress the balloon from the rated burst pressure (RBP) level. This test can be a clinical treatment
Cases (such as potential block times) provide useful information.
C.2 Instrument
C.2.1 Recommended guidewire or equivalent.
C.2.2 Water bath, control at (37 ± 2) ℃.
C.2.3 filling medium, filling medium related to clinical use or according to the instruction manual.
C.2.4 Timing device to meet the accuracy specified in the test.
C.2.5 Filling syringe or equivalent device, equipped with a measuring device with a reading pressure accuracy of ± 5% and capable of maintaining the filling pressure, and equipped with
GB/T 1962.1 or GB/T 1962.2 6% (Luer) inner conical joint (if applicable) is used to connect with the test tube.
C.2.6 For rigid tubing (if appropriate), its diameter represents the maximum recommended vessel diameter for the compliant balloon.
C.3 Test procedure
C.3.1 Inject the medium into the balloon filling device (C.2.5) according to the instruction manual.
C.3.2 Insert a suitable guide wire into the test catheter (C.2.1).
C.3.3 Connect the balloon filling device to the test catheter and at least immerse the balloon in a water bath (C.2.2) at (37 ± 2) ℃. Test guide
Insert the pipe into a rigid pipe (C.2.6) (if applicable).
C.3.4 Allow the catheter to equilibrate for at least 2 min.
C.3.5 Fill the balloon to RBP in accordance with the instructions to simulate clinical use.
C.3.6 Decompress the balloon according to the instruction manual, and use the timer (C.2.4) to record the time required for the balloon to reach the end point of the prescribed pressure relief.
C.4 Test report
The test report should include the following information.
a) identification of the catheter;
b) the maximum, minimum, mean, and standard deviation of the balloon decompression time, expressed in seconds;
c) the definition given to the end point of pressure relief;
d) liquid used for filling;
e) Any anomalies observed.
Note. Units of measurement other than those specified in this section may be used in addition.
Appendix D
(Normative appendix)
Experiment on the relationship between balloon diameter and filling pressure
D.1 Principle
The purpose of this test is to determine the relationship between balloon diameter and filling pressure.
D.2 Instrument
D.2.1 Recommended guidewire or equivalent.
D.2.2 Water bath, control at (37 ± 2) ℃.
D.2.3 Fill liquid, such as room temperature water.
D.2.4 F...