YY/T 0450.3-2016 English PDF (YYT0450.3-2016)

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YY/T 0450.3-2016: Accessory devices for sterile single-use intravascular catheters - Part 3: Inflation devices for balloon of balloon dilatation catheters
YY/T 0450.3-2016
Accessory devices for sterile single-use intravascular catheters--Part 3. Inflation devices for balloon of balloon dilatation catheters
ICS 11.120.30
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0450.3-2007
Single-use sterile intravascular catheter accessories
Part 3. Balloon inflation device for balloon dilatation catheter
Part 3. Inflationdevicesforbaloonofbaloondilatationcatheters
Released on.2016-07-29
2017-06-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 structure type 1
4 pointer pressure gauge 1
4.1 Unit of measurement 1
4.2 Zero 2
4.3 division 2
4.4 Negative pressure indication 2
4.5 Basic error 2
4.6 Hysteresis 2
4.7 Smoothness of pointer deflection 2
4.8 tapping displacement 2
5 digital pressure gauge 2
5.1 Unit of measure 2
5.2 Zero drift 2
5.3 indication resolution 2
5.4 Negative pressure indication 2
5.5 Basic error 3
5.6 Repeatability 3
5.7 Hysteresis 3
5.8 Stability 3
5.9 indication fluctuation 3
5.10 Security Requirements 3
6 Pressure device performance 3
6.1 Positive pressure tightness 3
6.2 Pressure release 3
6.3 Negative pressure retention 3
6.4 Pressure decay 3
6.5 Operation reliability of the release device 3
6.6 Direction of rotation 4
6.7 Connector 4
6.8 Bubble observation and elimination 4
6.9 Extension tube size 4
6.10 Capacity Scale 4
6.11 Capacity tolerance 4
7 Chemical properties 4
8 Biological properties 4
8.1 Sterile 4
8.2 Biocompatibility 4
9 logo 4
10 Packing 5
Appendix A (Normative Appendix) Pointer Pressure Gauge Performance Test Method 6
A.1 Test conditions 6
A.2 Test equipment 6
A.3 Inspection point 6
A.4 Test Method 6
A.5 Basic error test 6
A.6 Hysteresis test 6
A.7 Pointer deflection stability test 7
A.8 tapping displacement test 7
Appendix B (normative appendix) Digital pressure gauge performance test method 8
B.1 Test conditions 8
B.2 Test equipment 8
B.3 Inspection point 8
B.4 Test Method 8
B.5 Zero drift test 8
B.6 Basic error test 8
B.7 Repeatability test 9
B.8 Hysteresis test 9
B.9 Stability test 9
B.10 indication fluctuation test 9
Appendix C (Normative Appendix) Pressure Tester Performance Test 10
C.1 Test conditions 10
C.2 Pressure release test 10
C.3 Negative pressure retention test 10
C.4 Pressure decay test 10
C.5 capacity tolerance 10
Appendix D (informative) Example 12 of the unit of measure provided by the manufacturer to the user
Reference 13
Foreword
YY/T 0450, "Single-Use Sterile Endovascular Catheter Accessory" consists of the following.
--- Part 1. Guided devices;
--- Part 2. trocar peripheral catheter plug;
--- Part 3. Balloon inflation device for balloon dilatation catheters.
This part is the third part of YY/T 0450.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0450.3-2007, compared with YY 0450.3-2007, except for editorial changes, the main technical changes are as follows.
--- Increased the structural form of the product, including a balloon inflation device for balloon dilatation catheters with digital pressure gauges;
--- Removed the marking requirements of the product;
--- Increased the requirements and test methods for digital pressure gauges;
--- Modify "compliance" to "pressure decay" and modify its requirements and test methods.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is under the jurisdiction of Jinan Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
This section drafted by. Shandong Hengxin Testing Technology Development Center, Medtronic (Shanghai) Management Co., Ltd., Shenzhen Yixinda Medical New
Technology Co., Ltd., Shandong Province Medical Device Product Quality Inspection Center.
The main drafters of this section. Bai Bing, Chen Huimin, Tang Jie, Wan Min.
The previous versions of the standards replaced by this section are.
---YY 0450.3-2007.
Single-use sterile intravascular catheter accessories
Part 3. Balloon inflation device for balloon dilatation catheter
1 Scope
This part of YY/T 0450 specifies a one-time manual filling device for intravascular balloon dilatation catheters (referred to as "filling device"
According to the requirements of the "), the product is suitable for the balloon compression of the balloon dilatation catheter specified in YY 0285.4, so that it expands to achieve expansion
The purpose of the blood vessel or the release of the stent.
The device for releasing the endovascular embolization device and the pressure device for the balloon blocking catheter have a knot similar to that of the charging device specified in this section.
Structure. This standard does not apply to these devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.2 Syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
GB 9706 medical electrical equipment (all parts)
GB 15810 single use sterile syringe
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB/T 19633.1-2015 Packaging of terminally sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging systems
Claim
YY 0505 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standards. Electromagnetic Compatibility Requirements and Testing
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1 . Requirements for terminally sterilized medical devices
3 structure type
The charging device is mainly composed of a bolus system, a pressure gauge and a connecting pipe. The pressure gauge is divided into two types. a pointer pressure gauge and a digital pressure gauge.
Type.
4 pointer pressure gauge
4.1 Unit of measurement
The pressure gauge should be expressed in both units of measurement atm1)/MPa or atm/psi1). The atm scale is marked on the outer ring, MPa or psi
The mark is in the inner circle.
1) Both atm and psi are non-international unit units. 1 atm = 101325 Pa, 1 psi = 6894.76 Pa. YY 0285.4/ISO 10554-4 requires
The kPa indicates the filling pressure of the airbag and allows for the attachment of other non-international unit units. Due to the size of the pressure gauge, the surface of a pressure gauge
Up to two scales can be given. It is recommended that the manufacturer provide the user with a pair that can intuitively reflect the three unit systems (atm, psi and Pa).
A diagram (see Appendix D) or a table should be used to facilitate checking.
4.2 Zero point
The zero scale line of the pressure gauge should be between two scales, the positive pressure part from zero to the right (clockwise); the vacuum part from zero to the left (reverse time)
needle).
4.3 division
The minimum graduation value of the MPa scale shall be 0.1 MPa, and the numerical interval shall not exceed 0.5 MPa; the minimum division value of the atm scale shall be
1atm, the number interval should not exceed 5atm; the minimum division value of the psi scale should not exceed 50psi and the number interval should not exceed
100psi.
4.4 Negative pressure indication
The negative pressure region of the pressure gauge may have no index, but should give a range indicating negative pressure (such as a sector) and marked with "VAC" or "true"
Empty".
Note. In clinical use, in order to facilitate the removal of the expanded catheter, it is required to apply a negative pressure to the balloon.
4.5 Basic error
When tested in accordance with A.5, the basic error of the pressure gauge is expressed by the reference error (in % of range), over 90% of the measurement range.
The basic error limit is ±4.0%, and the basic error limit for the remaining measurement range is ±3.0%.
Note. The accuracy level of the meter is indicated by the basic error limit of “except for the remainder of the measurement range above 90%”.
4.6 Hysteresis
When tested in accordance with A.6, the hysteresis of the gauge shall not be greater than the absolute value of the basic error limit.
4.7 Smoothness of pointer deflection
When tested in accordance with A.7, the pointer of the meter shall not be pulsating or stagnant during the measurement.
4.8 tapping displacement
When testing according to A.8, when tapping with a finger (so that the pointer can swing freely) at any position within the measuring range, the pointer refers to
The variation of the indication value shall not be greater than 1/2 of the absolute value of the basic error limit.
5 digital pressure gauge
5.1 Unit of measurement
The pressure gauge should be expressed in at least two units of measurement atm/MPa or atm/psi.
5.2 zero drift
When tested according to B.5, the zero drift of the pressure gauge shall not exceed 1/2 of the absolute value of the basic error limit within 1 h.
5.3 indication resolution
The indication value in MPa shall be able to increase or decrease the pressure by no more than 0.1 MPa; the indication value in atm shall be no more than 1 atm.
Increase or decrease pressure; the indication in psi should be able to increase or decrease pressure by no more than 50 psi.
5.4 Negative pressure indication
The pressure gauge should indicate the negative pressure and be marked with a "-" or other equivalent type to clearly distinguish the positive pressure.
Note. In clinical use, in order to facilitate the removal of the expanded catheter, it is required to apply a negative pressure to the balloon.
5.5 Basic error
When tested according to B.6, the basic error of the pressure gauge is expressed by the reference error (in % of the range), which is more than 90% of the measurement range.
The basic error limit is ±4.0%, and the basic error limit for the remaining measurement range is ±3.0%.
Note. The accuracy level of the meter is indicated by the basic error limit of “except for the remainder of the measurement range above 90%”.
5.6 repeatability
When tested in accordance with B.7, the repeatability of the pressure gauge shall not be greater than the absolute value of the basic error limit.
5.7 Hysteresis
When tested according to B.8, the hysteresis of the pressure gauge shall not exceed the absolute value of the basic error limit.
5.8 Stability
When tested in accordance with B.9, the stability of the pressure gauge shall not be greater than the absolute value of the basic error limit.
5.9 indication fluctuation
When tested according to B.10, the fluctuation of the indication of the pressure gauge shall not exceed 1/3 of the absolute value of the basic error limit.
5.10 Safety requirements
5.10.1 Digital pressure gauge electrical safety shall comply with the requirements of GB 9706.
5.10.2 Digital pressure gauge electromagnetic compatibility shall comply with the requirements of YY 0505.
6 Pressure device performance
6.1 Positive pressure tightness
Pointer pressure gauges In all test procedures specified in Appendix A, the pressure-filling devices (including connecting pipes and joints) shall not be visually observed.
Leakage; digital pressure gauges In all test procedures specified in Appendix B, the charging devices (including connecting pipes and joints) should not be visually observed.
Leakage.
6.2 Pressure release
6.2.1 Pressure-filling device with pointer pressure gauge When tested in accordance with C.2, the pointer of the pressure gauge should be able to return to its original position quickly.
Note. The position of the filling device with the pointer pressure gauge can be regarded as “return to the original position” if it meets the requirements of 4.6.
6.2.2 Pressure-filling device with digital pressure gauge When tested in accordance with C.2, the pressure gauge should be able to return to its original position quickly.
Note. A charging device with a digital pressure gauge is considered to be “back to home” in accordance with the requirements of 5.7.
6.3 Negative pressure retention
When tested according to C.3, the charging device should be able to maintain a vacuum for 10 min.
6.4 Pressure decay
When tested according to C.4, the pressure loss of the charging device at the upper limit of the measuring range shall not exceed 10%.
6.5 Operation reliability of the release device
The release device of the charging device should enable the pressure pusher to switch between linear motion and rotational motion. Its reliability should be able to meet
The tests specified in Record A, Appendix B and Appendix C proceed normally.
6.6 Direction of rotation
The thread of the core of the charging device should be designed with a right thread, that is, when the operator turns the screw to the right when facing the surface in normal use mode,
The pressure rises and the pressure drops as the screw is turned to the left.
6.7 connector
The connecting pipe of the charging device shall have an outer conical locking joint conforming to GB/T 1962.2.
Note. In order to meet the test requirements specified in this part of YY/T 0450, the sealing requirements for the outer conical joint on the connecting pipe are much higher than those of GB/T 1962.2.
Claim.
6.8 Bubble observation and elimination
The design and materials used for the charging device should facilitate the observation and removal of internal air.
6.9 Extension tube size
The length of the extension tube of the filling device (including the joint connected to the balloon dilatation catheter) should be not less than 250 mm.
6.10 capacity scale
The filling device should have a scale indicating the volume of liquid injected into the balloon dilatation catheter. The scale should meet the following requirements.
a) Indexing should be done in milliliters. The minimum division valu...