YY/T 0450.3-2016 English PDF (YY/T0450.3-2016)

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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
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.30
C 31
Replacing YY 0450.3-2007
Accessory devices for sterile single-use intravascular
catheters - Part 3: Inflation devices for balloon of balloon
dilatation catheters
压装置
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Structure type ... 6
4 Pointer pressure gauge ... 6
4.1 Unit of measurement ... 6
4.2 Zero point ... 6
4.3 Graduation ... 6
4.4 Negative pressure indication ... 6
4.5 Basic error ... 7
4.6 Hysteresis ... 7
4.7 Stability of pointer deflection ... 7
4.8 Tap displacement ... 7
5 Digital pressure gauge ... 7
5.1 Unit of measurement ... 7
5.2 Zero drift ... 7
5.3 Indication resolution ... 7
5.4 Negative pressure indication ... 8
5.5 Basic error ... 8
5.6 Repeatability ... 8
5.7 Hysteresis ... 8
5.8 Stability ... 8
5.9 Indication fluctuation ... 8
5.10 Safety requirements ... 9
6 Performance of the inflation device... 9
6.1 Positive pressure tightness ... 9
6.2 Pressure relief ... 9
6.3 Negative pressure retention ... 9
6.4 Pressure decay ... 9
6.5 Operating reliability of the release device ... 10
6.6 Direction of rotation ... 10
6.7 Joints ... 10
6.8 Observation and removal of air bubbles ... 10
6.9 Extension tube size ... 10
6.10 Capacity scale ... 10
6.11 Capacity tolerance ... 11
7 Chemical properties ... 11
8 Biological properties ... 11
8.1 Sterility... 11
8.2 Biocompatibility ... 11
9 Marks ... 11
10 Packaging ... 12
Annex A (normative) Test methods for performance of pointer pressure gauges ... 13
A.1 Test conditions ... 13
A.2 Test instruments ... 13
A.3 Inspection points ... 13
A.4 Test method ... 13
A.5 Basic error test ... 13
A.6 Hysteresis test ... 14
A.7 Pointer deflection stability test ... 14
A.8 Tapping displacement test ... 14
Annex B (normative) Test methods for performance of digital pressure gauges ... 15
B.1 Test conditions ... 15
B.2 Test instruments ... 15
B.3 Inspection points ... 15
B.4 Test method ... 15
B.5 Zero point drift test ... 16
B.6 Basic error test ... 16
B.7 Repeatability test ... 16
B.8 Hysteresis test ... 16
B.9 Stability test ... 16
B.10 Indication fluctuation test ... 17
Annex C (normative) Performance test of inflation device ... 18
C.1 Test conditions ... 18
C.2 Pressure release test ... 18
C.3 Negative pressure retention test ... 18
C.4 Pressure decay test ... 19
C.5 Capacity tolerance ... 19
Annex D (informative) An example of the measurement unit comparison chart provided
by the manufacturer to the user ... 20
Bibliography ... 21
Accessory devices for sterile single-use intravascular
catheters - Part 3: Inflation devices for balloon of balloon
dilatation catheters
1 Scope
This Part of YY/T 0450 specifies the requirements for the single-use intravascular
manual inflation devices for balloon dilatation catheters (referred to as "inflation
devices"). This product is suitable for balloon compression of balloon dilatation
catheters specified in YY 0285.4, making it expand to achieve the purpose of dilating
blood vessels or releasing stents.
The release device of intravascular embolism and the inflation device of the balloon
occlusion catheter have a similar structure to the inflation device specified in this Part.
This standard does not apply to these devices.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) 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 9706 (all parts), Medical electrical equipment
GB 15810, Sterile syringes for single use
GB/T 16886.1, Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process
GB/T 19633.1-2015, Packaging for terminally sterilized medical devices -- Part 1:
Requirements for materials, sterile barrier systems and packaging systems
YY 0505, Medical electrical equipment -- Part 1-2: General requirements for safety
-- Collateral standard: Electromagnetic compatibility. Requirements and tests
YY/T 0615.1, Requirements for medical devices to be designated “STERILE” --
Part 1: Requirements for terminally sterilized medical devices
3 Structure type
The inflation device is mainly composed of a push injection system, pressure gauges
and connecting pipeline. Pressure gauges are divided into two types: pointer pressure
gauges and digital pressure gauges.
4 Pointer pressure gauge
4.1 Unit of measurement
The pressure gauge shall be expressed in atm1/MPa or atm/psi1 at the same time. The
atm scale is marked on the outer ring. The MPa or psi unit is marked on the inner ring.
4.2 Zero point
The zero scale line of the pressure gauge shall be between the two scales. The positive
pressure part is from zero to right (clockwise). The vacuum part is from zero to left
(counterclockwise).
4.3 Graduation
The minimum division value of the MPa scale shall be 0.1 MPa. The number interval
shall not exceed 0.5 MPa. The minimum division value of the atm scale shall be 1 atm.
The interval between numbers shall not exceed 5 atm. The minimum division value of
the psi scale shall not exceed 50 psi. The number interval shall not exceed 100 psi.
4.4 Negative pressure indication
The negative pressure area of the pressure gauge may not have graduations. However,
a negative pressure range (such as a fan-shaped area) shall be given and marked with
"VAC" or "vacuum".
NOTE: In clinical use, to facilitate the removal of the expanded catheter, it is required to apply
negative pressure to the balloon.
1 Both atm and psi are non-SI units. 1 atm = 101325 Pa, 1 psi = 6894.76 Pa. YY 0285.4/ISO10554-4 requires the
inflation pressure of the airbag to be marked in kPa, and it is allowed to add other non-SI units. Due to the size
limitation of the pressure gauge, only two scales of measurement units can be given on the surface of a pressure
gauge. It is recommended that the manufacturer provide the user with a diagram (see Annex D) or table that can
intuitively reflect the correspondence between the three unit systems (atm, psi and Pa) for easy checking.
4.5 Basic error
When tested according to A.5, the basic error of the pressure gauge is expressed by
reference error (in % of range). The basic error limit of the part above 90% of the
measuring range is ±4.0%. The basic error limit for the rest of the measurement range
is ±3.0%.
NOTE: The accuracy level of the instrument is expressed by the basic error limit of "the rest of the
measurement range except for the part above 90%”.
4.6 Hysteresis
When tested according to A.6, the hysteresis of the indication value of the pressure
gauge shall not be greater than the absolute value of the basic error limit.
4.7 Stability of pointer deflection
When tested according to A.7, during the measurement process, the pointer of the
instrument shall not jump or stagnate.
4.8 Tap displacement
During the test according to A.8, at any position within the measurement range, when
the instrument case is lightly tapped (so that the pointer can swing freely) with a finger,
the variation of the pointer 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 shall at least use two sets of measurement units: atm/MPa or atm/psi.
5.2 Zero drift
When tested according to B.5, the zero point drift of the pressure gauge shall not be
greater than 1/2 of the absolute value of the basic error limit within 1 h.
5.3 Indication resolution
The indicated value in MPa shall be able to increase or decrease the pressure by no
5.10 Safety requirements
5.10.1 The electrical safety of the digital pressure gauge shall meet the requirements of
GB 9706.
5.10.2 The electromagnetic compatibility of digital pressure gauges shall meet the
requirements of YY 0505.
6 Performance of the inflation device
6.1 Positive pressure tightness
During all the tests specified in Annex A of the pointer pressure gauge, the inflation
device (including connecting pipes and joints) shall not have visually observed leakage.
During all the test procedures specified in Annex B, the inflation device of the digital
pressure gauge (including connecting pipes and joints) shall not have visually observed
leakage.
6.2 Pressure relief
6.2.1 When the inflation device with a pointer pressure gauge is tested according to C.2,
the pointer of the pressure gauge shall be able to quickly return to its original position.
NOTE: The return of the pointer of the inflation device with a pointer pressure gauge can be
considered as "returning to the original position" if it meets the requirements of 4.6.
6.2.2 When the inflation device with a digital pressure gauge is tested according to C.2,
the pressure gauge shall be able to quickly return to its original position.
NOTE: The inflation device with a digital pressure gauge that complies with the requirements of
5.7 can be considered "returning to its original position".
6.3 Negative pressure retention
When tested according to C.3, the inflation device shall be able to maintain a vacuum
state for 10 min.
6.4 Pressure decay
When tested according to C.4, the pressure loss of the inflation device at the upper limit
of the measurement range shall not exceed 10%.
6.5 Operating reliability of the release device
The release device of the inflation device shall be able to convert the pressure push rod
between linear motion and rotary motion. Its reliability shall be able to meet the normal
requirements of the tests specified in Annex A, Annex B and Annex C.
6.6 Direction of rotation
The thread of the core rod of the inflation device shall be designed with right-hand
thread. That is, with the operator facing the surface in normal use, the pressure increases
when the screw is turned to the right and decreases when the screw is turned to the left.
6.7 Joints
The connecting pipe of the inflation device shall have an outer cone locking joint that
complies with 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 external conical joints on the connecting pipes are much higher than the
requirements of GB/T 1962.2.
6.8 Observation and removal of air bubbles
The design and materials used for the inflation device shall be easy to observe and
remove the air inside.
6.9 Extension tube size
The length of the extension tube of the inflation device (including the joint connected
with the balloon dilation catheter) shall not be less than 250 mm.
6.10 Capacity scale
The inflation device shall have a scale indicating the volume of fluid injected into the
balloon dilation catheter. The scale shall meet the following requirements:
a) Graduation shall be done in milliliters. The minimum division value shall not
exceed 2 mL. Numbers shall be separated by no more than 5 mL.
b) When used in a normal manner according to the instruction manual, the
measurement figures shall face the operator in an upright manner.
Annex A
(normative)
Test methods for performance of pointer pressure gauges
WARNING: The test is carried out under high pressure conditions. The test shall
be carried out under the protection conditions to ensure safety.
A.1 Test conditions
The test uses the following conditions:
a) Ambient temperature: (20±5)℃.
b) The pressure gauge is in the normal working position, or the inflation device is in
the normal working position.
c) Uniform load variation.
d) Test medium: water.
A.2 Test instruments
The standard pressure gauge used for the test shall not be greater than grade 1.0. The
measurement display range does not exceed three-quarters of its range.
A.3 Inspection points
Take the digital scale line marked with atm or MPa as the inspection point.
A.4 Test method
The test is carried out by comparing the instrument under test with the standard
instrument. That is, connect the water-filled inflation device to a standard gauge through
a specific tee. Pressurize according to the manufacturer's instructions for use.
A.5 Basic error test
A.5.1 Increase the load uniformly and slowly from zero during the test. Test each
specified inspection point to the upper limit of the measurement range. Maintain 3 min.
Then reduce the load evenly and slowly to zero. Inspect each inspection point.
Annex B
(normative)
Test methods for performance of digital pressure gauges
WARNING: The test is carried out under high pressure conditions. The test shall
be carried out under the protection conditions to ensure safety.
B.1 Test conditions
The test uses the following conditions:
a) Ambient temperature: (20±5)℃.
b) The pressure gauge is in the normal working position, or the inflation device is in
the normal working position.
c) Uniform load variation.
d) Test medium: water.
B.2 Test instruments
The standard pressure gauge used for the test shall not be greater than grade 1.0. The
measurement display range does not exceed three-quarters of its range.
B.3 Inspection points
The inspection points shall be evenly distributed within the measuring range of the
instrument. It shall be at least 10 points (including the upper and lower limit points of
the measurement range).
B.4 Test method
The test is carried out by comparing the instrument under test with the standard
instrument. That is, connect the water-filled inflation device to a standard gauge through ...