YY/T 0450.3-2016Accessory devices for sterile single-use intravascular catheters - Part 3: Inflation devices for balloon of balloon dilatation catheters (English PDF)

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/ISO 10554-4 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.

5.1 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.

6.1 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

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.

A.1 Test conditions

The test uses the following conditions:

a) Ambient temperature: (20±5)°C.

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.

B.1 Test conditions

The test uses the following conditions:

a) Ambient temperature: (20±5)°C.

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 a specific three-way device. Before each test, the instrument with a zero-adjustment device shall adjust the initial indication to zero. Pressurize according to the manufacturer's instructions for use.

B.5 Zero point drift test

When adjusting the inflation device to the standard pressure indication value of zero, record the initial indication value (if there is a zero adjustment device, the initial indication value can be adjusted to zero). Then, record an indication every 15 min until 1 h. The value with the largest absolute value among the differences between each indicated value and the initial indicated value, expressed as a percentage of the range, is the zero point drift of the digital pressure gauge. The result shall comply with the provisions of 5.2.

B.6 Basic error test

B.6.1 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.

B.6.2 The basic error shall be in the positive and negative travel. Investigate whether the difference between the indicated value and the indicated value of the inspection point meets the requirements of 5.5.

B.6.3 According to the above method, three consecutive inspections are carried out.

The basic error of indication value for each test shall comply with the provisions of 5.5.

B.7 Repeatability test

In the three inspections of B.6.3, compare the indication values of the same stroke at each inspection point. Take the difference with the largest absolute value. The result shall comply with the provisions of 5.6.

B.8 Hysteresis test

In the inspection of B.6.1, compare the indication values of forward and reverse strokes at each test point. Take the largest difference. The result shall comply with the provisions of 5.7.

B.9 Stability test

Inspect according to B.6.1. Record the positive and negative stroke indication value of each inspection point. Calculate its average value. Then, pressurize to 30%~70% of the upper limit of the measurement range and keep it for 48 h. Then repeat the inspection of B.6.1. Record the positive and negative stroke indications of each inspection point again and calculate the average value. Compare the two averages for each test point.

Take the absolute difference. Calculate the stability of each inspection point according

C.1 Test conditions

Same as A.1.

NOTE: The performance test of the inflation device shall be carried out after the test in Annex A is completed. Refer to the manufacturer's instruction manual.

C.2 Pressure release test

According to the manufacturer's instruction manual, pressurize the inflation device to 3/4 of the full scale with the test medium [A.1d)], operate the release device. Observe whether the pointer or indication can return to its original position.

C.3 Negative pressure retention test

C.3.1 Steps

After the test in C.2, for pointer pressure gauges, turn the handle of the inflation device.

Adjust the pointer to the vacuum indication area for 10 min. Observe the pointer. Operate the release device again.

After the test in C.2, for digital pressure gauges, turn the handle of the inflation device.

Adjust the display value to negative pressure value. Maintain 10 min. Observe the indicated value. Operate the release device again.

C.3.2 Result presentation

For the pointer pressure gauge, if the pointer does not return to the zero line within the holding time before operating the release device, but the pointer can return to the zero line after the release, it meets the requirements.

For digital pressure gauges, if the indication value does not return to zero within the holding time before operating the release device, but the indication value can return to zero after the release, it meets the requirements.