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GB/T 15812-1995 (GB/T15812-1995)

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GB/T 15812-1995: PDF in English (GBT 15812-1995)

GB/T 15812-1995
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 48
Flexible Polymeric Tubes for Medical Use -
Physical Performance Test Method
[Replaced by GB/T 15812.1-2005]
ISSUED ON: DECEMBER 8, 1995
IMPLEMENTED ON: AUGUST 1, 1996
Issued by: State Technical Supervision Bureau
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 General Requirements of Tests ... 4 
3 Bending Resistance Test... 4 
4 Compressive Deformation Test ... 6 
5 Hydraulic Pressure Resistance Test ... 7 
6 Negative Pressure Resistance Test ... 8 
7 Nozzle Crack Resistance Test ... 9 
8 Chemical Liquid Resistance Test ... 11 
9 Steam Sterilization Resistance Test ... 13 
10 Test Report ... 14 
Flexible Polymeric Tubes for Medical Use -
Physical Performance Test Method
1 Scope
This Standard specifies the test methods for the bending resistance, compressive
deformation resistance, hydraulic pressure resistance, negative pressure resistance,
nozzle crack resistance, chemical liquid resistance and steam sterilization resistance
performance of flexible polymeric tubes for medical use.
This Standard is mainly applicable to the physical performance test of flexible
polymeric tubes for medical use, whose sectional dimensions remain unchanged and
manifest drapability within the length range (hereinafter referred to as “flexible tube”).
If applicable, other flexible tubes for medical use may also take this as a reference.
2 General Requirements of Tests
2.1 Unless it is otherwise stipulated, test environment shall be: temperature 18 ~ 28 °C;
relative humidity 40% ~ 70%. Some tests may be stipulated to be conducted under
simulated service environment of flexible tube, for example, water or normal saline at
37 °C ± 1 °C.
2.2 The time interval from the manufacture to the test of flexible tube shall be not less
than 24 h.
2.3 Before test, flexible tube shall be placed under test environment for at least 3 h.
After sample preparation, the sample shall be placed under test environment for at
least 30 min.
2.4 In terms of sample preparation, 3 samples shall be prepared from unit products for
parallel test. If it is restricted by the length of products, prepare as many samples as
possible.
2.5 The external diameter of flexible tube shall be represented as D. Measurement
shall be conducted through universal or exclusive measuring tools; reading shall be
accurate to 0.02 mm. The arithmetic mean value of values measured from three points
shall be taken: the middle part and both sides of the sample.
3 Bending Resistance Test
3.1 Objective
4 Compressive Deformation Test
4.1 Objective
Certain flexible tubes have certain requirements towards radial flexibility. The objective
of this test is to evaluate the radial flexibility of flexible tube or a certain section of
flexible tube.
4.2 Principle
After flexible tube receives the stipulated compressive force, the variation rate of the
flexible tube’s radial dimension before and during the reception of such force shall be
taken to represent compressive deformation rate; the variation rate of the flexible
tube’s radial dimension before and after the reception of such force shall be taken to
represent permanent compressive deformation rate.
4.3 Test Device
Compression test machine or tensile test machine (equipped with commutator); the
load on the flexible tube being tested shall be 15% ~ 85% of full load of the test machine;
the division value of displacement meter shall be 0.01 mm. The dimension of the
compression plate shall be more than the length of the flexible tube sample being
tested.
4.4 Sample
Sample length shall be 4 D.
4.5 Test Procedure
4.5.1 Flatly place sample in the middle of the lower compression plate of the tensile
test machine and compression test machine; adjust the upper compression plate.
When the upper compression plate contacts the flexible tube, record the reading on
the displacement meter E0.
4.5.2 Initiate the test machine; at the traction speed of 50 mm/min ± 5 mm/min,
compress the flexible tube. When it reaches the stipulated load, stop the machine, then,
record the reading on the displacement meter E1. Maintain this load for certain time
(comply with the stipulations in product standards).
4.5.3 Let the tensile test machine and compression test machine reversely operate at
the previous speed, till the load reaches zero, then, immediately stop the machine.
Record the reading on the displacement meter E2.
4.6 Test Result
Test result shall be represented through the compressive deformation rate and the
the machine. Maintain the pressure to the time stipulated by product standards. If the
flexible tube explodes, record the pressure value when it explodes.
5.6 Test Result
5.6.1 Whether the flexible tube explodes and the pressure value when it explodes shall
be reported.
5.6.2 During the test, due to the stripping of the flexible tube’s plug or connector, and
leakage at the junction of the plug or the connector, explosion within the range of D
from the plug or the connector shall be invalid. The test shall be re-conducted.
6 Negative Pressure Resistance Test
6.1 Objective
Certain flexible tubes which are used for traction, for example, negative pressure
drainage tube, would bear certain negative pressure during the usage. The objective
of this test is to evaluate the negative pressure resistance performance of this type of
flexible tubes.
6.2 Principle
After draining flexible tube to the stipulated negative pressure, determine whether the
flexible tube is qualified by whether a steel ball of stipulated diameter rolls in the tube
cavity.
6.3 Test Device
6.3.1 Vacuum gauge; the stipulated negative pressure value shall be within 15% ~ 85%
of full range; division value: Level-1.0.
6.3.2 Vacuum pump.
6.3.3 Steel ball, whose diameter shall be calculated in accordance with Formula (3):
Where,
---diameter of steel ball, expressed in mm;
k---coefficient, 0.5 ~ 0.9 (stipulated in product standards);
d---internal diameter of flexible tube for testing, expressed in mm.
6.4 Sample
Unit product.
6.5 Test Procedure
6.5.1 Stuff one end of the flexible tube sample, which is flatly placed, with a plug. Thus,
it becomes a free end. Stuff the other end with steel ball. Then, connect it with the
vacuum pump and the vacuum gauge through tube connector.
6.5.2 Initiate the vacuum pump. When the vacuum gauge’s pointer points to the
stipulated negative pressure, stop the pump, then, maintain for 1 min. During this
period of time, tilt the flexible tube to inspect whether the steel ball rolls.
6.6 Test Result
If the steel ball rolls in the tube cavity, then, the flexible tube shall be deemed as
qualified, otherwise, it shall be deemed as unqualified.
7 Nozzle Crack Resistance Test
7.1 Objective
Certain flexible tubes are often connected with a connector in usage, for example,
intubation tube for medical use. Thus, the nozzle shall have certain requirements
towards crack resistance. The objective of this test is to evaluate the nozzle crack
resistance of flexible tube.
7.2 Principle
Cut a standard incision on the nozzle sample of flexible tube; use a cone (conical
degree: 1:5) to stretch the sample to the stipulated dimension. Then, inspect whether
the sample cracks in the axial direction.
7.3 Test Device
7.3.1 Test the steel cone. As it is stipulated in Figure 2, on the cross section, there is a
marking (spacing: 1 mm) along the axial direction, which signifies that the minimum
division value in the radial direction is 0.2 mm; there is a large marking in every 5 small
markings, which signifies that the division value in the radial direction is 1 mm.
Markings are merely allowed to have lower concave, not upper convex.
Figure 2
If the sample can reach the stipulated diameter and does not completely crack, it shall
be deemed as qualified, otherwise, it shall be deemed as unqualified.
8 Chemical Liquid Resistance Test
8.1 Objective
Certain flexible tubes might be immersed in chemicals for sterilization during the usage,
for example, 75% ethanol. This test aims at evaluating the variation of the physical
performance of flexible tubes after the effect of chemical liquid.
Generally speaking, various pharmaceutical liquids that people use for the function of
diagnosis and treatment are not corrosive to flexible tubes. If it is firmly believed that
certain pharmaceutical liquids that are exposed to flexible tubes during the usage might
be corrosive to flexible tubes, the influence of these pharmaceutical liquids on the
physical performance of flexible tubes shall be evaluated.
NOTE: the toxic and side effect of flexible tube materials on pharmaceutical liquids shall
be evaluated in accordance with relevant biological test methods.
8.2 Principle
Under the circumstance of having absolutely no external influence on the flexible tube,
immerse the flexible tube in chemical liquid within the stipulated time. Take a sample
that is not immersed as a contrast; test the physical performance. The reduction rate
of the physical performance, the qualification of the physical performance or the
inspection of appearance variation signifies the chemical liquid resistance of flexible
tubes.
NOTE: the physical performance is not restricted to items included in this Standard.
8.3 Test Device
8.3.1 Test solution: select liquid that flexible tubes might contact as the test solution.
8.3.2 Beaker: in an appropriate size and equipped with surface utensil (seal, if
necessary).
8.3.3 Test devices used in the performance test methods in Chapter 3 ~ Chapter 7.
8.4 Sample
Same as the samples stipulated in the performance test methods in Chapter 3 ~
Chapter 7.
8.5 Test Procedure
8.5.1 Place the sample in the beaker; completely immerse it in the test solution. When
the density of the test solution is more than the density of the sample, appropriate
methods would be needed to completely immerse the sample in the test solution.
8.5.2 The time of immersion shall comply with the stipulation in product standards. In
accordance with the practical service condition of flexible tubes, 1 h, 2 h, 4 h, 8 h, 16
h and 24 h, or 2 days, 3 days, 4 days and 7 days may be chosen.
8.5.3 When the time of immersion ends, take the sample out of the test solution. Firstly,
use liquid that has no influence on the sample, and can be mixed and dissolved with
the test solution to rinse the sample. Then, use filter paper or absorbent gauze to wipe
it. If the test solution is volatile under room temperature, for example, ethanol, then, it
is unnecessary to rinse or wipe the sample.
8.5.4 Within 30 min after wiping the sample, immediately conduct the tests in
accordance with the selected test items and the test methods stipulated in Chapter 3
~ Chapter 7.
8.6 Test Result
Test result may be expressed in the following three methods:
8.6.1 Take the determination result before and after the effect, calculate the reduction
rate of the physical performance in accordance with Formula (4). The result may be
deemed as the test result.
Where,
K1---physical performance value of the flexible tube before the effect;
K2---physical performance value of the flexible tube after the effect.
8.6.2 Take whether the flexible tube after the effect complies with the stipulated
physical performance as the test result.
8.6.3 Take the sample without the effect as the contrast; evaluate the flexible tube
through the colors, transparency, glossiness, cracks, crack extension, bubbles, small
pits, and the extension, stickiness, layering and warping of other similar defects, or
other deformation and partial dissolution, etc. Use the symbols stipulated in Table 1 to
represent the degree of appearance variation.
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.