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YY/T 0681.12-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.20
CCS C 31
Replacing YY/T 0681.12-2014
Test methods for sterile medical device package - Part 12:
Flex durability of flexible barrier materials
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 8
4 Overview of test methods ... 8
5 Application ... 9
6 Test instruments ... 9
7 Specimen preparation ... 11
8 Conditioning ... 11
9 Procedures ... 11
10 Report ... 12
Annex A (informative) Pinhole counting test ... 14
Annex B (informative) Gas and/or water vapor transmission rate test ... 16
Bibliography ... 17
Test methods for sterile medical device package - Part 12:
Flex durability of flexible barrier materials
1 Scope
This document describes test methods for the flex durability of flexible barrier materials.
This document applies to the testing of the flex durability of flexible barrier materials.
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 2918, Plastics - Standard atmospheres for conditioning and testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 pinhole
A small opening of no particular shape or size that passes completely through all layers
of a flexible barrier material.
3.2 flexible
Easy to fold, bend, twist by hand.
4 Overview of test methods
4.1 Unless otherwise specified, the flexing test is performed on specimens of flexible
barrier materials under standard atmospheric conditions. The flexing conditions, times
and flexing degree vary with the structure type of the specimen. The flexing action
consists of a twisting movement followed by a horizontal movement (in most cases).
Repeatedly twist and compress the specimen in this way. The frequency is 45 times/min.
4.2 The degree of damage to the structural and/or mechanical properties of the material
is judged by the flexing test. The properties to be evaluated in the flexing test determine
the appropriate level of test conditions. For flexible barrier film materials, the pinhole
counting test and gas and/or water vapor transmission rate test methods can be used,
see Annex A and Annex B. For the evaluation methods of breathable materials such as
paper and polyolefin nonwovens, please refer to standards such as GB/T 19633.1 or
YY/T 06981).
4.3 The various test conditions are summarized as follows:
a) Condition A: full flexing for 1h (that is, 2700 cycles);
b) Condition B: full flexing for 20mins (that is, 900 cycles);
c) Condition C: full flexing for 6mins (that is, 270 cycles);
d) Condition D: 20 cycles of full flexing;
e) Condition E: 20 cycles of partial flexing.
5 Application
5.1 The various conditions described in this test are to prevent the occurrence of too
many pinholes that are inconvenient to count and meaningless when testing a specimen
structure, and the occurrence of too few pinholes is also meaningless. Generally, the
number of pinholes on each sample shall be between 5~50. Material construction,
purpose of the test, and agreement between interested parties are important factors to
consider when selecting the level of test conditions.
5.2 This test method does not measure any part of wear associated with flux-to-break.
5.3 Failure of the integrity of one or more layers in a composite layer structure requires
a different test than the need to check for pinholes that penetrate completely through
the structure. Gas and/or water vapor transmission tests can be combined with the
flexing test to measure loss of layer integrity. However, any penetration test requiring a
differential pressure cannot measure the penetration coefficient in the presence of a
pinhole.
6 Test instruments
6.1 Flexing tester: is designed to be set up according to the specifications listed in
Chapter 9. The instrument shall mainly consist of a (90±1)mm diameter fixed shaft and
a (90±1)mm diameter moving shaft. When the moving shaft is at the initial position of
the stroke (that is, the maximum distance), the two shafts face to face are separated by
(180±2)mm. Both shafts shall have vents to protect the sample from pressure. The width
1) Test methods such as tensile strength and/or air permeability.
7 Specimen preparation
7.1 The samples are cut into sheets of 200mm × 280mm. The 200mm dimension is the
test direction. This is also the direction of the flexing tester shaft.
7.2 Four samples are flexed in each of their machine direction and cross direction. In
addition, four flexed samples are taken from positions adjacent to the samples in two
directions as control samples.
7.3 Leave open on both sides of the sample without sealing or taping it. Use a double-
sided pressure-sensitive adhesive tape with a width not exceeding 13mm to bond the
unsealed specimen into a cylindrical shape suitable for the shaft of the testing machine.
8 Conditioning
According to the provisions of GB/T 2918, the sample shall be conditioned for at least
24h under the conditions that the relative humidity is (50±5)% and the temperature is
(23±2)°C (unless otherwise specified between the supplier and the purchaser).
9 Procedures
9.1 Test environment
Unless otherwise specified, the flexing test is carried out under the conditions described
in Chapter 8.
9.2 Flexing conditions
9.2.1 Condition A
9.2.1.1 Setting of flexing tester
Set the flexing tester to maximum stroke. This setting gives the first 90mm of travel a
440° rotational movement. Then it is a 65mm horizontal linear motion. The frequency
is 45 cycles/min. With this setting, when the moving shaft is at the initial position, the
distance between the moving shaft and the end face of the fixed shaft is 180mm. When
the moving shaft moves to the shortest distance, the end face is 25mm away from the
fixed shaft.
9.2.1.2 Flexing test
Attach the flexible barrier samples that have been taped with double-sided pressure
sensitive tape to the two shafts of the flexing tester. Or directly fix the sample on the
testing machine. Turn on the flexing tester. Flex the sample for 1h at 45 cycles/min (that
is, a total of 2700 cycles).
9.2.2 Condition B
The test conditions are the same as Condition A. The samples are flexed for 20min at
45 cycles/min. (that is, a total of 900 cycles under full flexing and swirling action).
9.2.3 Condition C
The test conditions are the same as Condition A. The samples are flexed for 6min at 45
cycles/min. (that is, a total of 270 cycles under full flexing and swirling action).
9.2.4 Condition D
The test conditions are the same as Condition A. The samples are flexed for 20 times at
45 cycles/min. (that is, a total of 20 cycles under full flexing and swirling action).
9.2.5 Condition E
Set the flexing tester to the partial flexing described in 6.1. At this time, set the moving
shaft so that the moving shaft only moves 80mm of the 180mm distance (the maximum
distance between the two shafts or the initial position). Therefore, only about 90% of
the swivel travel is used, giving a swivel motion of 400°. Horizontal travel is not used.
The closest distance between the two shafts is 95mm. The partial flexing session at this
short stroke will knead 20 cycles at 45 cycles/min.
9.3 Determination of flexing test results
9.3.1 Remove the flexible barrier material sample from the flexing tester. Mark a
150mm x 200mm area in the center. 150mm is the axial dimension of the tester. For
samples after flex durability testing, whether for pinhole or layer integrity inspection,
samples shall be taken in this area.
9.3.2 Perform a test to measure the properties of the samples after the flexing test.
Continue to test the sample according to the relevant test method.
10 Report
10.1 The sample conditioning and test environment used.
10.2 Sample specifications (thickness/gram weight), structure (if appropriate).
10.3 Flexing test conditions.
10.4 Evaluation method of flex durability.
10.5 Test results.
Annex A
(informative)
Pinhole counting test
A.1 Test purpose
Whether the flexing test resulted in breakage is determined by measuring pinholes
formed in the structure. Pinholes are determined by staining the white background with
dyed turpentine through the pinholes.
In this test, the material is determined to be damaged only if the dyed turpentine
penetrates the through-holes of the physical structure. A composite ply structure in
which one layer remains intact will not be able to detect failure by the stained turpentine
test.
A.2 Instruments and reagents
Large paint brush: width is 50mm~150mm.
Absorbent paper: paper that is absorbent.
White paper: uncoated paper, at least the same size as the specimen.
Turpentine (dyed, anhydrous): add 5g of anhydrous calcium chloride and 1.0g of oil-
soluble red staining solution to 100mL of turpentine oil (chemically pure, with a
specific gravity of 0.860~0.875 at 15°C). Stopper the container. Shake well. Leave it
for at least 10h. Shake from time to time. Use dry filter paper to filter. Store in an airtight
bottle.
NOTE: Pay attention that the use of these materials requires appropriate protection to avoid hazards
due to skin contact, inhalation and flammability.
A.3 Test steps
A.3.1 Remove the flexible barrier sample from the flexing tester. Mark a
150mm×200mm area in the center of the white paper. The 150mm dimension is the
axial dimension of the tester.
A.3.2 Tape the sample to the white paper.
A.3.3 Brush the stained turpentine solution onto the sample. Repeat as needed. Leave
it for 1min.
A.3.4 After 1min, wipe off the dyed turpentine with absorbent paper. Apply pressure
Annex B
(informative)
Gas and/or water vapor transmission rate test
B.1 Test purpose
Whether the flexing test leads to breakage is determined by the change in the
transmission rate of the sample gas and/or water vapor.
Gas transmission rate means, at constant temperature and unit pressure, the volume of
gas that permeates a unit area of the specimen per unit time at steady transmission. It is
expressed by the volume value under standard temperature and pressure, in
cm3/(m2·24h·0.1MPa).
Water vapor transmission rate refers to the amount of water vapor permeated by a 1m2
specimen within 24h under the conditions of specified temperature, relative humidity,
certain water vapor pressure difference and certain thickness. The unit is: g/(m2·24h).
B.2 Instruments
Water vapor transmission rate tester, gas transmission rate tester.
B.3 Test methods
See GB/T 1037 and GB/T 26253 for the test method of water vapor transmission rate.
See GB/T 1038, GB/T 19789 and YY/T 1286.1 for the test method of gas transmission
rate.
B.4 Test steps
B.4.1 Cut out a specimen of the central 150mm×200mm area of the flexible barrier
material.
B.4.2 Measure the gas and/or water vapor transmission rate of the unflexed sample
according to the relevant test method.
B.4.3 Measure the gas and/or water vapor transmission rate of the sample after the
flexing test according to the relevant test method.
B.5 Result recording
Record the gas and/or water vapor transmission rate of the sample before and after the
flexing test.
......
YY/T 0681.12-2014
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.040
C 31
Test methods for sterile medical device package –
Part 12: Flex durability of flexible barrier films
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 01, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Overview of test method ... 5
4 Significance and application ... 6
5 Instruments and reagents ... 6
6 Preparation of specimen ... 8
7 State conditioning ... 8
8 Procedure ... 8
9 Report ... 10
Appendix A (Informative) Precision and bias ... 11
References ... 12
Foreword
YY/T 0681 “Test methods for sterile medical device package” is divided into the
following parts:
- Part 1: Test guide for accelerated aging;
- Part 2: Seal strength of flexible battier materials;
- Part 3: Internal pressurization failure resistance of unrestrained packages;
- Part 4: Detecting seal leaks in porous packages by dye penetration;
- Part 5: Detecting gross leaks in medical packaging by internal
pressurization (bubble test)
- Part 6: Evaluation of chemical resistance of printed inks and coatings on
flexible packaging materials;
- Part 7: Evaluating inks or coating adhesion to flexible packaging materials
using tape;
- Part 8: Coating/adhesive weight determination;
- Part 9: Burst testing of flexible package seals using internal air
pressurization weight restraining plates;
- Part 10: Test for microbial barrier ranking of porous package material;
- Part 11: Determining integrity of seals for medical packaging by visual
inspection;
- Part 12: Flex durability of flexible barrier films;
- Part 13: Slow rate penetration resistance of flexible barrier films and
laminates.
This part is Part 12 of YY/T 0681.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
This part was formulated with reference to ASTM F392-1993 "Flex durability of
flexible barrier films".
Please note that some elements of this document may involve patents. The
issuer of this document is not responsible for identifying these patents.
This part shall be under the jurisdiction of the National Technical Committee for
Test methods for sterile medical device package -
Part 12: Flex durability of flexible barrier films
1 Scope
This part of YY/T 0681 includes the determination of the flex durability of flexible
barrier films. In this test method, the formation of pinhole is used as the criterion
for determining the damage.
Other tests such as gas transmission may also be used instead of pinhole tests.
Note: Appendix A gives the precision and bias of the test methods as specified
in this standard.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 2918 Plastics - Standard atmospheres for conditioning and testing
3 Overview of test method
3.1 Unless otherwise specified, perform the rubbing test on the flexible barrier
film specimen under standard atmospheric conditions (23 °C and 50% relative
humidity). The rubbing conditions, the number of rubbing and the degree of
rubbing vary with the type of specimen structure. The rubbing action consists
of a torsional movement and a subsequent horizontal movement (in most
cases). This repeated twisting and compression of the film specimen. The
frequency is 45 times/min.
3.2 Determine whether the rubbing test causes damage by measuring pinholes
formed in the structure. Pinholes are measured by the use of dyed turpentine
to determine whether the white background is contaminated with pinholes. In
addition, the tester may use other damage criteria, such as gas penetration or
water vapor penetration.
3.3 The various test conditions are summarized as follows:
5.6 White paper, which is uncoated paper of at least the same size as the film
specimen.
5.7 Turpentine (stained, anhydrous), add 5 g of anhydrous calcium chloride
and 1.0 g of red dye solution which is soluble in oil into 100 g turpentine
(chemically pure, relative density 0.860 ~ 0.875 at 15 °C). Stopper the container;
shake it uniformly. Let it stand for at least 10 hours, during which shaking it from
time to time. Use dry filter paper to filter it at a temperature of about 21 °C and
store it in an airtight bottle.
Note: Note that the use of these materials requires corresponding protection, to avoid
hazards caused by skin exposure, inhalation, flammability.
6 Preparation of specimen
6.1 The sample is cut into 200 mm × 280 mm sheets. 200 mm dimension is the
test direction. This is also the shaft direction of rubbing tester.
6.2 Perform rubbing tests on four samples in each of the machine and
transverse directions. In addition, take four unrubbed control samples at
positions adjacent to the sample in two directions for pinhole test.
6.3 Do not seal or do not use adhesive tape to stick the both sides of the sample.
Let it remain opening. Use the double-sided pressure-sensitive tape with a
width of not more than 13 mm to bond the unsealed specimen into a cylindrical
shape suitable for the test machine’s shaft.
7 State conditioning
According to the provisions of GB/T 2918, condition the sample under the
condition of relative humidity (50 ± 5)% and (23 ± 2) °C for at least 24 h (unless
otherwise specified between the supplier and the purchaser).
8 Procedure
8.1 Test environment
Unless otherwise specified, the rubbing test is performed under the conditions
described in Chapter 7.
8.2 Rubbing conditions
8.2.1 Condition A
8.2.1.1 Setting of rubbing tester
8.3.2 Use the tape to adhere the sample to white paper.
8.3.3 Use a brush to apply the stained turpentine solution onto the sample;
brush several courses. Let it stand for 1 min.
8.3.4 After 1 min, use the absorbent toilet paper to wipe off the dyed turpentine.
Apply pressure against the white background paper when wiping.
8.3.5 Remove the specimen from the paper and count the penetration points
on the paper as pinholes. If the color maps overlap but a clear center mark can
be seen, it is counted as separate pinholes. Count all the penetration points,
regardless of their size, even if only the size of the needle tip is considered as
a pinhole; meanwhile only the pinhole in the area of 150 mm × 200 mm is
counted.
9 Report
9.1 The number and average of pinholes per 300 cm2 of each specimen in the
four machine directions and four transverse test samples.
9.2 Any abnormal damage, such as tearing.
9.3 Number of pinholes in the control specimen which was not rubbed according
to the procedures in Chapter 8 (this is used to determine whether pinholes are
already present on the film and not caused by the rubbing test). The values and
averages are reported using "unrubbed control pinholes".
9.4 The test method used, including the number of cycles, complete rubbing or
partial rubbing.
9.5 State conditioning and test environment of the samples used.
9.6 Sample thickness and structure (if appropriate).
......
| Standard ID | YY/T 0681.12-2022 (YY/T0681.12-2022) | | Description (Translated English) | Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.20 | | Word Count Estimation | 11,167 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY/T 0681.12-2014 | | Drafting Organization | Shandong Medical Device Product Quality Inspection Center, Shanghai Jianzhong Medical Device Packaging Co., Ltd., DuPont (China) R&D Management Co., Ltd., Henan Yadu Industrial Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies a test method for the rub resistance of soft barrier materials. This standard applies to the test of the rub resistance of soft barrier materials. | | Standard ID | YY/T 0681.12-2014 (YY/T0681.12-2014) | | Description (Translated English) | Test methods for sterile medical device package. Part 12: Flex durability of flexible barrier films | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 9,958 | | Date of Issue | 2014/6/17 | | Date of Implementation | 2015/7/1 | | Quoted Standard | GB/T 2918 | | Adopted Standard | ASTM F392-1993, NEQ | | Drafting Organization | Shandong Province Quality Inspection Center for Medical Devices | | Administrative Organization | National medical infusion Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to pinhole formation damage as determined whether or not the judge in the final sterilization packaging. This Standard specifies the test method for the determination of anti-rub soft barrier film properties. | | Standard ID | () | | Description (Translated English) | (Technical specifications for ceramic capacitive sensor type partial discharge monitoring devices of 35kV and below) | | Sector / Industry | Chinese Industry Standard | | Date of Issue | 2023-10-11 | | Date of Implementation | 2024-04-11 | | Issuing agency(ies) | National Energy Board |
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