YY/T 0681.12-2014 (YY/T0681.12-2014, YYT 0681.12-2014, YYT0681.12-2014)
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Test methods for sterile medical device package. Part 12: Flex durability of flexible barrier films
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| YY/T 0681.12-2022 | English | 230 |
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Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials
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YY/T 0681.12-2022
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Newer version: YY/T 0681.12-2022 Standards related to: YY/T 0681.12-2022
| 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. | 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).
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