YY/T 0681.2-2010 PDF English
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Test methods for sterile medical device package. Part 2: Seal strength of flexible battier materials
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YY/T 0681.2-2010: Test methods for sterile medical device package. Part 2: Seal strength of flexible battier materials
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0681.2-2010
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.080.40
C 31
Test methods for sterile medical device package - Part 2.
Seal strength of flexible barrier materials
Issued on. DECEMBER 27, 2010
Implemented on. JUNE 01, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Significance and application... 6
5 Interference... 7
6 Instruments... 7
7 Sampling... 8
8 Aging and status conditioning... 8
9 Procedures... 8
10 Reports... 10
Appendix A (Normative) Interference factors of test... 12
Appendix B (Normative) Type of seal failure... 14
Appendix C (Informative) Precision and bias of test methods... 16
Appendix D (Informative) Laboratory collaborative study background, description,
analysis... 19
References... 23
Foreword
The general title of YY/T 0681 is "Test methods for sterile medical device package",
which consists of 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.
This Part is Part 2 of YY/T 0681.
Other parts will be developed in succession 1).
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part of YY/T 0681 modifies and adopts ASTM F88-06 "Standard test method for
seal strength of flexible barrier materials". This Part is identical to ASTM F88-06 in
terms of technical content; there are mainly editorial differences and differences in cited
standards. The unified description, for the use of non-legal measurement units in
Appendix C and Appendix D, is as follows. 1 in (inch) = 1000 mil = 25.4 mm.
This Part shall be under the jurisdiction of the National Technical Committee for
Standardization of Medical Infusion Devices.
Drafting organization of this Part. Shandong Medical Device Product Quality
Inspection Center.
1 Other parts will be converted to the ASTM F test method standard for medical packaging
The main drafters of this Part. Wu Ping, Chen Fang, Dong Dandan.
Test methods for sterile medical device package - Part 2.
Seal strength of flexible barrier materials
1 Scope
This Part of YY/T 0681 covers the measurement of the seal strength of flexible barrier
materials.
This test can be used to test the seal, between flexible and rigid materials.
Sealed samples, which comply with this test method, may come from any source,
EITHER formed in the laboratory OR from commercial sources.
This test method can measure the separation force, which is required to seal the
specimen, AND also identify the type of specimen failure.
Note. Appendix C and Appendix D respectively give the precision and bias of the test methods,
which are specified in this standard, as well as the relevant information for their determination.
2 Normative references
The following documents are essential for the application of this document. For dated
references, only the dated version applies to this document. For undated references, the
latest edition (including all amendments) applies to this document.
GB/T 2918 Plastics - Standard atmospheres for conditioning and testing
3 Terms and definitions
The terms and definitions, as defined in ISO 11607-12), as well as the following terms
and definitions, apply to this document.
3.1
Average seal strength
Under test conditions, the average force per unit seal width, which is required to
gradually separate a flexible material from a rigid material OR from another flexible
2 The Chinese standard, which is corresponding to ISO 11607-1, is GB/T19633.1 (under revision)
material.
3.2
Flexible
Indicates a material whose flexural strength and thickness allow it to be rotated 180°.
3.3
Maximum seal strength
Under test conditions, the maximum force per unit seal width, which is required to
gradually separate a flexible material from a rigid material OR from another flexible
material.
4 Significance and application
4.1 Seal strength is a quantitative measure, which is used for process validation, process
control, process capability.
4.2 When adhesive failure (peeling) occurs on the sealing surface, report the measured
adhesive strength value. Cohesive failure, delamination, or damage elsewhere, in the
bond of the specimen, indicates the failure of the substrate, rather than the sealing
interface, is a factor limiting the strength of the package.
4.3 When testing materials, part of the measured force value may be formed by the
bending portion, NOT just the seal strength. A number of different schemes for holding
the sample, at different angles to the stretching direction, are envisaged, to control the
bending force.
5 Interference
Measured seal strength may be affected by specimen properties rather than real seal
strength.
6 Instruments
6.1 Tensile testing machine
The testing machine shall have fixtures, that can be separated at a constant speed, as
well as a force-measuring system. The force-measuring deformation displacement of
the force-measuring system, within the measuring range, is not greater than 2% of the
elongation of the sample.
6.2 Sample cutter
Cut the sample into widths of 15 mm, 25 mm or 25.4 mm, the tolerance shall be ±0.5%.
7 Sampling
7.1 The number of samples shall be selected, so that the measurement is representative.
8 Aging and status conditioning
8.1 When there is no information to show that, the heat-sealing strength of the tested
material can be stabilized in a relatively short period of time, carry out the status
conditioning and test, for the sealed material, according to GB/T 2918.
8.2 The state conditioning time of heat sealing can be shortened by testing, provided
that the sealing strength can be stabilized.
8.3 In order to meet specific test purposes, such as measuring seal strength at specified
storage or transport temperatures, it may be necessary to modify the status conditioning
process.
9 Procedures
9.1 Calibrate the tensile testing machine, as recommended by the manufacturer.
9.2 Cut the seal specimens to the dimensions, as shown in Figure 2.The edges of the
sample shall be neat and perpendicular to the sealing direction; the wings may be shorter
than those shown, depending on the size of the tester's fixtures.
In millimeters
9.3 Clamp the specimen in the tensile testing machine. The sealing area of the sample
shall be substantially in the center of the two fixtures. The recommended distance
between fixtures (the initial unstretched length of the sample) is.
9.4 Fix the specimen in the fixture in the center of the fixture, so that the sealing line of
the specimen, in the fixture, is perpendicular to the tensile direction, AND maintain
sufficient slack, so that the specimen is not stressed before the test starts.
9.7 For each test cycle, report the maximum force that the sample withstands to failure,
AND identify the type of failure of the specimen.
9.8 If the specimen is peeled off in the sealing area, whether it is adhesive failure,
cohesive failure, or delamination, the average peel force can be used to characterize the
peel performance, which can be directly measured by the testing machine, during the
test.
9.9 A curve of force, which is corresponding to fixture movement, is useful for
interpretation of results. Therefore, the testing machine should have a program for
drawing the curve.
9.10 Other variables, such as the energy required to cause the seal to separate, can be
used to describe the strength of the seal, when the fixture movement only results in seal
peeling.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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