YY/T 0681.2-2010Test methods for sterile medical device package - Part 2: Seal strength of flexible barrier materials (English PDF)

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.

--- Other parts will be converted to the ASTM F test method standard for medical packaging.

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.

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

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. […]