YY/T 0681.13-2014Test methods for sterile medical device package - Part 13: Slow rate penetration resistance of flexible barrier films and laminates (English PDF)

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 13 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 F1306-1990 "Slow rate penetration resistance of flexible barrier films and laminates".

1 Scope

This part of YY/T 0681 is applicable to determine the penetration resistance of the anti-drive probe of flexible barrier film and laminates. In this test, biaxial stress is applied to the material at a constant test rate at room temperature, until penetration occurs; the force, energy and elongation before penetration are measured.

Note: Appendix A gives the precision and bias of the test methods as specified in this part.

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 (GB/T 2918-1998, idt ISO 291:1997)

3 Terminology

The following terms and definitions apply to this document.

6 Specimen

6.2 The specimen size shall be 76 mm × 76 mm.

7 Instrument preparation

7.1 Set up and operate the instrument according to the instrument's operation manual.

7.2 Install the probe.

7.3 Place the probe above the clamp and align it.

8 Number of specimens

Test at least 5 specimens for each sample.

9 State conditioning

9.1 According to the provisions of GB/T 2918 before the test, condition the state of the specimen under the conditions of temperature (23 ± 2) °C and relative humidity (50 ± 5) % for at least 40 h.

9.2 Unless otherwise specified in this test method, the test is performed under standard laboratory conditions with a temperature of (23 ± 2) °C and a relative humidity of (50 ± 5) %.

10 Procedure

10.1 Calibrate the test instrument according to the instrument manufacturer's instructions.

10.2 Select the force of the dynamometer in the range of 20% ~ 80% of the range when penetration occurs.

10.3 Use the sample cutter to cut at least five 76 mm × 76 mm specimens for each sample.

10.4 Measure the thickness in the center of the film sample (average of 3 readings).

Note 1: The thickness can be measured by ASTM D374 or GB/T 6672. It is recommended to use Method C or Method D of ASTM D374 first.

Note 2: The accuracy of the thickness measurement methods in Table A.3 is based on ASTM D374.

Appendix A (Informative) Precision and bias