YY/T 1433-2016Test method of hot seal strength(hot tack)of flexible webs of medical devices (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard contains the laboratory measurement of the heat seal between the thermoplastic surfaces after the formation of the seal in the cooling to ambient temperature before the heat sealing strength (hot strength).

This standard is applicable to the ability to automatically heat the sample and quickly determine the strength of the hot seal during the exact time after the end of the sealing period Test instrument. This standard does not include manual procedures for the use of non-instruments such as springs, joysticks, pulleys and weights.

Note. The result of manual operation will be affected by the operator's technology.

This standard gives two test methods using different thermal adhesive strength test instrument parameters.

Note 1. The difference between the two test methods is mainly reflected in two aspects. a) test the sealing sample when the separation rate of the fixture is different; b) drawing test machine generated test Test the cooling curve of the material, or measure the maximum force observed after setting the delay time. Both of these test methods can be used to measure this test Within the scope of the method and within the capabilities of the instrument used.

Note 2. Appendix A gives a comparison between the two test methods specified in this standard. Appendix B gives the precision and bias of these two test methods.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 2918 Standard conditions for the regulation and testing of plastic specimens

YY/T 0681.2-2010 Test methods for packaging of sterile medical devices - Part 2. Sealing strength of soft barrier materials

3 Terminology

The following terms and definitions apply to this document.