YY/T 0681.4-2010 (English Version) PDF

Scope: This part of YY/T 0681 specifies the materials and procedures used to detect channels greater than or equal to 50 μm in the sealing edge formed by silk threads between transparent films and breathable materials, and to identify the location of the channels. A dyeing solution is locally applied to the sealing edge for leakage testing. After contact with the dyeing solution for a specified period of time, the dyeing penetration on the package is visually inspected. This test method is intended for the examination of sealing edges formed between transparent films and breathable materials. This test method is limited to breathable materials that can retain the dye solution without discoloring the entire sealing area for a minimum time of 20 seconds. Uncoated paper is particularly susceptible to dye solution penetration and must be carefully evaluated when using this test method. This test method requires opaque packaging materials that provide good foil for the dyeing solution.

YY/T 0681.4-2010 history

2021 YY/T 0681.4-2021 Test methods for sterile medical device packaging Part 4: Determination of seal leakage of breathable packaging by dye solution penetration method
2010 YY/T 0681.4-2010 Test methods for sterile medical device package.Part 4 :Detecting seal leaks in porous packages by dye penetration