YY/T 0681.4-2010
YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
Abstract
This part of YY/T 0681 specifies the method for detecting channels greater than or equal to 50 μm in the sealed edge formed by silk threads between transparent films and breathable materials, and identifying the materials and procedures used to locate the channels. A dyeing solution is applied locally to the sealed edge for leakage testing. After a specified period of contact with the dyeing solution, the dye penetration on the packaging is visually inspected.
This test method is intended for the inspection of the sealed edges formed between transparent films and breathable materials. This test method is only applicable to breathable materials that can retain the dyeing solution and do not cause the entire sealed area to discolor within a minimum time of 20 seconds. Uncoated paper is particularly susceptible to dye penetration and must be carefully evaluated when using this test method.
This test method requires that non-transparent packaging materials provide good contrast for the dyeing solution.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Replaced |
| Standard Code | YY/T 0681.4-2010 |
| CCS | Generally, it refers to microsurgical instruments |
| ICS | Disinfection and packaging |
| Implement Date | 2012-06-01 |