YY/T 0681.4-2021: Translated English of Chinese Standard. (YYT0681.4-2021, YY/T 0681.4-2021): Test methods for sterile medical device package -- Part 4: Detecting seal leaks in porous packages by dye penetration
https://www.chinesestandard.net, 2021 M10 2 - 19 pages
This Part of YY/T 0681 specifies the test method for detecting seal leaks in porous packages by dye penetrant. This Part applies to the detection of channel, whose package sealing area is greater than or equal to 50 ??m, that is composed of transparent materials and porous materials. This Part does not apply to porous materials that are dyed due to wicking within 5 s; it does not apply to situations where the dye penetrant is not much different from opaque materials.
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Significance and application
Appendix A Informative Precision and bias of test methods
Appendix B Informative False positive guidelines
accuracy amount Appendix applicable aqueous solution Artificially Average value Standard bend channel Coated TYVEK coloring agent Completely Conditioning confidence container correct recognition cutting tool defect definitions drip method dye penetrant Edge immersion method entire sealing excess false negative false positive fiber flexible packaging material folded formed four sides glue Harmful Indicator injection method inspect Laboratory Average value leakage point leaks less liquid Material 3 Material Material 4 Material Material 5 Average measure needs observation occur opening optical magnifying glass path pierce porous material positive and false precision and bias prepare recommended recorded results of correct Sample Laboratory Average sealed on four sealing area sealing edge sealing side separate show the results significantly signs skirt specified surface tension Table Table A.1 test method Test sample toluidine blue transparent material transparent surface TYVEK With defect value Standard deviation wicking agent width wire