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 penetrationhttps://www.chinesestandard.net, 2 окт. 2021 г. - Всего страниц: 19 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. |
Содержание
Foreword | 5 |
Scope | 6 |
Significance and application | 7 |
Security measures | 8 |
Procedure | 9 |
Report | 10 |
Appendix A Informative Precision and bias of test methods | 12 |
Appendix B Informative False positive guidelines | 17 |
References | 19 |
Часто встречающиеся слова и выражения
20 times optical 22/24 Without defect Average value Standard Coated TYVEK coloring agent correct identification Sample Detecting seal leaks drip method drip the dye dropper or pipette dye penetrant penetrating Edge immersion method entire sealing area entire sealing edge equal to 20 false negative flexible packaging material glass for detailed hydrostatic pressure identification Sample Laboratory immersion operation internal sealing area laboratory 6521 Laboratory Average value leakage point leaks in porous Material 3 Material Material 4 Material Material 5 Average method and drip method test results number of test optical magnifying glass packages by dye penetrant 9.1 Method penetrant will penetrate Porous combination porous material porous packages positive and false positive no channel precision and bias results of correct Sample Laboratory Average sealed on four sealing side Table A.5 Table A.7 test method Test sample toluidine blue transparent material transparent surface TYVEK With defect unglued TYVEK value Standard deviation wicking agent