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

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https://www.chinesestandard.net, 2021 M10 2 - 19 pages
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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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Contents

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

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About the author (2021)

https://www.chinesestandard.net specializes in providing translation services of all Chinese Standards.

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