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YY/T 0681.4-2021 English PDF (YY/T0681.4-2021)

YY/T 0681.4-2021 English PDF (YY/T0681.4-2021)

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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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Scope

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 μm, 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.

Basic Data

Standard ID YY/T 0681.4-2021 (YY/T0681.4-2021)
Description (Translated English) Test methods for sterile medical device package - Part 4: Detecting seal leaks in porous packages by dye penetration
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Word Count Estimation 12,150
Issuing agency(ies) State Drug Administration


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