YY/T 0681.14-2018: Test methods for sterile medical device package - Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air

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Scope

This Part specifies the methods for testing the microbial barrier for porous
packaging materials under moist conditions and with passage of air.
The test methods given in this Part apply to the packaging materials for
terminally sterilized medical devices.

Basic Data

Standard ID	YY/T 0681.14-2018 (YY/T0681.14-2018)
Description (Translated English)	Test methods for sterile medical device package - Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.080.040
Word Count Estimation	13,136
Date of Issue	2018-11-07
Date of Implementation	2019-11-01
Quoted Standard	GB/T 450-2008
Regulation (derived from)	Announcement No. 87 of 2018 by the State Drug Administration
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the test methods for microbial barrier tests for wet and dry conditions. The test methods given in this standard are applicable to the packaging materials of terminally sterilized medical devices.