YY/T 0681.16-2019: Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system

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Scope

This Part of YY/T 0681 specifies the unified benchmark for evaluating the capability of the
sterile medical device packaging system to protect the product from damage or change under
the climatic stressing that the sterile medical device packaging system may withstand during
the circulation cycle in the laboratory.
This Part is applicable as an independent test for evaluating the climatic resilience of the
packaging system; it is also applicable as a method of conditioning the packaging system as a
single package before the test required for overnight or two-day supply.
This Part does not apply to the climatic resilience test of refrigerated, frozen or low-temperature
storage and transportation packaging systems.

Basic Data

Standard ID	YY/T 0681.16-2019 (YY/T0681.16-2019)
Description (Translated English)	Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.080.40
Word Count Estimation	6,661
Date of Issue	2019
Date of Implementation	2020-06-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies a uniform benchmark for evaluating the ability of sterile medical device packaging systems to provide product protection from damage or change under the climatic strains that may be endured during the distribution cycle within the laboratory. This standard applies as an independent test to evaluate the climatic resilience of a packaging system; it also applies to a method of conditioning the packaging system as a single package before the test required for overnight or two-day supply. This standard does not apply to the climatic resilience test of refrigerated, frozen or low temperature storage and transportation packaging systems.