YY/T 0681.16-2019 English PDF (YYT0681.16-2019)
YY/T 0681.16-2019 English PDF (YYT0681.16-2019)
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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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YY/T 0681.16-2019: Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system
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.
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