Standard Number: YY/T 0681.16-2019(YY/T0681.16-2019)
Chinese:无菌医疗器械包装试验方法 第16部分:包装系统气候应变能力试验
English:Test methods for sterile medical device package-Part 16:Test for climatic stressing of packaging system
Effective Date:2020-06-01
ICS:11.080.040
Standard Applicability:This standard establishes a harmonized benchmark for the laboratory evaluation of the ability of sterile medical device packaging systems to provide protection from damage or change to the product under climatic strains to which it may be subjected during the circulation cycle. This standard applies as a stand-alone test for evaluating the climatic strain capability of a packaging system; it also applies to conditioning methods prior to tests required for overnight or two-day supply of a packaging system as a single package. This standard does not apply to the climatic strain test of packaging systems for refrigerated, frozen or cryogenic storage and transportation.
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