YY/T 0681.1-2018 Translated English of Chinese Standard. (YYT 0681.1-2018, YY/T0681.1-2018, YYT0681.1-2018): Test methods for sterile medical device package - Part 1: Test guide for accelerated agingThis Part of YY/T 0681 specifies the guide for designed accelerated aging solutions. This Part applies to the rapid determination of the sterile integrity of the sterile barrier system specified in GB/T 19633.1-2015 and the effects that physical properties of its packaging material components are affected by the elapsed time. |
Common terms and phrases
accelerated aging factor Accelerated aging plan accelerated aging results accelerated aging study accelerated aging temperature accelerated aging test Accelerated aging theory acceptable criteria actual-time aging added sub-clause aging process aging result meets aging time point ambient temperature Annex C informative Celsius chemical reaction conditions NOTE confirmed conservative aging factor control humidity effect of humidity expected shelf expiration date Figure C.1 flexible barrier films GB/T guide for accelerated humidity conditions Hygrometer instruments integrity Material and sterile material characterization material properties materials or sterile Meaning and application medical device package methods for sterile nominal shelf packaging system design performance test Q10 value reaction rate real-time aging results real-time aging study relative humidity relative temperature seal strength selected temperature Shandong simulated specified accelerated aging stability test sterile barrier system sterile medical device sterilization process storage conditions Temperature and humidity temperature and relative Temperature limits Test methods test plan test temperature thermometer can directly