Here above is the summary of the ASTM F 1980 for Biomedical Products for Sterile Barrier Testing. The following assumptions have to be made below.
1. Q10 is presumed to be 2. This is the aging factor.
2. It is not advisable to test the accelerated aging above 55 C, as the materials, mainly polyimide plastics and PET materials will melt.
In essence, if the storage temperature of your biomedical product is 25 C, with an expected shelf life of 3 years or 36 months, therefor if you set the oven temperature to 55 or 30 C ABOVE the storage temperature, the Accelerated Aging Factor is 8.
Therefore, the product 'ages' 8 times faster at 55 C ; hence for 36 months at 25 C, what you need to do to achieve the same result (by aging) through accelerated aging means is then to
> set temperature of oven to 55 C
> Keep it there running at 55 C continuously for 36 / 8 or 4.5 months.
In summary
a) Typical (most common) temperature settings : 50 C 55 C or 60 C
b) Typical Humidity Settings : 50 % 55 % or 60 %.
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