Online Quote System - Accelerated Aging
Standards for Accelerated Aging
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:
Most Common Variables For Accelerated Aging
- Accelerated Test Temperature are typically between 50 to 60C, most common 55°C.
- Ambient storage temperature is typically between 22°C to 25°C. 22°C will results in the shortest test duration.
- Conservative / common Q10 is 2 for medical devices.
- Relative Humidity (RH) is not a factor in the Arrhenius equation. However, RH should be kept under 30% so material is not damaged.
- The expiry date of a medical product is commonly based on its manufacture date. Therefore, some add an extra month to the aging study to allow for sterilization, etc. For example, a 12 month shelf life is simulated based on 13 months.