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Donegalquality
Stability Testing of Medical Devices for Home Use.
Accelerated testing of Medical Devices and their packaging is normally based on a shelf temperature of 20 to 25 Deg C (typically 22 Deg C). This assumes storage in a relatively controlled environment e.g. a warehouse.
Has anyone used a different shelf temperature assumption for devices for home use; 30 Deg C for example?
If the device is to be used worldwide, at worst case it could be stored for the duration of its shelf life in a home without air conditioning. In somewhere like Khartoum, Sudan the average (day/night inclusive year round) temperature is approx. 30 Deg C (86 F).
Is it necessary to conduct the shelf aging at 30 deg C for a home use product, which could in theory be subject to the above conditions ? How have other companies dealt with this issue?
Accelerated testing of Medical Devices and their packaging is normally based on a shelf temperature of 20 to 25 Deg C (typically 22 Deg C). This assumes storage in a relatively controlled environment e.g. a warehouse.
Has anyone used a different shelf temperature assumption for devices for home use; 30 Deg C for example?
If the device is to be used worldwide, at worst case it could be stored for the duration of its shelf life in a home without air conditioning. In somewhere like Khartoum, Sudan the average (day/night inclusive year round) temperature is approx. 30 Deg C (86 F).
Is it necessary to conduct the shelf aging at 30 deg C for a home use product, which could in theory be subject to the above conditions ? How have other companies dealt with this issue?