Stability (Accelerated Life) Testing of Medical Devices for Home Use

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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?
 
D

Donegalquality

I am slightly surprised that there have been no replies to my query yet. Is this perhaps something of a Pandora's box?
 
V

Vincnet

Hello Donegalquality,
I asked a question 7 years ago and th repply I had from abhishek could help you http://elsmar.com/Forums/showthread.php?t=7053

What I would do is: in your risk management assess normal use condition and impact of bad storage then for the product validate a storage for the said conditions (see that for abhishek 25°C or 30°C wouldn't make any difference in the validation parameters i.e. 40°C). update you RM eventually mitigation residual risk by labelling.

V
 
D

Donegalquality

Thank you, Vincent.
That is one option that I will certainly consider.
 
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