Ambient temperature_how we claim storage condition in label?

#1
Hello everyone

I have a question about ambient temperature for accelerate aging study of medical device.

If we set ambient temperature at 25℃, can we claim that our product can store at 1-30℃?

For your information, we set accelerated aging temperature at 60℃.
 
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#2
You can only label for storage conditions based on the data that you have available.

I am sure your notified body (or other regulatory agency) will ask for objective evidence to support the storage conditions of the label. If you don't have the data to support 1-30℃, they will ask you to amend the labeling accordingly.

We've been asked to do this for several products during EC conformity assessments.

Hope this helps.
 
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