Medical device non sterile packaging requirement

noorain

Starting to get Involved
#1
Hello everyone,
We are kind of stuck in determining the packaging requirements as per MDD and IEC standards.
1. How do we determine Max and min storage temperature and humidity range for a class 2a non-sterile medical device? Is there a test criteria or we directly go with what is mentioned in the IEC standards.
2. Do we have to justify these range of temperature and humidity that we select if so are there any tests ? IEC 60601-1 does not specify any tests for packaging.

If anyone has info on this please share.

Thank you
 
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yodon

Staff member
Super Moderator
#2
First off, look at each component to find the most limited ranges. Second, consider a risk analysis for temperature / humidity excursions (what happens to the device - do you lose basic safety / essential performance?).

Yes, there are temperature and humidity soak tests as part of 60601.

Packaging requirements are just to protect your device during transport and is, indeed, outside the scope of 60601. The requirement originates from the regulations / standards.
 
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