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Medical device non sterile packaging requirement
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Medical device non sterile packaging requirement
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class ii medical device, medical devices, non-sterile medical devices, packaging (general), packaging standards and specifications
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  Post Number #1  
Old 23rd March 2018, 08:24 AM
noorain

 
 
Total Posts: 16
Please Help! Medical device non sterile packaging requirement

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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  Post Number #2  
Old 4th April 2018, 05:24 PM
yodon

 
 
Total Posts: 1,144
Re: Medical device non sterile packaging requirement

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.
Thanks to yodon for your informative Post and/or Attachment!
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