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
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