Hello to everybody!
I read USP,EP and guides related med.dev. issue and I couldn't find anything about storage conditions. I know that depends on few things (material, characteristics of the product ...stability testing....etc.), but generally, for example Nelathon catheter made from PVC, is there any recommendation for storage conditions - temperature and humidity?

Have a nice day!

I don't know of any generalized guideline or industry practice regarding storage conditions and limitations for catheters. There is too much variation among different device types in material types, combinations and process effects.

As you note, regulations require that defined storage requirements be based on objective analysis and, where applicable, on testing results. Storage requirements for sterile devices in barrier packaging, for instance, must be consistent with those conditions for which the product and its packaging (or in a family context, an appropriate challenge device and packaging) have been tested via accelerated aging, generally verified by real time aging when applicable.

So, in regard to your particular device: how much accelerated aging data do you have, and on what nominal storage condition was the acceleration-condition based? Based on your engineering knowledge of the materials and processes involved, what environmental conditions could adversely affect that tested life?

So far, we are performing only ongoing stability tests. We confirmed stability of our product for period of 5 years (controled storage conditions 15-25° C and 30-70% rh).
And now we would like to change temperature limits from 5-25°C because of some resons...what to do?

"We confirmed stability of our product for period of 5 years (controlled storage conditions 15-25° C and 30-70% rh)."

May ask how did you confirm the above information? Did you test it by yourselve or third party lab? How do you know it is 5 years?

We have stability plan/protocol (very similar with pharmaceutical industry, matrixing stability schedule ) and according to that are performing/performed tests on samples. Some of the tests (visual inspection, physical characteristics) we are doing in our lab, and other tests (sterility, analytical tests...) are performing by third party lab because we are not able to do it.

My company makes medical devices for ISO13485 companies, but we are not yet ISO13485 ourselves. All of our quality requirements come from the customer (including storage requirements/protocols). Can you get guidance from your customer or end user? Don't you need to get approval from them before changing storage conditions that are part of your process anyway?