Non Sterile Medical Device Environmental Tests

[Wonder]

Hello,

We are looking for some help on defining environmental tests for a non-sterile medical device class III.

The product has 5 years shelf life with storage conditions 0-40°C. We thought of having accelerated ageing studies, but we saw mainly standards for sterile medical device. Do you have any recommendations for defining the tests/standards to be used ?

For transport/packaging tests, we are considering testing according to IEC 60068. Is IEC 60068 suitable for medical devices ? Should we rather test based on ISTA and why ?

Thanks a lot for your help

 

[planB]

Wonder,

some questions ahead:

1) Is your device packaged in a barrier system, maintaining a controlled microbial/cleanliness state or just in protective packaging? Do you intend to demonstrate un-compromised packaging over your labelled shelf life, or compromised product characteristics or both?
2) On what rationale/test is your current shelf life based on?
3) Do you really want to set an upper storage limit at 40°C? The reason I am asking is that such a high limit significantly reduces your acceleration factor which is determined by the difference between accelerated-aging temperature and maximum storage temperature.

For transport tests, you should consider tests that adequately reflect your distribution mode, including the climatic conditions of the regions you are shipping to.

 

[Wonder]

Thanks for helping

1)The device is just in protective packaging. The user need to sterilize it before use. We intend to demonstrate the product is still performing well over the shelf life.
2)The current shelf life is based on similar device shelf life. The product is on the market since a long time, we are updating/renewing documentation/tests data. We are not expecting performance degradation based on product knowledge but we don't have any proper documentation to demonstrate it.
3)Good question, the product is stored in non controlled environment in different countries, that is why we put this range of 0-40°C.

 

[planB]

Wonder,

for accelerated product aging, you may want to refer to AAMI TIR17:2017, Annex J "Accelerated aging programs". You may want to make sure that you initiate real-time aging in parallel. There is also very old FDA guidance still around that may support your risk assessment with regards to shelf life testing.

In case your product is stored at healthcare facilities, labelling room temperature is conservative enough in my opinion: ASTM1980 - 16 says "7.2.2 Room or Ambient Temperature (TRT)—Select a temperature that represents the actual product storage and use conditions. NOTE 2—This temperature is typically between 20 to 25°C. A temperature of 25°C is considered a conservative approach."

Hope this helps,

 

[Ed Panek]

How did you originally estimate shelf life on your first approval?