Chemical Testing on Medical Devices - Solutions in a container closure system (bag)

[NJin189]

I am looking for guidance on how to do chemical testing on devices which are solutions in a container closure system (bag)? Should E&L testing be carried out on the bag or are there other approaches to consider?

 

[planB]

NJin,

Since you are mentioning, "E&L", I assume that your question is in the framework of ISO 10993-18, Chemical characterization of medical device materials within a risk management process? If yes, justify your E&L testing of your closure system in line with ISO 10993-1, section 6.3.1 (a) "Testing shall be performed on the final medical device, or representative samples from the final device or materials processed in the same manner as the final medical device"

In case your packaged solutions allow direct chemical analysis, you may also consider investigating your device directly for potential extractables and leachables.

HTH,