P
I hope you can help me...
I'm seeking to understand how to conduct biocompatability (ISO 10993 Series) testing of insulin infusion set components... Here is my issue... The infusion set must be changed at least once each week - but the end user has a cannula / catheter and the tubing against their skin continuously (the site may change - but the 'system' can be construed as being continuously in contact with the skin...
How do I treat the system - Implant Device / Tissue-Bone?
What is Contact Duration - B - Prolonged or C-Permanent?
What is the justification for the two?
What testing do I perform?
Any help appreciated
Nick
I'm seeking to understand how to conduct biocompatability (ISO 10993 Series) testing of insulin infusion set components... Here is my issue... The infusion set must be changed at least once each week - but the end user has a cannula / catheter and the tubing against their skin continuously (the site may change - but the 'system' can be construed as being continuously in contact with the skin...
How do I treat the system - Implant Device / Tissue-Bone?
What is Contact Duration - B - Prolonged or C-Permanent?
What is the justification for the two?
What testing do I perform?
Any help appreciated
Nick
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