Biocompatability (ISO 10993 Series) Testing for Infusion Systems

P

Paranelle

#1
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
 
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BradM

Staff member
Admin
#2
Hello, Nick!

Welcome to the Cove!

It's into the weekend now, and with it being a holiday weekend and all, it might be a bit slow around here for replies.

If you don't get some feedback by Wednesday or so, feel free to repost under it (maybe with some other information) so someone can see it and respond.

Sorry I could not help, but this one is way out of my specialty field!
 
G

Gert Sorensen

#3
Hi Nick,

Welcome to the Cove :bigwave:

I hope you can help me...
I don't have a copy of the standards in front of me, but I will try :)

I'm seeking to understand how to conduct biocompatability (ISO 10993 Series) testing of insulin infusion set components...
Yup, a lot of us have difficulties in that department. 19 standards are a lot to get your head around....

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...
If I were to guess I would say that the defining factor for your testing is not the changing of the infusion set. In my eyes it does not matter if you change the set, the system will be in constant contact, skin and tissue.

How do I treat the system - Implant Device / Tissue-Bone?
Isn't there a classification for injection devices?

What is Contact Duration - B - Prolonged or C-Permanent?
Permanent. The body is subjected to the cannula/catheter for an undefined period of time, but it definitely is not a week or a month, it is real long term.

What is the justification for the two?
One of the standards have a defintion of the periods of time: 1 hour, 24 hours, less than 30 days, etc. I can't remember which one :(


What testing do I perform?
You perform the testing needed regulatorily. In the ISO system, there is a demand to reduce testing on animals, and therefore you have the responsibility to explore testresults on similar products with similar rawmaterials. However, I have heard rumours that FDA does not accept the comparisons, and you should contact an institute such as NAMSA to have this clarified by experts.

I hope this helps a little
 
A

Alchemists

#4
Thanks for the responses... Nick Paranelle is a member of Alchemists Intl - a registered member of the Forums... Here is a clarification...
We are facilitating the development of a device which will use commercially available infusion sets... Do we need to rerun the biocompatability testing previously conducted by the infusion set manufacturers - their devices are already approved for use / commerce.
Thanks,
Alchemists Intl:thanx:
 
G

Gert Sorensen

#5
We are facilitating the development of a device which will use commercially available infusion sets... Do we need to rerun the biocompatability testing previously conducted by the infusion set manufacturers - their devices are already approved for use / commerce.
Thanks,
Alchemists Intl:thanx:
What does your device do?
 
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