Extraction Procedures - One with a Polar and One with a Non-Polar medium

G

Grossbouff

#1
I apologize for not starting a new subject but I couldn't find how to do it.
I have a question related to ISO 10993 though.

The norm advices to test 2 extraction procedures: one with a polar and one with a non-polar medium. As non-polar medium they give sesam oil as an example. In annex C of ISO 10993 (5), it is stated that the extract should be tested on cells at a concentration of 100%. I suppose noone could expect cells to survive an exposition to 100% sesam oil for 24h?!
How is sesam oil intended to be used then?
Should it be diluted? How much? Did I miss something?
Many thanks in advance.
 
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harry

Super Moderator
#2
M

MIREGMGR

#3
I have a question related to ISO 10993 though.

The norm advices to test 2 extraction procedures: one with a polar and one with a non-polar medium. As non-polar medium they give sesam oil as an example. In annex C of ISO 10993 (5), it is stated that the extract should be tested on cells at a concentration of 100%. I suppose noone could expect cells to survive an exposition to 100% sesam oil for 24h?! How is sesam oil intended to be used then? Should it be diluted? How much?
In my experience, sesame oil often is used as the testing oil in Asian laboratories; olive oil in Europe; and cottonseed oil in USA. What standard-version are you using?

In any case, I don't see any reference in ANSI/AAMI/ISO 10993-5:2009 to extraction with oil, exposure of cultures to an oil environment, or polar and non-polar processes.

ANSI/AAMI/ISO 10993-10:2010 provides for polar and non-polar processes and utilizes oil as a carrier for non-polar irritation and skin sensitization testing. That testing however is for non-cellular extractables, not for cell cultures.
 
G

Grossbouff

#4
Thank you Harry, I'll do better next time!

Miregmgr: Thank you for taking the time to reply.
The extraction procedure is described in point 10 of ISO 10993-12:2009.
The necessity to use both polar and non-polar extraction vehicles is clearly stated in point 10.3.5. They state cottonseed or sesame oil.
ISO being international, I would expect the norm to be the same overall in the world?!

PS: sorry if I don't use the right vocabulary but my documents are in german and I am biologist, not lawyer.
 
M

MIREGMGR

#5
The extraction procedure is described in point 10 of ISO 10993-12:2009. The necessity to use both polar and non-polar extraction vehicles is clearly stated in point 10.3.5. They state cottonseed or sesame oil.
Sorry, I was thrown off by your earlier seeming reference to ISO 10993-5.

As I don't have ISO 10993-12 on hand, I can't address it in depth. However, the abstract at the ISO website says:
ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:
  • test sample selection;
  • selection of representative portions from a device;
  • test sample preparation;
  • experimental controls;
  • selection of, and requirements for, reference materials;
  • preparation of extracts.
ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Your original question, I think, had to do with live cell survival:

I suppose noone could expect cells to survive an exposition to 100% sesam oil for 24h?!
and as it appears from the abstract that ISO 10993-12:2012 is not intended to define conditions for live cell exposure, the question seems to be moot.
 
G

Grossbouff

#6
This is becoming very exciting because it seems that only several words can do the difference here!
Please can you give me the URL address where you found this sentence?

On this page for ISO 10993-12:2002 it is written:
.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=35331
(please add www before the URL, I am not allowed to post links)

"The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated."

And in my german document ISO 10993-12:2009, if I translate in english it is written: "This part of ISO 10993 is not applicable to material and products which contain live cells"

Both statements are clearly different from what you wrote "ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells."

This is why it is VERY important for me that you can show me where you found that!!

Thanks for your invaluable help!
 
G

Grossbouff

#7
OK I found your reference. It seems that this slight but critical correction was done in the 2012 version. Or perhaps it is a difference between the german and the english version.
Anyway a big THANK YOU for your help!
 
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