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Medical device substance based-leachables

#1
Hello
Our product is a medical device substance based (combination of chemical substances); it is used by its dissolution in water and then a chemical reaction takes place; some initial ingredients disappear by reacting, some others remain in the solution and new resulting ingredients appear(which are mainly the principal ingredients involved in the action of the product); the solution is then used.
Is our product ligible to the definition of leachable substance (chemical removed from a medical device by the action of water or other liquids related to the use of the device(EXAMPLE , degradation products...) according to ISO 10993-17?
can the new resulting ingredients described above be considered as degradation products?

THANK YOU.
 
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#2
Manel Mou,

let's start from the end:

"degradation" is the sum of undesired (physico-)chemical reactions over time ("aging"). From what I understand from your description this is not the case for your product, which is the final solution after dissolution and _desired_ chemical reactions. In case this solution after preparation does not degrade over its life-time in body contact, you would not have to consider degradation effects.

"leachables" are chemicals that migrate from a medical device under (simulated) use conditions. This might be in a worst-case the total of your solution or only certain ingredients depending on their physico-chemical characteristics in relation to the nature of the (patient) body exposure. So I would expect that you may want to use ISO 10993-17 to calculate allowable limits for your leachables (extractables).

Hope this helps,
 
#3
Manel Mou,

let's start from the end:

"degradation" is the sum of undesired (physico-)chemical reactions over time ("aging"). From what I understand from your description this is not the case for your product, which is the final solution after dissolution and _desired_ chemical reactions. In case this solution after preparation does not degrade over its life-time in body contact, you would not have to consider degradation effects.

"leachables" are chemicals that migrate from a medical device under (simulated) use conditions. This might be in a worst-case the total of your solution or only certain ingredients depending on their physico-chemical characteristics in relation to the nature of the (patient) body exposure. So I would expect that you may want to use ISO 10993-17 to calculate allowable limits for your leachables (extractables).

Hope this helps,
Thank you very much for your clarifications.
So we have to consider the ISO 10993-18 for the identification of leachables and then calculate allowable limits using ISO 10993-17?
 
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