In Vitro irritation testing according to ISO 10993-23

M

Manel Mou

Starting to get Involved
#1
#1
Please,
1/ for EU submission, are oral mucosal in vitro models accepted by NB for performing In Vitro irritation testing on MD according to ISO 10993-23?? Does any one have any feedback?
2/Can we evaluate the IN vitro cytotoxicity and irritation of a MD in the same time via ISO 10993-23?
3/how can we prepare sample extract for in vitro irritation testing if a MD is not suitable for extraction( a cream product that laboratory said that is hard to extract for extractable testing)?
THANKS in advance for your answer.
 
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planB

planB

Super Moderator
#2
#2
ad 1: You might want to talk to your NB about your plans prior to initiating a non-common/novel or non-standard approach: principally, NBs are open to state-of-the art, scientifically sound and justified approaches.
ad 2: For cytotoxicity testing, refer to ISO 10993-5 only, as this is the established standard for testing this specific biological endpoint.
ad 3: Can your device be regarded as being dissolved or absorbed under conditions of use? If yes, you might want to have a look into ISO 10993-12:2021, sections, 10.3.2, 10.3.11 and C.7.

HTH,
 
M

Manel Mou

Starting to get Involved
#3
#3
planB said:
ad 1: You might want to talk to your NB about your plans prior to initiating a non-common/novel or non-standard approach: principally, NBs are open to state-of-the art, scientifically sound and justified approaches.
ad 2: For cytotoxicity testing, refer to ISO 10993-5 only, as this is the established standard for testing this specific biological endpoint.
ad 3: Can your device be regarded as being dissolved or absorbed under conditions of use? If yes, you might want to have a look into ISO 10993-12:2021, sections, 10.3.2, 10.3.11 and C.7.

HTH,
Click to expand...
thank you for your answer.
 
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