ISO 10993 - Replacing Sensitization Test with Systemic Toxicity Test?

W

webcrawler

#1
Hi there, could someone please help me with this:

According to ISO 10993, the 3 biocompatibility tests required for our product is Cytotoxicity, Sensitization and Irritation. Can we replace the Sensitization test with the Systemic toxicity test instead?:confused:
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Do you have a science-based rationale for why such a change would more sensitively demonstrate all of the basic aspects of biocompatibility for your material type and extent of contact?
 
R

rclanzillotto

#3
I would discuss the merits of this with your toxicology lab. My experience is it is difficult to waive the core three tests when they are required. Good Luck Rich
 
W

webcrawler

#4
Sensitization test is a skin patch test of the extracts on the animals but systemic injection is more rigorous as it involves injection of the extracts intravenously but only 1 animal is used.
Is this good enough?
 

Qara123

Involved In Discussions
#5
I think it is not good enough. First, Sensitization and Systemic Toxicity are different tests. Second, I do not think using only 1 animal is sufficient to account for test bias, etc.

Sensitization (Maximization) - This basically tests whether the device extract has the potential to cause sensitization (i.e., an immunological response due to repeated exposure). Note that this involves injecting the extract intradermally. This is similar to a person eating shell-fish for 20 years with no problems and suddenly starts to get a rash when he eats shell-fish.

Systemic Toxicity - This test tries to determine whether the device extract is toxic and will cause the body to breakdown. This is similar to... eating poison.

Q
 
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