D
I sent a foam hand grip for cytotoxicity testing to ISO 10993-5.
After receiving the results reactivity graded as 1,1,1 noted as mild 50%?
I posed the question to the test house if 1/ mild is a pass or fail.
Their answer was “There is no specification for pass/fail per ISO-10993-5. We can only report the cytotoxicity score and the interpretation.
However, the USP requirement for a pass is that the "test sample does not induce a greater than "2" cytotoxicity score," which is equivalent to a mild reaction”
As I will need to justify my acceptance of this test to use this item on our CE marked products.
How would I do that, are the USP standards a pass/fail type test? Is the test similar enough to reference the ISO to the USP?
Or is their an ISO document or MDD I can use to compare the results.
Thanks
Don
After receiving the results reactivity graded as 1,1,1 noted as mild 50%?
I posed the question to the test house if 1/ mild is a pass or fail.
Their answer was “There is no specification for pass/fail per ISO-10993-5. We can only report the cytotoxicity score and the interpretation.
However, the USP requirement for a pass is that the "test sample does not induce a greater than "2" cytotoxicity score," which is equivalent to a mild reaction”
As I will need to justify my acceptance of this test to use this item on our CE marked products.
How would I do that, are the USP standards a pass/fail type test? Is the test similar enough to reference the ISO to the USP?
Or is their an ISO document or MDD I can use to compare the results.
Thanks
Don