M
Hi Everyone,
We are wanting to submit samples for Biocompatibility testing (ISO 10993), but the colour is slightly off. I'm curious if there's some way to argue equivalence given that the colouring process is identical, albeit with different proportions of CMYK.
For example, suppose you have a blue rubber ISO 10993 tested, and passed. Then, marketing decides the blue should be slightly lighter. Does this then mean that all the biocompatibility tests have to be repeated? Or can it be argued that the colours and dyes are still the same, just mixed in slightly different proportions?
I realize that what is tested should (ideally) be identical to the final product. But it also seems that design changes involving identical materials, just in slightly different quantities, necessitating a complete re-testing is unreasonably onerous.
Any advice or discussion much appreciated.
MM
We are wanting to submit samples for Biocompatibility testing (ISO 10993), but the colour is slightly off. I'm curious if there's some way to argue equivalence given that the colouring process is identical, albeit with different proportions of CMYK.
For example, suppose you have a blue rubber ISO 10993 tested, and passed. Then, marketing decides the blue should be slightly lighter. Does this then mean that all the biocompatibility tests have to be repeated? Or can it be argued that the colours and dyes are still the same, just mixed in slightly different proportions?
I realize that what is tested should (ideally) be identical to the final product. But it also seems that design changes involving identical materials, just in slightly different quantities, necessitating a complete re-testing is unreasonably onerous.
Any advice or discussion much appreciated.
MM