Not necessarily. The chemical composition conforming to a consensus standard such as ASTM or ISO dictates whether the stainless steel alloy is acceptable for implantation.
However, receiving material certified to the respective standard does not free the end user from having to demonstrate that the material in its final form is still biocompatible.
Hope that helps.
I believe the VM stands for vacuum melted, but both are low carbon versions of type 316 stainless. Here's an article form maybe what you would consider an unlikely source that helps explain the difference (but maybe not the final say) -
thanks for your answer, but I will put the question in an other way:
I have today stainless steel 316L. I can do biological test today on it.
The final product will be based on 316LVM.
Can I avoid the biological test of the 316LVM saying that 316L is "the same" of 316LVM or in such a way worst in terms of purity? (I want save time)
This is your call, but I see it as low risk in terms of actually failing biocomp. However you're going to have to justify why the "standard" type 316L you used is a good surrogate for type 316LVM you intend to use when you lay all your cards on the table in front of a regulatory body. The safest bet would be to get the material you intend on going to market with. This way you don't have to justify anything.
If your application is indeed a long-term implant, then purchase ASTM F138 (or the equivalent ISO). Whatever material you settle on have it either come certified to ASTM F138 or self-cert by comparing the chemistry, mechanical properties, etc. on the COC against the standard.
The technical and biological risk is negligible. Vacuum treatment does nothing to benefit convention AOD refined 36L. However, you'll be hanging out legally if anything adverse, even unrelated, occurs.
I don't think the technical facts are the determining factor.
Since it is the medical field ,shysters (lawyers) could be involved. The critical factor will be what a shyster can convince a jury chosen from the ignorant masses. Use the "standard of industry" = ASTM.
I have been deposed in 3 cases. In one I showed Amoco products has no connection with the failure; Amoco paid a half million. Our attorney said anytime 2 deaths are involved, a payout of only a half million (years ago) , in spite of no fault , is a "win".
