316 stainless
316 stainless
(OP)
Hello all,
Can anyone tell me what the difference is between "regular" 316/316L stainless, and "implantable grade" 316/316L?
Is this just a marketing ploy by the steel companies, or is there some discernable difference (i.e. - tighter composition tolerances, clean room handling, lower contaminant requirements, etc)
thanks for any help
Ryan
Lifecor Inc
Pittsburgh, PA
Can anyone tell me what the difference is between "regular" 316/316L stainless, and "implantable grade" 316/316L?
Is this just a marketing ploy by the steel companies, or is there some discernable difference (i.e. - tighter composition tolerances, clean room handling, lower contaminant requirements, etc)
thanks for any help
Ryan
Lifecor Inc
Pittsburgh, PA





RE: 316 stainless
So it's not just a question of the controls involved in production (GMP) but whether approval has being sought or not.
I have seen materials which are approved for 'skin contact' but not approved for implantation. The clinical trials involved for implantation are obviously much more involved.
Check out ISO 10993.
Hope this is of some help.
Cheers,
Speedy
RE: 316 stainless
erwin- aussie chem eng
RE: 316 stainless
RE: 316 stainless
As ETY pointed out this designation of stainless is not used much in implants anymore, the major medical MFG's have developed more stable and stronger variants that are proprietary to each manufacturer.