Suppliers of ISO 10993 compliant Material for Skin Contact



Hello Friends,

I am a medical device engineer. I am currently looking for a ISO 10993 approved off the shelf material that fulfills all the test requirements to be used in skin contact for a longer duration. I think Neoprene and Polyisoprene are good options but I am not able to find any manufacturer. I do not want to conduct any required tests (or find some lab that would do it for me) to comply with ISO 10993 medical device standards. I would appreciate if you can suggest me any manufacturer who produce such medical grade neoprene/polyisoprene and whose certification I can use. If you have suggestions regarding any other material I can use, please feel free to suggest.

Any suggestion is welcome.

Kind regards,
Ravi :)