Maximal limit of Aluminum in Polymer Medical Device Implants (EU)

jan.stepanek · Mar 11, 2015

Dear All,

I would like to please you about advice where (in which document) I can find a maximal limit of Aluminum in polymer medical device implants. I mean EU market and EU regulation.

Thanks a lot Jan

Pads38 · Mar 12, 2015

Hi Jan,

I cannot give you a direct answer, but the standards organisation ISO has a number of standards relating to implants. These cover both the base materials and the finished implant itself. You may be able to find something there.

See:-
http://www.iso.org/iso/home/store/catalogue_ics/catalogue_ics_browse.htm?ICS1=11&ICS2=40&ICS3=40

Maximal limit of Aluminum in Polymer Medical Device Implants (EU)

jan.stepanek

Pads38