biocompatibility of medical devices iso 10993 - Hermon Labs

EXTRACT PREPARATION
The extraction vehicles and conditions of extraction used shall
be appropriate to the nature and use of the final product and to
the purpose of the test
a) (37 ± 1) °C for (72 ± 2) h;
b) (50 ± 2) °C for (72 ± 2) h;
c) (70 ± 2) °C for (24 ± 2) h;
d) (121 ± 2) °C for (1 ± 0,1) h.
The increased temperature may cause cross-linking and/or
polymerization of the polymer and, therefore, decrease the amount of
free monomer that is available to migrate from the polymer
The increased temperature could cause degradation products to form
that are not typically found in the finished device under conditions of
use
Harlan Laboratories 17