A change has occurred in the new version of the AAMI/ISO standard on sterility testing, AAMI/ISO 11737-2, which may impact your current and future testing. The new version of the standard, in the last paragraph of Clause A.6.6, states regarding the Bacteriostasis/Fungistasis (B/F) test:

"....the incubation temperature(s) and medium (media) shall be the same as those to be used in performing tests of sterility."
Historically the sterility testing of irradiated product has usually been performed per the AAMI/ISO standard at 28-32°C, but the B/F test has usually been performed per the USP guidance at 20-25°C. This change in the new version of 11737-2 harmonizes those temperatures.

There is no requirement in the standard that previously performed B/F tests be repeated at the new temperature. However since you may wish to repeat it to be in compliance with the new standard, we will only repeat the B/F tests at the new temperature upon your request.

All new B/F tests for radiation studies will be performed per the new standard, at 28-32°C, unless otherwise requested.

Please email Martell Winters or call 801-290-7864 with any questions or concerns you may have regarding this change.