1979 “AAMI 60Co Dose Setting Intercompany Studies” – The Beginnings of Method 2 of ISO 11137-2
John Kowalski recently posted an item on LinkedIn that provided some valuable and interesting historic information about the first White Paper on the 1979 “AAMI 60Co Dose Setting Intercompany Studies”, protocols and results of the three study phases of these studies.
The original documents show calculations that were made to determine an estimated sterilization dose, at a sterility assurance level (SAL) of 10^-6, based on the results of the microbiological testing of the irradiated inoculated control (IC) samples. The approach used in these calculations shows the beginnings of the development of Method 2 of ISO 11137-2.
John has published a copy of the White Paper under the SteriPro (Advanced Consulting Services) banner. Links to John’s LinkedIn posting and the White Paper appear below.