AAMI Working Group 2 on Radiation Sterilization just published a new Technical Information Report (TIR) 40:2009, entitled Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2. A typical Method 2A or 2B validation entails testing of 60 samples each at either 9 or 8 different doses. This new TIR provides guidance on how to reduce the quantity of doses from 9 or 8 down to 3 or 4, if the correct data are obtained from those doses.

The document can be purchased from the AAMI website at www.AAMI.org. Additional information can be obtained by contacting our Nelson radiation experts, Wendy Wangsgard at wwangsgard@nelsonlabs.com or Martell Winters at mwinters@nelsonlabs.com.