TY - JOUR T1 - A Procedure for Supplementing the AAMI B1 Method for Validating Radiation Sterilized Products JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 126 LP - 127 VL - 41 IS - 4 AU - Thomas F. Genova AU - Robert A. Hollis AU - Curtis A. Crowell AU - Kathleen M. Schady Y1 - 1987/07/01 UR - http://journal.pda.org/content/41/4/126.abstract N2 - A method is described which supplements the AAMI B1 method for validating radiation sterilization of medical devices. The method utilizes AAMI B1 experimental data in conjunction with a set of standard resistance (D) values to calculate process doses in those instances when the AAMI B1 acceptance criteria are not met. ER -