PT  - JOURNAL ARTICLE
AU  - Genova, Thomas F.
AU  - Hollis, Robert A.
AU  - Crowell, Curtis A.
AU  - Schady, Kathleen M.
TI  - A Procedure for Supplementing the AAMI B1 Method for Validating Radiation Sterilized Products
DP  - 1987 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 126--127
VI  - 41
IP  - 4
4099  - http://journal.pda.org/content/41/4/126.short
4100  - http://journal.pda.org/content/41/4/126.full
SO  - PDA J Pharm Sci Technol1987 Jul 01; 41
AB  - 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.