RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 126
OP 127
VO 41
IS 4
A1 Thomas F. Genova
A1 Robert A. Hollis
A1 Curtis A. Crowell
A1 Kathleen M. Schady
YR 1987
UL http://journal.pda.org/content/41/4/126.abstract
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.