This document outlines proper microbiological methods for obtaining data necessary to control the manufacture and sterilization of medical devices. Subjects addressed in this document include the sampling of devices, the concept of sample item portion (SIP), media preparation, bioburden methods, sterility test methods for validation, validation of bioburden and sterility test methods, and environmental control and monitoring.
AAMI TIR 8-91
Original price was: $184.00.$92.00Current price is: $92.00.
Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
Association for the Advancement of Medical Instrumentation , 07/01/1991
Related products
-
AAMI TIR34971:2023
Original price was: $226.00.$113.00Current price is: $113.00. -
AAMI TIR106:2024
Original price was: $226.00.$113.00Current price is: $113.00. -
AAMI HA60601-1-11:2015/A1:2021
Original price was: $129.00.$64.00Current price is: $64.00. -
AAMI TIR102:2019
Original price was: $319.00.$159.00Current price is: $159.00. -
AAMI HA60601-1-11:2015 & A1:2021
Original price was: $285.00.$142.00Current price is: $142.00.