
Sterilization Of Medical Devices - Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process
出版:Association for Advancement of Medical Instrumentation

专家解读视频
Describes the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing.
Supersedes AAMI TIR 8. (04/2004)
ISO 11737-2 : 2009(R2015) - Identical