AAMI TIR19
Guidance for ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ANSI/AAMI ST 72
Bacterial endotoxin – Test methodologies, routine monitoring and alternatives to batch testing
ANSI/AAMI/ISO 11737-2
Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 10993-7
Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 11737-1
Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
ISO 11737-3
Sterilization of medical devices – Microbiological methods – Part 3: Guidance on evaluation and interpretation of bioburden data
TIR19A1
1999 Amendment to Guidance for ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
USP<1211>
Sterilization and Sterility Assurance of Compendial Articles
USP<161>
Transfusion and Infusion Assemblies and Similar Medical Devices
USP<51>
Antimicrobial Effectiveness Testing
USP<61>
Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
USP<62>
Microbiological Examination of Nonsterile Products: Test for Specified Microorganisms
USP<71>
Sterility Tests
USP<85>
Bacterial Endotoxins Test
