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AAMI CR513   2024  History   Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing 40 $
AAMI TIR28   2024  History   Product adoption and process equivalence for ethylene oxide sterilization 40 $
AAMI TIR48   2024  History   Quality Management System (QMS) Recommendations on the Application of the U.S. FDA___s CGMP Final Rule on Combination Products 40 $
AAMI TIR99   2024  History   Processing of dilators, transesophageal and ultrasound probes in health care facil ities 40 $
AAMI TIR106   2024  History   Microbiological methodsùUnderstanding and use of product bioburden data 40 $
AAMI ST24   2024  History   Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities 40 $
AAMI 11140-6   2024  History   Steril ization of health care productsù Chemical indicatorsùPart 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers 40 $
AAMI TIR34971   2023  History   Application of ISO 14971 to machine learning in artificial intelligenceùGuide 40 $
AAMI TIR57   2023  History   Principles for medical device securityùRisk management 40 $
AAMI TIR63   2023  History   Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection 40 $