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The Association for the Advancement of Medical Instrumentation

AAMI is dedicated to serving professionals in the medical device industry and is the premier developer of standards relating to safety, performance and marketability of medical instrumentation.

Most Popular Titles From AAMI:

ANSI/AAMI IEC 62304:2006 Medical device software - Software life cycle processes
ANSI/AAMI HE74:2001 Human Factors Design Process for Medical Devices
AAMI TIR28:2009 Product adoption and process equivalency for ethylene oxide sterilization
ANSI/AAMI ST72:2002 Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing
ANSI/AAMI RD62:2006 and RD62:2006/A1:2009 (Consolidated Text) Water treatment equipment for hemodialysis applications
AAMI TIR33:2005 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
ANSI/AAMI ST46-2002 Steam sterilization and sterility assurance in health care facilities
AAMI TIR16:2000 Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects

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