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Describes a method of selecting a sterilization dose to be used for radiation sterilization of a single production batch of health care products. It is intended to be used in conjunction with the requirements contained in ANSI/AAMI/ISO 11137 concerning the manufacture and control of products intended for radiation sterilization.
Standard for medical device security—Security risk management for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 12/21/2022
Guidance on the use of agile practices in the development of medical device softwarestandard by Association for the Advancement of...
Water for the processing of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/17/2023
Application of ISO 14971 to machine learning in artificial intelligence—Guidestandard by Association for the Advancement of Medical Instrumentation, 03/14/2023