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ANSI/AAMI/ISO TIR19218-2:2012 (ANSI/AAMI/ISO TIR 19218-2:2012)
Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
Partial revision of ANSI/AAMI/ISO TIR19218:2005.Specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities.
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Association for the Advancement of Medical Instrumentation [aami]