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Covers devices used to treat water intended for use in the delivery of hemodialysis. Included in the scope of the standard is water used for: (1) the preparation of concentrates from powder at a dialysis facility, (2) the preparation of dialysate, and (3) the reprocessing of dialyzers for multiple use.
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