Covers apparatus for preparing dialysate, monitors of the dialysate, and accessories for monitoring the extracorporeal blood circuit. The requirements established by this standard will, at a minimum, help ensure the effective, safe performance of hemodialysis systems, devices, and related materials.
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