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This document contains only those pages of ST79 that were impacted by Amendment 4. Purchasers can update their copy of the second edition of ST79 (ST79:2010 and Amendments). The changes are shown in redline, with Highlight for new info and Strikethrough for deleted text.
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