Click here to purchase
This three-book set consists of Biological Evaluation of Medical Devices, 1997 edition (BIOT7) and two supplemental editions published in 1998 and 1999. Combined total of 15 current final standards in the biological evaluation series, with index of all 15 documents included in the 1999 supplement.
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