AAMI Products
ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) (PDF)
Member Price: $175
Non-Member Price: $308
This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE. This standard describes PROCESSES that are intended to be applied to software which executes on a processor or which is executed by other software (for example an interpreter) which executes on a processor.
Date of Publication: 7 April 2016
Pages: 98
ISBN: 978-1-57020-704-4