IEC 82304-1: Health software Std Released

“IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved and released. It can be purchased from the ISO at the link provided. This standard addresses Health Software Products in general and does not attempt to define which are regulated and which are not. Its scope is all standalone software not intended to become part of specific hardware designed for its medical use. It refers to IEC 62304 in many places as a normative reference and separately mentions IEC 62366 for Usability. The primary focus of this standard is on requirements for the developers, installers and maintainers of the software product. It is intended to be used alongside IEC 62304 and to cover aspects of the software product that are not covered in IEC 62304, such as accompanying documentation and software validation.

ISO – IEC 82304-1:2016

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