IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.2.2: 5.2.2 Software requirements content

As suits the software, the requirements cover: function and capability (performance, physical characteristics, computing environment, compatibility with upgrades and with SOUP versions); inputs and outputs of the software system (characteristics of data, ranges, limits and defaults); interfaces to other systems; alarms, warnings and messages to the operator generated by software; security (protection of sensitive information against compromise, authentication, authorization, audit trails, integrity of communication, protection against malware); usability engineering requirements where human error could matter; data definitions and database requirements; installation and acceptance at the site of operation; how the software is operated and maintained; IT-network aspects (alarms over networks, protocols, loss of network services); maintenance done by users; and regulatory requirements. They may overlap and need not all be known at the outset. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

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Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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