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 5.3.5: 5.3.5 Identify segregation necessary for risk control

Where risk control requires software items to be kept apart, that segregation is identified, together with an explanation of how it is made effective, for example by running items on separate processors that share no resources, or by other means that the architecture design shows to be effective. Applies to class C.

Maintained by Gerard BlokdykControl text last updated

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.