# Common base Audit checklist for IEC62304 Class c products
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# This checklist is not a substitute for reading, understanding, and implementing the associated standard.
# The descriptive phrase following each keyword reference is intended only as a helpful mnemonic for locating
# and recalling the referenced section of the standard.
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include 62304_base_class_b
62304:5.1.4.a Software Development Standards Methods, and Tools Planning: standards
62304:5.1.4.b Software Development Standards Methods, and Tools Planning: methods
62304:5.1.4.c Software Development Standards Methods, and Tools Planning: tools
62304:5.3.5 Identify segregation necessary for risk control
62304:5.4.2 Develop detailed design for each software unit
62304:5.4.3 Develope detailed design for interfaces
62304:5.4.4.a Verify detailed design: implements software architecture
62304:5.4.4.b Verify detailed design: does not contradict software architecture
62304:5.5.4.a Additional Software Unit Acceptance Criteria: proper event sequence
62304:5.5.4.b Additional Software Unit Acceptance Criteria: data and control flow
62304:5.5.4.c Additional Software Unit Acceptance Criteria: planned resource allocation
62304:5.5.4.d Additional Software Unit Acceptance Criteria: fault handling
62304:5.5.4.e Additional Software Unit Acceptance Criteria: initialization of variables
62304:5.5.4.f Additional Software Unit Acceptance Criteria: self-diagnostics
62304:5.5.4.g Additional Software Unit Acceptance Criteria: memory management and memory overflows
62304:5.5.4.h Additional Software Unit Acceptance Criteria: boundary conditions
