IEC 62304 Software Safety Classes¶

IEC 62304 defines three software safety classes (A, B, C) for the medical-device software lifecycle, ranked by the severity of the harm a failure could cause. adacovex assesses compliance against all three by re-labelling the same four evidence checks it computes for DO-178C: HLR traceability, no orphan tags, passing tests, and a minimum SPARK proof level.

Level Definitions¶

Class	Severity	Possible Consequence	Example
C	Highest	Death or serious injury possible	Infusion-pump dosing, radiation-therapy control
B	Moderate	Non-serious injury possible	Diagnostic imaging, patient-monitor alarm logic
A	Lowest	No injury or damage to health	Administrative/scheduling software, data logging

Assessment Criteria¶

adacovex evaluates the same four criteria for every class; only the class name and the minimum proof bar change.

1. HLR Traceability¶

Class	Requirement
A–C	All high-level requirements (HLRs) traced to source-code tags (`-- HLR-XXXX`)

2. Orphan Tags¶

Class	Requirement
A–C	Every in-source HLR tag must correspond to a defined HLR in `compliance/HLR.md`

3. Test Pass/Fail¶

Class	Requirement
A–C	100% tests passing

4. Minimum SPARK Level¶

Class	Minimum SPARK Level
C	Gold
B	Silver
A	Bronze

Mapping to the shared rigor tier¶

IEC 62304 safety classes map onto the same A–E rigor tier DO-178C uses, so one assessment satisfies both standards at once:

Class	Shared tier	DO-178C equivalent
C	A	DAL-A
B	B	DAL-B
A	C	DAL-C

CLI selection¶

adacovex --target=. --class=A          # assess at safety Class A
adacovex --target=. --class=C          # assess at safety Class C (requires Gold SPARK)
adacovex --target=. --standard=iec62304 --dal=C   # Class A via the shared tier
adacovex --target=. --standard=all     # badges for DO-178C + ISO 26262 + IEC 62304

See Standards for the full cross-standard tier mapping, DAL Levels for the DO-178C criteria this page generalizes, and SPARK Levels for the per-level proof bar.

Assessment Output¶

The tool reports each criterion as met/unmet and a final Achieved/Unmet status, labelled with the safety-class name:

Target level: Class A
Status: Achieved
HLR traced:  24 /  24
Orphan tags: No
Tests passing: Yes
Min SPARK level met: Yes