vs-report-iec62304

Disclaimer: Unofficial IEC 62304 traceability helper; not an official IEC product. "IEC 62304" is referenced for interoperability only; this crate is neither endorsed nor certified by the IEC.

IEC 62304 software safety traceability matrix generator for the Craton Shield automotive/medical cybersecurity platform.

Overview

IEC 62304 defines the lifecycle requirements for medical device software and is increasingly referenced in automotive safety standards. A key obligation is software traceability: every software requirement must be linked to verification activities (unit tests, integration tests, static analysis, etc.) whose rigour depends on the software safety classification (Class A, B, or C).

This crate provides a fully no_std, zero-allocation engine that:

• Models software modules, requirements, test cases, and trace links.
• Automatically determines coverage status per requirement.
• Identifies compliance gaps based on the IEC 62304 safety class rules.
• Produces a TraceabilityReport summarising coverage, gaps, and pass/fail status.

Safety classifications

Evidence semantics: failing tests do not count

Under IEC 62304, only passing test executions constitute verification evidence. A linked test case whose passed field is false is treated as absent for coverage classification:

• A failing test does not satisfy the verification method it nominally targets (a failing UnitTest row never makes a requirement count as unit-tested).
• A requirement whose only linked tests have passed == false is reported as TraceStatus::NotCovered, not FullyCovered.
• The corresponding compliance gap is still recorded so the failure is surfaced rather than silently swept into PartiallyCovered.

The trace link's test_ids list still records every linked test (passing and failing) so reviewers can see what verification was attempted; only the status field hides failures.

Quick start

use vs_report_iec62304::{
    TraceabilityInput, SoftwareModule, SoftwareRequirement, TestCase,
    generate_traceability,
};
use vs_report_iec62304::classification::{
    SafetyClass, LifecyclePhase, LifecycleProcess, VerificationMethod,
    RequirementCategory,
};

// 1. Populate a TraceabilityInput with modules, requirements, and test cases.
// 2. Call generate_traceability(&input, generated_at) to obtain an
//    Evidence<TraceabilityReport> envelope.
// 3. Inspect env.payload().is_compliant() and env.payload().coverage_percent().
// 4. Use env.payload().entries() / .gaps() for the valid prefix slices (no
//    ghost rows from the fixed-capacity backing arrays).
// 5. Drive per-module lifecycle moves with LifecycleProcess::transition_to,
//    which rejects illegal phase jumps per IEC 62304 clauses 5-9.

Design constraints

• #![no_std] and #![forbid(unsafe_code)] -- suitable for embedded targets.
• Zero heap allocations -- all data structures use fixed-size arrays on the stack.
• Dependencies: vs-types (shared VsError) and vs-evidence-envelope (provenance metadata wrapper).

License

Apache-2.0. See LICENSE.