| name | regulatory-citations |
| description | Cite regulatory standards (IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 81001-5-1) correctly in this repo. Use when writing or reviewing an ADR, a software_development_file/ document, code comments, or any text that claims alignment with a standard clause — covers the citation-key format, the Justification JSON object, and the no-reproduction rule. |
Regulatory citations
The authoritative convention is docs/governance/citation-convention.md; this skill is the
operational recipe. The linter (cargo run --locked -q -p trustsc-docs-lint -- check) enforces it in
CI — run it after any edit under docs/ or software_development_file/.
Navigation recipe
- Identify the standard: software lifecycle →
docs/iec62304/, QMS → docs/iso13485/,
risk management → docs/iso14971/, usability → docs/iec62366/, cybersecurity →
docs/iec81001/.
- Open that folder's
README.md — its Modules table maps clause ranges to NN-*.md files.
- Use the folder's
AI-Reference.md for fast one-row-per-clause lookup, then open the linked
module for the explanatory prose and TrustSC cross-references.
Citation key format
One canonical string per clause, reused verbatim everywhere (module heading, AI-Reference row,
clause_ref field):
<Standard> §<clause>[.<subclause>] <Short clause title>
Example: IEC 62304:2006 §5.2 Software development planning
Only these five standard identifiers are valid (edition year included, exactly):
IEC 62304:2006, ISO 13485:2016, ISO 14971:2019, IEC 62366-1:2015, IEC 81001-5-1:2021.
Caveats:
- IEC 62304 amendment content (AMD1:2015) is noted in prose, never in the key.
- IEC 81001-5-1 clause numbering in this corpus is provisional — read the caveat at the top of
docs/iec81001/README.md before citing it.
The Justification object
When a design decision needs a formal link to a clause, emit a fenced json block conforming to
docs/iec62304/schemas/justification.schema.json (one schema shared by all five standards):
{
"justification_id": "JUS-NNN",
"standard": "IEC 62304",
"clause_ref": "IEC 62304:2006 §5.3.3 Identify segregation necessary for risk control",
"rationale": "Original prose: why/how TrustSC's design addresses this clause.",
"requirement_id": "REQ-... (optional, a real trustsc-governance RequirementId)",
"evidence_refs": ["docs/adr/ADR-005-....md", "crates/trustsc-core/src/lib.rs"]
}
justification_id is JUS-NNN, sequential and unique across the whole corpus — grep
docs/ and software_development_file/ for the highest existing JUS- number before
allocating a new one.standard is one of: IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 81001-5-1
(no edition year here), and must match the clause_ref prefix.evidence_refs entries are real repo paths (files, ADRs, example directories) — the linter
checks they exist.
Worked examples: software_development_file/regulatory/IEC_62304/SAD.md.
Hard rules
- Never reproduce or closely paraphrase a standard's normative text. IEC/ISO standards are
copyrighted commercial documents. The corpus is original explanatory prose written against
clause numbers/titles only. If you need the normative wording, cite the clause and tell the
reader to consult their licensed copy.
- Verify clause numbers against the standard's
AI-Reference.md, never assume them from memory
or other sources.
- Point rationales at concrete TrustSC mechanisms (a governance type, an ADR, a validation in
ComplianceProgram::validate()), not at generic compliance language.
