@memoarchitect/ontology 0.7.0 → 0.8.22

package/src/artifacts/standards/iec_62304.sysml

@@ -0,0 +1,210 @@
+// IEC 62304:2006+AMD1:2015 — medical device software lifecycle processes.
+//
+// Clause instances, not type machinery. Everything here is data: adding a
+// standard is one file like this one and zero TypeScript changes.
+//
+// Depth is representative, not exhaustive — the level at which the standard
+// makes a distinct normative requirement a MEMO document actually claims.
+// A clause nobody claims yet costs nothing to add later.
+//
+// Each `title` is a MEMO-AUTHORED scope phrase, never the standard's own
+// normative wording, which is copyrighted. It is a display label: queries
+// traverse ConformsTo to the clause instance, they never match on its text.
+package memo_artifacts_standards_iec_62304 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec62304 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-62304";
+        attribute :>> name = "IEC62304";
+        attribute :>> designation = "IEC 62304:2006+AMD1:2015";
+        attribute :>> edition = "2006";
+        attribute :>> issuer = "IEC";
+        attribute :>> amendments = "AMD1:2015";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    // ── 4 General requirements ───────────────────────────────────────────
+    item iec62304Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-4";
+        attribute :>> name = "IEC62304Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general lifecycle prerequisites";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause4_3 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-4-3";
+        attribute :>> name = "IEC62304Clause4_3";
+        attribute :>> clauseNumber = "4.3";
+        attribute :>> title = "software safety classification";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    // ── 5 Software development process ───────────────────────────────────
+    item iec62304Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5";
+        attribute :>> name = "IEC62304Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "software development process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_1 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-1";
+        attribute :>> name = "IEC62304Clause5_1";
+        attribute :>> clauseNumber = "5.1";
+        attribute :>> title = "software development planning";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_1_1 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-1-1";
+        attribute :>> name = "IEC62304Clause5_1_1";
+        attribute :>> clauseNumber = "5.1.1";
+        attribute :>> title = "software development plan";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_2 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-2";
+        attribute :>> name = "IEC62304Clause5_2";
+        attribute :>> clauseNumber = "5.2";
+        attribute :>> title = "software requirements analysis";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_2_2 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-2-2";
+        attribute :>> name = "IEC62304Clause5_2_2";
+        attribute :>> clauseNumber = "5.2.2";
+        attribute :>> title = "software requirements content";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_2_3 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-2-3";
+        attribute :>> name = "IEC62304Clause5_2_3";
+        attribute :>> clauseNumber = "5.2.3";
+        attribute :>> title = "risk control measures carried into software requirements";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_2_6 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-2-6";
+        attribute :>> name = "IEC62304Clause5_2_6";
+        attribute :>> clauseNumber = "5.2.6";
+        attribute :>> title = "software requirements verification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_3 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-3";
+        attribute :>> name = "IEC62304Clause5_3";
+        attribute :>> clauseNumber = "5.3";
+        attribute :>> title = "software architectural design";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_4 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-4";
+        attribute :>> name = "IEC62304Clause5_4";
+        attribute :>> clauseNumber = "5.4";
+        attribute :>> title = "software detailed design";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_5 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-5";
+        attribute :>> name = "IEC62304Clause5_5";
+        attribute :>> clauseNumber = "5.5";
+        attribute :>> title = "software unit implementation and verification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_6 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-6";
+        attribute :>> name = "IEC62304Clause5_6";
+        attribute :>> clauseNumber = "5.6";
+        attribute :>> title = "software integration and integration testing";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_7 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-7";
+        attribute :>> name = "IEC62304Clause5_7";
+        attribute :>> clauseNumber = "5.7";
+        attribute :>> title = "software system testing";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_7_5 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-7-5";
+        attribute :>> name = "IEC62304Clause5_7_5";
+        attribute :>> clauseNumber = "5.7.5";
+        attribute :>> title = "software system test records";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause5_8 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-5-8";
+        attribute :>> name = "IEC62304Clause5_8";
+        attribute :>> clauseNumber = "5.8";
+        attribute :>> title = "software release";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    // ── 6-9 Supporting processes ─────────────────────────────────────────
+    item iec62304Clause6 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-6";
+        attribute :>> name = "IEC62304Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> title = "software maintenance process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause7 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-7";
+        attribute :>> name = "IEC62304Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "software risk management process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause8 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-8";
+        attribute :>> name = "IEC62304Clause8";
+        attribute :>> clauseNumber = "8";
+        attribute :>> title = "software configuration management process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause8_1_2 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-8-1-2";
+        attribute :>> name = "IEC62304Clause8_1_2";
+        attribute :>> clauseNumber = "8.1.2";
+        attribute :>> title = "SOUP identification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62304Clause9 : StandardClause {
+        attribute :>> id = "STD-IEC-62304-9";
+        attribute :>> name = "IEC62304Clause9";
+        attribute :>> clauseNumber = "9";
+        attribute :>> title = "software problem resolution process";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    // ── Containment ──────────────────────────────────────────────────────
+    // The existing Composes relation, standard → clause → sub-clause. There
+    // is no clause-specific composition type: whole/part decomposition is
+    // already one relation in MEMO.
+    connection iec62304Has4 : Composes connect parent ::> iec62304 to child ::> iec62304Clause4;
+    connection iec62304Has5 : Composes connect parent ::> iec62304 to child ::> iec62304Clause5;
+    connection iec62304Has6 : Composes connect parent ::> iec62304 to child ::> iec62304Clause6;
+    connection iec62304Has7 : Composes connect parent ::> iec62304 to child ::> iec62304Clause7;
+    connection iec62304Has8 : Composes connect parent ::> iec62304 to child ::> iec62304Clause8;
+    connection iec62304Has9 : Composes connect parent ::> iec62304 to child ::> iec62304Clause9;
+
+    connection iec62304Has4_3 : Composes connect parent ::> iec62304Clause4 to child ::> iec62304Clause4_3;
+
+    connection iec62304Has5_1 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_1;
+    connection iec62304Has5_2 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_2;
+    connection iec62304Has5_3 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_3;
+    connection iec62304Has5_4 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_4;
+    connection iec62304Has5_5 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_5;
+    connection iec62304Has5_6 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_6;
+    connection iec62304Has5_7 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_7;
+    connection iec62304Has5_8 : Composes connect parent ::> iec62304Clause5 to child ::> iec62304Clause5_8;
+
+    connection iec62304Has5_1_1 : Composes connect parent ::> iec62304Clause5_1 to child ::> iec62304Clause5_1_1;
+    connection iec62304Has5_2_2 : Composes connect parent ::> iec62304Clause5_2 to child ::> iec62304Clause5_2_2;
+    connection iec62304Has5_2_3 : Composes connect parent ::> iec62304Clause5_2 to child ::> iec62304Clause5_2_3;
+    connection iec62304Has5_2_6 : Composes connect parent ::> iec62304Clause5_2 to child ::> iec62304Clause5_2_6;
+    connection iec62304Has5_7_5 : Composes connect parent ::> iec62304Clause5_7 to child ::> iec62304Clause5_7_5;
+    connection iec62304Has8_1_2 : Composes connect parent ::> iec62304Clause8 to child ::> iec62304Clause8_1_2;
+}

package/src/artifacts/standards/iec_62366_1.sysml

@@ -0,0 +1,113 @@
+// IEC 62366-1:2015+AMD1:2020 — application of usability engineering to
+// medical devices.
+//
+// The amendment is carried in the designation: dropping it is a CE/MDR
+// regression. `title` is a MEMO-AUTHORED scope phrase, never the standard's
+// own normative wording.
+package memo_artifacts_standards_iec_62366_1 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec62366_1 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-62366-1";
+        attribute :>> name = "IEC62366_1";
+        attribute :>> designation = "IEC 62366-1:2015+AMD1:2020";
+        attribute :>> edition = "2015";
+        attribute :>> issuer = "IEC";
+        attribute :>> amendments = "AMD1:2020";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iec62366_1Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-4";
+        attribute :>> name = "IEC62366_1Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements for the usability engineering process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5";
+        attribute :>> name = "IEC62366_1Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "usability engineering process";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_1 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-1";
+        attribute :>> name = "IEC62366_1Clause5_1";
+        attribute :>> clauseNumber = "5.1";
+        attribute :>> title = "use specification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_2 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-2";
+        attribute :>> name = "IEC62366_1Clause5_2";
+        attribute :>> clauseNumber = "5.2";
+        attribute :>> title = "user interface characteristics related to safety";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_3 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-3";
+        attribute :>> name = "IEC62366_1Clause5_3";
+        attribute :>> clauseNumber = "5.3";
+        attribute :>> title = "known and foreseeable use-related hazards";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_4 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-4";
+        attribute :>> name = "IEC62366_1Clause5_4";
+        attribute :>> clauseNumber = "5.4";
+        attribute :>> title = "hazard-related use scenarios";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_5 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-5";
+        attribute :>> name = "IEC62366_1Clause5_5";
+        attribute :>> clauseNumber = "5.5";
+        attribute :>> title = "selection of use scenarios for summative evaluation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_6 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-6";
+        attribute :>> name = "IEC62366_1Clause5_6";
+        attribute :>> clauseNumber = "5.6";
+        attribute :>> title = "user interface specification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_7 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-7";
+        attribute :>> name = "IEC62366_1Clause5_7";
+        attribute :>> clauseNumber = "5.7";
+        attribute :>> title = "user interface evaluation plan";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_8 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-8";
+        attribute :>> name = "IEC62366_1Clause5_8";
+        attribute :>> clauseNumber = "5.8";
+        attribute :>> title = "user interface design and formative evaluation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec62366_1Clause5_9 : StandardClause {
+        attribute :>> id = "STD-IEC-62366-1-5-9";
+        attribute :>> name = "IEC62366_1Clause5_9";
+        attribute :>> clauseNumber = "5.9";
+        attribute :>> title = "summative evaluation of the user interface";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec62366_1Has4 : Composes connect parent ::> iec62366_1 to child ::> iec62366_1Clause4;
+    connection iec62366_1Has5 : Composes connect parent ::> iec62366_1 to child ::> iec62366_1Clause5;
+
+    connection iec62366_1Has5_1 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_1;
+    connection iec62366_1Has5_2 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_2;
+    connection iec62366_1Has5_3 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_3;
+    connection iec62366_1Has5_4 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_4;
+    connection iec62366_1Has5_5 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_5;
+    connection iec62366_1Has5_6 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_6;
+    connection iec62366_1Has5_7 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_7;
+    connection iec62366_1Has5_8 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_8;
+    connection iec62366_1Has5_9 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_9;
+}

package/src/artifacts/standards/iec_81001_5_1.sysml

@@ -0,0 +1,84 @@
+// IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
+//
+// Clause instances, not type machinery. Everything here is data: adding a
+// standard is one file like this one and zero TypeScript changes.
+package memo_artifacts_standards_iec_81001_5_1 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec81001_5_1 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-81001-5-1";
+        attribute :>> name = "IEC81001_5_1";
+        attribute :>> designation = "IEC 81001-5-1:2021";
+        attribute :>> edition = "2021";
+        attribute :>> issuer = "IEC";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iec81001_5_1Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-4";
+        attribute :>> name = "IEC81001_5_1Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5";
+        attribute :>> name = "IEC81001_5_1Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "software development process";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_1 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-1";
+        attribute :>> name = "IEC81001_5_1Clause5_1";
+        attribute :>> clauseNumber = "5.1";
+        attribute :>> title = "software development planning";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_2 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-2";
+        attribute :>> name = "IEC81001_5_1Clause5_2";
+        attribute :>> clauseNumber = "5.2";
+        attribute :>> title = "software requirements analysis";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_3 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-3";
+        attribute :>> name = "IEC81001_5_1Clause5_3";
+        attribute :>> clauseNumber = "5.3";
+        attribute :>> title = "software architectural design";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_4 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-4";
+        attribute :>> name = "IEC81001_5_1Clause5_4";
+        attribute :>> clauseNumber = "5.4";
+        attribute :>> title = "software design";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    item iec81001_5_1Clause5_8 : StandardClause {
+        attribute :>> id = "STD-IEC-81001-5-1-5-8";
+        attribute :>> name = "IEC81001_5_1Clause5_8";
+        attribute :>> clauseNumber = "5.8";
+        attribute :>> title = "software release";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec81001_5_1Has4 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause4;
+    connection iec81001_5_1Has5 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause5;
+    
+    connection iec81001_5_1Has5_1 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_1;
+    connection iec81001_5_1Has5_2 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_2;
+    connection iec81001_5_1Has5_3 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_3;
+    connection iec81001_5_1Has5_4 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_4;
+    connection iec81001_5_1Has5_8 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_8;
+}

package/src/artifacts/standards/iso_13485.sysml

@@ -0,0 +1,113 @@
+// ISO 13485:2016 — quality management systems for medical devices.
+//
+// Only the design-and-development and document-control clauses MEMO documents
+// actually claim are represented. The rest of the QMS is a management-system
+// concern that no model element traces to, and an unclaimed clause costs
+// nothing to add later.
+package memo_artifacts_standards_iso_13485 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iso13485 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-13485";
+        attribute :>> name = "ISO13485";
+        attribute :>> designation = "ISO 13485:2016";
+        attribute :>> edition = "2016";
+        attribute :>> issuer = "ISO";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
+    }
+
+    item iso13485Clause4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4";
+        attribute :>> name = "ISO13485Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "quality management system";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause4_2 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4-2";
+        attribute :>> name = "ISO13485Clause4_2";
+        attribute :>> clauseNumber = "4.2";
+        attribute :>> title = "quality management system documentation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause4_2_4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-4-2-4";
+        attribute :>> name = "ISO13485Clause4_2_4";
+        attribute :>> clauseNumber = "4.2.4";
+        attribute :>> title = "control of documents";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7";
+        attribute :>> name = "ISO13485Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "product realization";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3";
+        attribute :>> name = "ISO13485Clause7_3";
+        attribute :>> clauseNumber = "7.3";
+        attribute :>> title = "design and development";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_3 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-3";
+        attribute :>> name = "ISO13485Clause7_3_3";
+        attribute :>> clauseNumber = "7.3.3";
+        attribute :>> title = "design and development inputs";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_4 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-4";
+        attribute :>> name = "ISO13485Clause7_3_4";
+        attribute :>> clauseNumber = "7.3.4";
+        attribute :>> title = "design and development outputs";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_6 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-6";
+        attribute :>> name = "ISO13485Clause7_3_6";
+        attribute :>> clauseNumber = "7.3.6";
+        attribute :>> title = "design and development verification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_7 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-7";
+        attribute :>> name = "ISO13485Clause7_3_7";
+        attribute :>> clauseNumber = "7.3.7";
+        attribute :>> title = "design and development validation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_9 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-9";
+        attribute :>> name = "ISO13485Clause7_3_9";
+        attribute :>> clauseNumber = "7.3.9";
+        attribute :>> title = "control of design and development changes";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso13485Clause7_3_10 : StandardClause {
+        attribute :>> id = "STD-ISO-13485-7-3-10";
+        attribute :>> name = "ISO13485Clause7_3_10";
+        attribute :>> clauseNumber = "7.3.10";
+        attribute :>> title = "design and development files";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iso13485Has4 : Composes connect parent ::> iso13485 to child ::> iso13485Clause4;
+    connection iso13485Has7 : Composes connect parent ::> iso13485 to child ::> iso13485Clause7;
+
+    connection iso13485Has4_2 : Composes connect parent ::> iso13485Clause4 to child ::> iso13485Clause4_2;
+    connection iso13485Has4_2_4 : Composes connect parent ::> iso13485Clause4_2 to child ::> iso13485Clause4_2_4;
+
+    connection iso13485Has7_3 : Composes connect parent ::> iso13485Clause7 to child ::> iso13485Clause7_3;
+    connection iso13485Has7_3_3 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_3;
+    connection iso13485Has7_3_4 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_4;
+    connection iso13485Has7_3_6 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_6;
+    connection iso13485Has7_3_7 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_7;
+    connection iso13485Has7_3_9 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_9;
+    connection iso13485Has7_3_10 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_10;
+}

package/src/artifacts/standards/iso_14971.sysml

@@ -0,0 +1,94 @@
+// ISO 14971:2019 — application of risk management to medical devices.
+//
+// The risk-management process every other pack feeds. `title` is a
+// MEMO-AUTHORED scope phrase, never the standard's own normative wording.
+package memo_artifacts_standards_iso_14971 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iso14971 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-14971";
+        attribute :>> name = "ISO14971";
+        attribute :>> designation = "ISO 14971:2019";
+        attribute :>> edition = "2019";
+        attribute :>> issuer = "ISO";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iso14971Clause4 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4";
+        attribute :>> name = "ISO14971Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements for the risk management system";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause4_4 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4-4";
+        attribute :>> name = "ISO14971Clause4_4";
+        attribute :>> clauseNumber = "4.4";
+        attribute :>> title = "risk management plan";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause4_5 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-4-5";
+        attribute :>> name = "ISO14971Clause4_5";
+        attribute :>> clauseNumber = "4.5";
+        attribute :>> title = "risk management file";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause5 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-5";
+        attribute :>> name = "ISO14971Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "risk analysis";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause6 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-6";
+        attribute :>> name = "ISO14971Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> title = "risk evaluation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause7 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-7";
+        attribute :>> name = "ISO14971Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "risk control";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause8 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-8";
+        attribute :>> name = "ISO14971Clause8";
+        attribute :>> clauseNumber = "8";
+        attribute :>> title = "evaluation of overall residual risk";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause9 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-9";
+        attribute :>> name = "ISO14971Clause9";
+        attribute :>> clauseNumber = "9";
+        attribute :>> title = "risk management review";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iso14971Clause10 : StandardClause {
+        attribute :>> id = "STD-ISO-14971-10";
+        attribute :>> name = "ISO14971Clause10";
+        attribute :>> clauseNumber = "10";
+        attribute :>> title = "production and post-production activities";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iso14971Has4 : Composes connect parent ::> iso14971 to child ::> iso14971Clause4;
+    connection iso14971Has5 : Composes connect parent ::> iso14971 to child ::> iso14971Clause5;
+    connection iso14971Has6 : Composes connect parent ::> iso14971 to child ::> iso14971Clause6;
+    connection iso14971Has7 : Composes connect parent ::> iso14971 to child ::> iso14971Clause7;
+    connection iso14971Has8 : Composes connect parent ::> iso14971 to child ::> iso14971Clause8;
+    connection iso14971Has9 : Composes connect parent ::> iso14971 to child ::> iso14971Clause9;
+    connection iso14971Has10 : Composes connect parent ::> iso14971 to child ::> iso14971Clause10;
+
+    connection iso14971Has4_4 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_4;
+    connection iso14971Has4_5 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_5;
+}

package/src/artifacts/standards/iso_iec_ieee_42010.sysml

@@ -0,0 +1,42 @@
+// ISO/IEC/IEEE 42010:2022 — architecture description.
+//
+// One standard from a joint committee, not three: the spaced slash is what
+// separates two designations, and there is none here.
+//
+// SCOPE PHRASES DELIBERATELY ABSENT — same reason as the IEC 60812 pack. The
+// 2022 edition reorganised the clause structure of 42010:2011, and MEMO has no
+// verified reading of the new numbering. A missing label is a gap a reviewer
+// closes in one line; a guessed one is a citation nobody can check.
+package memo_artifacts_standards_iso_iec_ieee_42010 {
+    private import ScalarValues::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item isoIecIeee42010 : RegulatoryStandard {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010";
+        attribute :>> name = "ISOIECIEEE42010";
+        attribute :>> designation = "ISO/IEC/IEEE 42010:2022";
+        attribute :>> edition = "2022";
+        attribute :>> issuer = "ISO/IEC/IEEE";
+        // No submission regime mandates this standard: it is a method /
+        // reference standard, cited by documents rather than required by a
+        // market. Empty is the authored value, not an omission — see
+        // appliesToRegime in memo_artifacts_standards_traceability.
+    }
+
+    item isoIecIeee42010Clause5 : StandardClause {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010-5";
+        attribute :>> name = "ISOIECIEEE42010Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> normativeStrength = "shall";
+    }
+    item isoIecIeee42010Clause6 : StandardClause {
+        attribute :>> id = "STD-ISO-IEC-IEEE-42010-6";
+        attribute :>> name = "ISOIECIEEE42010Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection isoIecIeee42010Has5 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause5;
+    connection isoIecIeee42010Has6 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause6;
+}