@memoarchitect/ontology 0.6.5 → 0.8.22

package/src/artifacts/standards/iec_60601_1.sysml

@@ -0,0 +1,149 @@
+// IEC 60601-1:2005+AMD1:2012+AMD2:2020 — basic safety and essential
+// performance of medical electrical equipment.
+//
+// This pack is the test of whether the standards library generalises past
+// software: 60601-1 is a hardware-and-system standard, so its clauses are
+// claimed by hardware requirements, physical elements and system-level
+// documents rather than by software items.
+//
+// Depth is representative — the clause level, plus the sub-clauses MEMO
+// documents actually claim. `title` is a MEMO-AUTHORED scope phrase, never
+// the standard's own normative wording.
+package memo_artifacts_standards_iec_60601_1 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec60601_1 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-60601-1";
+        attribute :>> name = "IEC60601_1";
+        attribute :>> designation = "IEC 60601-1:2005+AMD1:2012+AMD2:2020";
+        attribute :>> edition = "3.2";
+        attribute :>> issuer = "IEC";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iec60601_1Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-4";
+        attribute :>> name = "IEC60601_1Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements for basic safety and essential performance";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause4_2 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-4-2";
+        attribute :>> name = "IEC60601_1Clause4_2";
+        attribute :>> clauseNumber = "4.2";
+        attribute :>> title = "risk management process for medical electrical equipment";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause4_3 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-4-3";
+        attribute :>> name = "IEC60601_1Clause4_3";
+        attribute :>> clauseNumber = "4.3";
+        attribute :>> title = "essential performance identification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-5";
+        attribute :>> name = "IEC60601_1Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "general requirements for testing";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause7 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-7";
+        attribute :>> name = "IEC60601_1Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "equipment identification, marking and accompanying documents";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause8 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-8";
+        attribute :>> name = "IEC60601_1Clause8";
+        attribute :>> clauseNumber = "8";
+        attribute :>> title = "protection against electrical hazards";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause9 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-9";
+        attribute :>> name = "IEC60601_1Clause9";
+        attribute :>> clauseNumber = "9";
+        attribute :>> title = "protection against mechanical hazards";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause10 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-10";
+        attribute :>> name = "IEC60601_1Clause10";
+        attribute :>> clauseNumber = "10";
+        attribute :>> title = "protection against unwanted and excessive radiation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause11 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-11";
+        attribute :>> name = "IEC60601_1Clause11";
+        attribute :>> clauseNumber = "11";
+        attribute :>> title = "protection against excessive temperatures and related hazards";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause12 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-12";
+        attribute :>> name = "IEC60601_1Clause12";
+        attribute :>> clauseNumber = "12";
+        attribute :>> title = "accuracy of controls and protection against hazardous output";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause13 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-13";
+        attribute :>> name = "IEC60601_1Clause13";
+        attribute :>> clauseNumber = "13";
+        attribute :>> title = "hazardous situations and fault conditions";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause14 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-14";
+        attribute :>> name = "IEC60601_1Clause14";
+        attribute :>> clauseNumber = "14";
+        attribute :>> title = "programmable electrical medical systems";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause15 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-15";
+        attribute :>> name = "IEC60601_1Clause15";
+        attribute :>> clauseNumber = "15";
+        attribute :>> title = "construction of medical electrical equipment";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause16 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-16";
+        attribute :>> name = "IEC60601_1Clause16";
+        attribute :>> clauseNumber = "16";
+        attribute :>> title = "medical electrical systems";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1Clause17 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-17";
+        attribute :>> name = "IEC60601_1Clause17";
+        attribute :>> clauseNumber = "17";
+        attribute :>> title = "electromagnetic compatibility";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec60601_1Has4 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause4;
+    connection iec60601_1Has5 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause5;
+    connection iec60601_1Has7 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause7;
+    connection iec60601_1Has8 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause8;
+    connection iec60601_1Has9 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause9;
+    connection iec60601_1Has10 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause10;
+    connection iec60601_1Has11 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause11;
+    connection iec60601_1Has12 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause12;
+    connection iec60601_1Has13 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause13;
+    connection iec60601_1Has14 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause14;
+    connection iec60601_1Has15 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause15;
+    connection iec60601_1Has16 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause16;
+    connection iec60601_1Has17 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause17;
+
+    connection iec60601_1Has4_2 : Composes connect parent ::> iec60601_1Clause4 to child ::> iec60601_1Clause4_2;
+    connection iec60601_1Has4_3 : Composes connect parent ::> iec60601_1Clause4 to child ::> iec60601_1Clause4_3;
+}

package/src/artifacts/standards/iec_60601_1_2.sysml

@@ -0,0 +1,56 @@
+// IEC 60601-1-2:2014+AMD1:2020 — collateral standard for electromagnetic
+// disturbances.
+//
+// Separate from the 60601-1 pack because it is a separate designation with its
+// own edition and amendment history: a hardware requirement claiming EMC
+// emissions cites this document, not the general standard.
+package memo_artifacts_standards_iec_60601_1_2 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec60601_1_2 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-60601-1-2-COLLATERAL";
+        attribute :>> name = "IEC60601_1_2";
+        attribute :>> designation = "IEC 60601-1-2:2014+AMD1:2020";
+        attribute :>> edition = "4.1";
+        attribute :>> issuer = "IEC";
+        attribute :>> amendments = "AMD1:2020";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item iec60601_1_2Clause4 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-2-4";
+        attribute :>> name = "IEC60601_1_2Clause4";
+        attribute :>> clauseNumber = "4";
+        attribute :>> title = "general requirements for electromagnetic disturbances";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1_2Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-2-5";
+        attribute :>> name = "IEC60601_1_2Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> title = "electromagnetic compatibility information in accompanying documents";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1_2Clause7 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-2-7";
+        attribute :>> name = "IEC60601_1_2Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> title = "electromagnetic emissions";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60601_1_2Clause8 : StandardClause {
+        attribute :>> id = "STD-IEC-60601-1-2-8";
+        attribute :>> name = "IEC60601_1_2Clause8";
+        attribute :>> clauseNumber = "8";
+        attribute :>> title = "electromagnetic immunity";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec60601_1_2Has4 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause4;
+    connection iec60601_1_2Has5 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause5;
+    connection iec60601_1_2Has7 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause7;
+    connection iec60601_1_2Has8 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause8;
+}

package/src/artifacts/standards/iec_60812.sysml

@@ -0,0 +1,51 @@
+// IEC 60812:2018 — failure modes and effects analysis (FMEA and FMECA).
+//
+// The analysis method the FMEA template claims; the risk-management process it
+// feeds is ISO 14971, carried separately in that template's `clauses:`.
+//
+// SCOPE PHRASES DELIBERATELY ABSENT. `title` is optional, and the clauses this
+// pack needs are cited by number in the FMEA template without MEMO having a
+// verified reading of what each one governs in the 2018 edition. An absent
+// label is a visible gap a regulatory reviewer can close in one line; a guessed
+// one is a citation nobody can check. Clause resolution and traceability work
+// either way — the phrase is a display label, never what queries match on.
+package memo_artifacts_standards_iec_60812 {
+    private import ScalarValues::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item iec60812 : RegulatoryStandard {
+        attribute :>> id = "STD-IEC-60812";
+        attribute :>> name = "IEC60812";
+        attribute :>> designation = "IEC 60812:2018";
+        attribute :>> edition = "2018";
+        attribute :>> issuer = "IEC";
+        // 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 iec60812Clause5 : StandardClause {
+        attribute :>> id = "STD-IEC-60812-5";
+        attribute :>> name = "IEC60812Clause5";
+        attribute :>> clauseNumber = "5";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60812Clause6 : StandardClause {
+        attribute :>> id = "STD-IEC-60812-6";
+        attribute :>> name = "IEC60812Clause6";
+        attribute :>> clauseNumber = "6";
+        attribute :>> normativeStrength = "shall";
+    }
+    item iec60812Clause7 : StandardClause {
+        attribute :>> id = "STD-IEC-60812-7";
+        attribute :>> name = "IEC60812Clause7";
+        attribute :>> clauseNumber = "7";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection iec60812Has5 : Composes connect parent ::> iec60812 to child ::> iec60812Clause5;
+    connection iec60812Has6 : Composes connect parent ::> iec60812 to child ::> iec60812Clause6;
+    connection iec60812Has7 : Composes connect parent ::> iec60812 to child ::> iec60812Clause7;
+}

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;
+}