@memoarchitect/ontology 0.7.0 → 0.8.22

package/src/artifacts/configuration_management/memo_configuration_management.sysml

@@ -1,5 +1,7 @@
 package memo_artifacts_configuration_management {
+    private import Metaobjects::SemanticMetadata;
     private import ScalarValues::*;
+    private import memo_core_relationships::*;   // MemoRelationship
 
     private import memo_core_common::*;
     private import memo_core_enumerations::*;
@@ -16,4 +18,18 @@ package memo_artifacts_configuration_management {
         attribute baseline : String;
         attribute controlLevel : String;
     }
+
+    // ── Relations owned by this package ─────────────────────────────
+    // Moved out of memo_core_relationships: their ends are typed against
+    // types declared here, and core must not depend on a domain package.
+    connection def Changes :> MemoRelationship {
+        end changeRequest : ChangeRequest :>> source;
+        end changedElement : MemoPart :>> target;
+    }
+    abstract connection changesLinks : Changes[*];
+    metadata def <changes> ChangesMetadata :> SemanticMetadata {
+        :> annotatedElement : SysML::ConnectionDefinition;
+        :> annotatedElement : SysML::ConnectionUsage;
+        :>> baseType = changesLinks meta SysML::Usage;
+    }
 }

package/src/artifacts/core/memo_controlled_artifacts.sysml

@@ -4,7 +4,9 @@ package memo_artifacts_core {
     private import memo_core_common::*;
     private import memo_core_enumerations::*;
 
-    item def ControlledArtifact :> MemoPart {
+    abstract item def MemoArtifactItem :> MemoItem;
+
+    item def ControlledArtifact :> MemoArtifactItem {
         attribute version : String;
         attribute artifactKind : ArtifactKind;
         attribute owner : String;

package/src/artifacts/standards/cfr_21_820.sysml

@@ -0,0 +1,116 @@
+// 21 CFR Part 820 — FDA Quality System Regulation, design controls.
+//
+// Only §820.30 (design controls) and its paragraphs are represented: those are
+// the provisions a design history file traces to. The production, purchasing
+// and records subparts are QMS scope that no model element claims.
+//
+// Terminology: under QMSR (effective February 2026) Part 820 incorporates
+// ISO 13485:2016 by reference, so a project may end up claiming both this pack
+// and the 13485 one for the same document. That is two claims about one
+// artifact, which is exactly what ConformsTo is for — it is not a duplicate
+// registry.
+package memo_artifacts_standards_cfr_21_820 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item cfr21Part820 : RegulatoryStandard {
+        attribute :>> id = "STD-21-CFR-820";
+        attribute :>> name = "CFR21Part820";
+        attribute :>> designation = "21 CFR Part 820";
+        attribute :>> issuer = "FDA";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item cfr820_30 : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30";
+        attribute :>> name = "CFR820_30";
+        attribute :>> clauseNumber = "820.30";
+        attribute :>> title = "design controls";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30a : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-A";
+        attribute :>> name = "CFR820_30a";
+        attribute :>> clauseNumber = "820.30(a)";
+        attribute :>> title = "general design control applicability";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30b : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-B";
+        attribute :>> name = "CFR820_30b";
+        attribute :>> clauseNumber = "820.30(b)";
+        attribute :>> title = "design and development planning";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30c : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-C";
+        attribute :>> name = "CFR820_30c";
+        attribute :>> clauseNumber = "820.30(c)";
+        attribute :>> title = "design input";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30d : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-D";
+        attribute :>> name = "CFR820_30d";
+        attribute :>> clauseNumber = "820.30(d)";
+        attribute :>> title = "design output";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30e : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-E";
+        attribute :>> name = "CFR820_30e";
+        attribute :>> clauseNumber = "820.30(e)";
+        attribute :>> title = "design review";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30f : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-F";
+        attribute :>> name = "CFR820_30f";
+        attribute :>> clauseNumber = "820.30(f)";
+        attribute :>> title = "design verification";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30g : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-G";
+        attribute :>> name = "CFR820_30g";
+        attribute :>> clauseNumber = "820.30(g)";
+        attribute :>> title = "design validation";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30h : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-H";
+        attribute :>> name = "CFR820_30h";
+        attribute :>> clauseNumber = "820.30(h)";
+        attribute :>> title = "design transfer";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30i : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-I";
+        attribute :>> name = "CFR820_30i";
+        attribute :>> clauseNumber = "820.30(i)";
+        attribute :>> title = "design changes";
+        attribute :>> normativeStrength = "shall";
+    }
+    item cfr820_30j : StandardClause {
+        attribute :>> id = "STD-21-CFR-820-30-J";
+        attribute :>> name = "CFR820_30j";
+        attribute :>> clauseNumber = "820.30(j)";
+        attribute :>> title = "design history file";
+        attribute :>> normativeStrength = "shall";
+    }
+
+    connection cfr820Has30 : Composes connect parent ::> cfr21Part820 to child ::> cfr820_30;
+
+    connection cfr820_30HasA : Composes connect parent ::> cfr820_30 to child ::> cfr820_30a;
+    connection cfr820_30HasB : Composes connect parent ::> cfr820_30 to child ::> cfr820_30b;
+    connection cfr820_30HasC : Composes connect parent ::> cfr820_30 to child ::> cfr820_30c;
+    connection cfr820_30HasD : Composes connect parent ::> cfr820_30 to child ::> cfr820_30d;
+    connection cfr820_30HasE : Composes connect parent ::> cfr820_30 to child ::> cfr820_30e;
+    connection cfr820_30HasF : Composes connect parent ::> cfr820_30 to child ::> cfr820_30f;
+    connection cfr820_30HasG : Composes connect parent ::> cfr820_30 to child ::> cfr820_30g;
+    connection cfr820_30HasH : Composes connect parent ::> cfr820_30 to child ::> cfr820_30h;
+    connection cfr820_30HasI : Composes connect parent ::> cfr820_30 to child ::> cfr820_30i;
+    connection cfr820_30HasJ : Composes connect parent ::> cfr820_30 to child ::> cfr820_30j;
+}

package/src/artifacts/standards/fda_cybersecurity_2023.sysml

@@ -0,0 +1,80 @@
+// FDA guidance — "Cybersecurity in Medical Devices: Quality System
+// Considerations and Content of Premarket Submissions" (September 2023).
+//
+// Guidance, not a consensus standard, so every clause here carries
+// normativeStrength = "informative": FDA guidance describes current thinking
+// and is not binding. It is modelled as a RegulatoryStandard all the same,
+// because a submission traces to it exactly the way it traces to IEC 62304 —
+// the traceability question is identical, only the enforceability differs, and
+// that difference is data on the clause rather than a second mechanism.
+//
+// Reference granularity is the guidance's own lettered section structure
+// (IV, V.A, …), not a decimal clause numbering — this document has none. The
+// templates previously cited decimal numbers ("3.2", "5.2") that match no
+// section of the published guidance; those were replaced when this pack landed.
+package memo_artifacts_standards_fda_cybersecurity_2023 {
+    private import ScalarValues::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_standards_traceability::*;
+
+    item fdaCybersecurity2023 : RegulatoryStandard {
+        attribute :>> id = "STD-FDA-CYBER-2023";
+        attribute :>> name = "FDACybersecurity2023";
+        attribute :>> designation = "FDA Cybersecurity Guidance 2023";
+        attribute :>> edition = "2023-09";
+        attribute :>> issuer = "FDA";
+        attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
+    }
+
+    item fdaCyberSection4 : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-IV";
+        attribute :>> name = "FDACyberSectionIV";
+        attribute :>> clauseNumber = "IV";
+        attribute :>> title = "general cybersecurity principles";
+        attribute :>> normativeStrength = "informative";
+    }
+    item fdaCyberSection5 : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-V";
+        attribute :>> name = "FDACyberSectionV";
+        attribute :>> clauseNumber = "V";
+        attribute :>> title = "secure product development framework";
+        attribute :>> normativeStrength = "informative";
+    }
+    item fdaCyberSection5A : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-V-A";
+        attribute :>> name = "FDACyberSectionVA";
+        attribute :>> clauseNumber = "V.A";
+        attribute :>> title = "security risk management";
+        attribute :>> normativeStrength = "informative";
+    }
+    item fdaCyberSection5B : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-V-B";
+        attribute :>> name = "FDACyberSectionVB";
+        attribute :>> clauseNumber = "V.B";
+        attribute :>> title = "security architecture";
+        attribute :>> normativeStrength = "informative";
+    }
+    item fdaCyberSection5C : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-V-C";
+        attribute :>> name = "FDACyberSectionVC";
+        attribute :>> clauseNumber = "V.C";
+        attribute :>> title = "cybersecurity testing";
+        attribute :>> normativeStrength = "informative";
+    }
+    item fdaCyberSection6 : StandardClause {
+        attribute :>> id = "STD-FDA-CYBER-2023-VI";
+        attribute :>> name = "FDACyberSectionVI";
+        attribute :>> clauseNumber = "VI";
+        attribute :>> title = "cybersecurity transparency and vulnerability management";
+        attribute :>> normativeStrength = "informative";
+    }
+
+    connection fdaCyberHas4 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection4;
+    connection fdaCyberHas5 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection5;
+    connection fdaCyberHas6 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection6;
+
+    connection fdaCyberHas5A : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5A;
+    connection fdaCyberHas5B : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5B;
+    connection fdaCyberHas5C : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5C;
+}

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;
+}