@memoarchitect/ontology 0.7.0 → 0.8.22

package/examples/gpca-pump/model/catalog/gpca_standards.sysml

@@ -0,0 +1,161 @@
+// Clause-level conformance for the GPCA pump example.
+//
+// The standards library (src/artifacts/standards/) is MEMO content: it says
+// which clauses exist. This file is PROJECT content: it says which of this
+// project's elements claim them, and where the evidence is written down. That
+// division is the two-mechanism rule in memo_artifacts_standards_traceability
+// — @StandardReference is library provenance, ConformsTo is project
+// traceability — and it is why the clause instances carry no project data and
+// this file declares no clauses.
+//
+// It exists so the DHF standards-traceability, SAD conformance and HRS clause
+// tables render real rows. A `select: relationships` query over ConformsTo is
+// only as good as the edges a project authors, and an example with none cannot
+// tell a working matrix apart from a broken one.
+package memo_examples_gpca_pump_gpca_standards {
+    private import ScalarValues::*;
+
+    private import memo_core_common::*;
+    private import memo_core_enumerations::*;
+    private import memo_core_relationships::*;
+    private import memo_artifacts_core::*;
+    private import memo_artifacts_standards_traceability::*;
+    private import memo_artifacts_standards_iec_62304::*;
+    private import memo_artifacts_standards_iec_60601_1::*;
+    private import memo_artifacts_standards_iec_60601_1_2::*;
+    private import memo_artifacts_standards_iso_14971::*;
+    private import memo_examples_gpca_pump_gpca_requirements::*;
+    private import memo_examples_gpca_pump_gpca_architecture::*;
+    private import memo_examples_gpca_pump_gpca_physical::*;
+    private import memo_examples_gpca_pump_gpca_risk::*;
+
+    // ── The controlled documents clause evidence lands in ────────────────
+    // TracesToDocument targets ControlledArtifact, so the DHF documents are
+    // modelled as the artifacts they are rather than as a second document type.
+
+    part docSrs : MarkdownDocumentSource {
+        attribute :>> id = "DOC-SRS";
+        attribute :>> name = "SoftwareRequirementsSpecification";
+        attribute :>> version = "1.0";
+        attribute :>> artifactKind = ArtifactKind::requirementSpecification;
+        attribute :>> owner = "Software Lead";
+        attribute :>> approvalStatus = "approved";
+        attribute :>> uri = "dhf/documents/srs.md";
+        attribute :>> mediaType = "text/markdown";
+        attribute :>> contentHash = "";
+        attribute :>> generated = true;
+    }
+    part docSad : MarkdownDocumentSource {
+        attribute :>> id = "DOC-SAD";
+        attribute :>> name = "SoftwareArchitectureDescription";
+        attribute :>> version = "1.0";
+        attribute :>> artifactKind = ArtifactKind::architectureDescription;
+        attribute :>> owner = "Systems Architect";
+        attribute :>> approvalStatus = "approved";
+        attribute :>> uri = "dhf/documents/sad.md";
+        attribute :>> mediaType = "text/markdown";
+        attribute :>> contentHash = "";
+        attribute :>> generated = true;
+    }
+    part docHrs : MarkdownDocumentSource {
+        attribute :>> id = "DOC-HRS";
+        attribute :>> name = "HardwareRequirementsSpecification";
+        attribute :>> version = "1.0";
+        attribute :>> artifactKind = ArtifactKind::requirementSpecification;
+        attribute :>> owner = "Hardware Lead";
+        attribute :>> approvalStatus = "approved";
+        attribute :>> uri = "dhf/documents/hrs.md";
+        attribute :>> mediaType = "text/markdown";
+        attribute :>> contentHash = "";
+        attribute :>> generated = true;
+    }
+    part docRmf : MarkdownDocumentSource {
+        attribute :>> id = "DOC-RMF";
+        attribute :>> name = "RiskManagementFile";
+        attribute :>> version = "1.0";
+        attribute :>> artifactKind = ArtifactKind::riskRecord;
+        attribute :>> owner = "Risk Manager";
+        attribute :>> approvalStatus = "approved";
+        attribute :>> uri = "dhf/documents/rmf.md";
+        attribute :>> mediaType = "text/markdown";
+        attribute :>> contentHash = "";
+        attribute :>> generated = true;
+    }
+
+    // ── IEC 62304 — software lifecycle ───────────────────────────────────
+    // §5.2.2 software requirements content: every software requirement.
+    connection : ConformsTo connect conformingElement ::> reqOcclusion to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqDoorOpen to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqMaxHourlyDose to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqEventLogging to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqWatchdogSafeState to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqStuckButton to clause ::> iec62304Clause5_2_2;
+    connection : ConformsTo connect conformingElement ::> reqFlowCrossCheck to clause ::> iec62304Clause5_2_2;
+
+    // §5.2.3 risk control measures carried into software requirements.
+    connection : ConformsTo connect conformingElement ::> reqWatchdogSafeState to clause ::> iec62304Clause5_2_3;
+    connection : ConformsTo connect conformingElement ::> reqFlowCrossCheck to clause ::> iec62304Clause5_2_3;
+
+    // §5.3 software architectural design: the software decomposition.
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware to clause ::> iec62304Clause5_3;
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware.tlm to clause ::> iec62304Clause5_3;
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware.infusionMgr to clause ::> iec62304Clause5_3;
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware.systemMonitor to clause ::> iec62304Clause5_3;
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware.config to clause ::> iec62304Clause5_3;
+
+    // ── IEC 60601-1 — basic safety and essential performance ─────────────
+    // §8 protection against electrical hazards.
+    connection : ConformsTo connect conformingElement ::> reqBatteryBackup to clause ::> iec60601_1Clause8;
+    connection : ConformsTo connect conformingElement ::> powerSupply to clause ::> iec60601_1Clause8;
+    connection : ConformsTo connect conformingElement ::> batteryPack to clause ::> iec60601_1Clause8;
+
+    // §9 protection against mechanical hazards.
+    connection : ConformsTo connect conformingElement ::> reqFreeFlowPrevention to clause ::> iec60601_1Clause9;
+    connection : ConformsTo connect conformingElement ::> antiFreeFlowValve to clause ::> iec60601_1Clause9;
+    connection : ConformsTo connect conformingElement ::> enclosure to clause ::> iec60601_1Clause9;
+
+    // §14 programmable electrical medical systems.
+    connection : ConformsTo connect conformingElement ::> gpcaDevice.gpcaSoftware to clause ::> iec60601_1Clause14;
+
+    // ── IEC 60601-1-2 — electromagnetic compatibility ────────────────────
+    connection : ConformsTo connect conformingElement ::> controllerBoard to clause ::> iec60601_1_2Clause7;
+    connection : ConformsTo connect conformingElement ::> controllerBoard to clause ::> iec60601_1_2Clause8;
+    connection : ConformsTo connect conformingElement ::> reqPost to clause ::> iec60601_1_2Clause8;
+
+    // ── ISO 14971 — risk management ──────────────────────────────────────
+    // §7 risk control: the risk control measures themselves.
+    connection : ConformsTo connect conformingElement ::> lockoutControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> occlusionAlarmControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> airDetectionControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> freeFlowValveControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> doorInterlockControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> watchdogControl to clause ::> iso14971Clause7;
+    connection : ConformsTo connect conformingElement ::> flowCrossCheckControl to clause ::> iso14971Clause7;
+
+    // ── Where the evidence for each claim is written down ────────────────
+    // The section reference rides on the link, not on a duplicate section type.
+    connection : TracesToDocument connect tracedElement ::> iec62304Clause5_2_2 to artifact ::> docSrs {
+        attribute :>> sectionReference = "3";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec62304Clause5_2_3 to artifact ::> docSrs {
+        attribute :>> sectionReference = "3.2";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec62304Clause5_3 to artifact ::> docSad {
+        attribute :>> sectionReference = "4";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec60601_1Clause8 to artifact ::> docHrs {
+        attribute :>> sectionReference = "4";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec60601_1Clause9 to artifact ::> docHrs {
+        attribute :>> sectionReference = "6";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec60601_1Clause14 to artifact ::> docSad {
+        attribute :>> sectionReference = "6.2";
+    }
+    connection : TracesToDocument connect tracedElement ::> iec60601_1_2Clause7 to artifact ::> docHrs {
+        attribute :>> sectionReference = "5";
+    }
+    connection : TracesToDocument connect tracedElement ::> iso14971Clause7 to artifact ::> docRmf {
+        attribute :>> sectionReference = "5";
+    }
+}

package/examples/gpca-pump/model/catalog/gpca_system.sysml

@@ -28,6 +28,11 @@ package memo_examples_gpca_pump_gpca_system {
         attribute :>> safetyRelevant = true;
         attribute :>> securityRelevant = false;
         attribute :>> description = "Bolus button press through lockout/max-dose check to pump actuation and logging.";
+        perform fcsBolusSense;
+        perform fcsBolusValidate;
+        perform fcsBolusCommand;
+        perform fcsBolusActuate;
+        perform fcsBolusLog;
     }
     action fcsBolusSense : FunctionalFlowStep {
         attribute :>> id = "FCS-001"; attribute :>> name = "SenseBolusRequest";
@@ -62,6 +67,10 @@ package memo_examples_gpca_pump_gpca_system {
         attribute :>> safetyRelevant = true;
         attribute :>> securityRelevant = false;
         attribute :>> description = "Sensor condition through alarm evaluation to same-step transition to PAUSED (KVO flow, REQ 43) and annunciation.";
+        perform fcsAlarmSense;
+        perform fcsAlarmEvaluate;
+        perform fcsAlarmStopInfusion;
+        perform fcsAlarmAnnunciate;
     }
     action fcsAlarmSense : FunctionalFlowStep {
         attribute :>> id = "FCS-006"; attribute :>> name = "SenseAlarmCondition";
@@ -91,20 +100,24 @@ package memo_examples_gpca_pump_gpca_system {
         attribute :>> safetyRelevant = true;
         attribute :>> securityRelevant = false;
         attribute :>> description = "Power-on through CPU/memory/sensor self test to IDLE with status display; failed POST blocks therapy.";
+        perform fnSelfTest;
+        perform fnPresentStatus;
     }
 
     // ── System scenarios ────────────────────────────────────────
-    action ssBolusDuringBasal : FunctionalScenario {
+    action ssBolusDuringBasal : MemoScenario {
         attribute :>> id = "SS-001";
         attribute :>> name = "PatientBolusDuringBasal";
+        attribute :>> scenarioKind = ScenarioKind::functional;
         attribute :>> variantKind = ScenarioVariantKind::nominal;
         attribute :>> operationalCondition = OperationalConditionKind::normal;
         attribute :>> preCondition = "BASAL mode active; no REQ 25 ignore condition holds";
         attribute :>> postCondition = "PATIENT_BOLUS mode entered, bolus delivered, return to BASAL";
     }
-    action ssAlarmPause : FunctionalScenario {
+    action ssAlarmPause : MemoScenario {
         attribute :>> id = "SS-002";
         attribute :>> name = "InhibitingNotificationPausesInfusion";
+        attribute :>> scenarioKind = ScenarioKind::functional;
         attribute :>> variantKind = ScenarioVariantKind::exception;
         attribute :>> variationPoint = "an infusion-inhibiting notification interrupts active therapy";
         attribute :>> operationalCondition = OperationalConditionKind::degraded;