@memoarchitect/ontology 0.6.5 → 0.8.22
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/README.md +4 -2
- package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +1 -1
- package/examples/connected-patient-monitor/model/catalog/project.sysml +24 -0
- package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/connected-patient-monitor/model/{viewpoints → catalog/viewpoints/unassigned/views}/connected_patient_monitor_overview.sysml +1 -1
- package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +7 -5
- package/examples/embedded-infusion-pump/model/catalog/project.sysml +24 -0
- package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/embedded-infusion-pump/model/{viewpoints → catalog/viewpoints/unassigned/views}/embedded_infusion_pump_overview.sysml +1 -1
- package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +5 -5
- package/examples/functional-logical-physical/model/catalog/project.sysml +24 -0
- package/examples/functional-logical-physical/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/functional-logical-physical/model/{viewpoints → catalog/viewpoints/unassigned/views}/functional_logical_physical_overview.sysml +1 -1
- package/examples/gpca-pump/methodology/gpca_methodology.sysml +7 -8
- package/examples/gpca-pump/methodology/gpca_profiles.sysml +89 -11
- package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +19 -9
- package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +342 -100
- package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +27 -13
- package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +329 -272
- package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +57 -16
- package/examples/gpca-pump/model/catalog/gpca_context.sysml +12 -8
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +14 -10
- package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +1 -15
- package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +181 -264
- package/examples/gpca-pump/model/catalog/gpca_operational.sysml +95 -60
- package/examples/gpca-pump/model/catalog/gpca_physical.sysml +6 -11
- package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +102 -101
- package/examples/gpca-pump/model/catalog/gpca_risk.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_standards.sysml +161 -0
- package/examples/gpca-pump/model/catalog/gpca_system.sysml +47 -30
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +301 -354
- package/examples/gpca-pump/model/catalog/gpca_verification.sysml +116 -36
- package/examples/gpca-pump/model/catalog/project.sysml +26 -0
- package/examples/gpca-pump/model/catalog/viewpoints/context/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/context/views}/context_system_context_view.sysml +4 -4
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/cybersecurity_cybersecurity_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_cyber_assessment_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_threat_model_view.sysml +5 -5
- package/examples/gpca-pump/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_allocation_view.sysml +2 -2
- package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_browser_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/behavior_action_flow_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/document_architecture_description_view.sysml +8 -8
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_device_interconnect_view.sysml +5 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_logical_architecture_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_mode_state_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_system_decomposition_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/operational/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_scenario_sequence_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_use_case_view.sysml +4 -4
- package/examples/gpca-pump/model/catalog/viewpoints/physical/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/physical/views}/physical_physical_bom_view.sysml +2 -2
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/document_dhf_index_view.sysml +8 -8
- package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/requirements_requirements_trace_view.sysml +2 -2
- package/examples/gpca-pump/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_hazard_analysis_view.sysml +8 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_rmf_view.sysml +7 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_fmea_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_risk_chain_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/software/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/document_sdd_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/software_software_architecture_view.sysml +5 -5
- package/examples/gpca-pump/model/catalog/viewpoints/usability/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/usability/views}/document_usability_view.sysml +8 -6
- package/examples/gpca-pump/model/catalog/viewpoints/verification/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/document_vv_view.sysml +7 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/verification_verification_coverage_view.sysml +3 -3
- package/examples/ivd-laboratory-system/model/catalog/project.sysml +24 -0
- package/examples/ivd-laboratory-system/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/ivd-laboratory-system/model/{viewpoints → catalog/viewpoints/unassigned/views}/ivd_laboratory_system_overview.sysml +1 -1
- package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +4 -2
- package/examples/manual-surgical-instrument/model/catalog/project.sysml +24 -0
- package/examples/manual-surgical-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/manual-surgical-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/manual_surgical_instrument_overview.sysml +1 -1
- package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -2
- package/examples/multidimensional-layers/model/catalog/project.sysml +24 -0
- package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/multidimensional-layers/model/{viewpoints → catalog/viewpoints/unassigned/views}/multidimensional_layers_overview.sysml +1 -1
- package/examples/nested-architecture-dsm/README.md +49 -0
- package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +179 -0
- package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +165 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +53 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +89 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +113 -0
- package/examples/nested-architecture-dsm/model/catalog/project.sysml +28 -0
- package/examples/nested-architecture-dsm/model/catalog/traces.sysml +48 -0
- package/examples/reusable-instrument/model/catalog/project.sysml +24 -0
- package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +11 -8
- package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/reusable-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/reusable_instrument_overview.sysml +1 -1
- package/examples/ros-mobile-robot/README.md +40 -0
- package/examples/ros-mobile-robot/model/catalog/project.sysml +33 -0
- package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +296 -0
- package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +7 -0
- package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/views/ros_mobile_robot_overview.sysml +13 -0
- package/examples/software-only-medical-device/model/catalog/project.sysml +28 -0
- package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +11 -5
- package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/software-only-medical-device/model/{viewpoints → catalog/viewpoints/unassigned/views}/software_only_medical_device_overview.sysml +1 -1
- package/examples/surgical-closure-workflow/model/catalog/project.sysml +24 -0
- package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +57 -57
- package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/surgical-closure-workflow/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_closure_workflow_overview.sysml +1 -1
- package/examples/surgical-robot/model/catalog/project.sysml +24 -0
- package/examples/surgical-robot/model/catalog/surgical_robot.sysml +6 -4
- package/examples/surgical-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/surgical-robot/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_robot_overview.sysml +1 -1
- package/examples/sysml-diagram-samples/README.md +7 -0
- package/examples/sysml-diagram-samples/dhf/documents/DOC-HAR-001.md +11 -0
- package/examples/sysml-diagram-samples/memo.package.yaml +11 -5
- package/examples/sysml-diagram-samples/model/catalog/project.sysml +33 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/action_flow_view.sysml +23 -20
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/context_view.sysml +11 -11
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.viewlayout +47 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +143 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +87 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.viewlayout +94 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +109 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.viewlayout +13 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/requirements_view.sysml +6 -7
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +33 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +80 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +48 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/use_case_view.sysml +15 -9
- package/examples/sysml-diagram-samples/model/sysml_v2_activity_example.sysml +93 -0
- package/examples/temperature-alarm/model/catalog/project.sysml +24 -0
- package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +29 -21
- package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/temperature-alarm/model/{viewpoints → catalog/viewpoints/unassigned/views}/temperature_alarm_overview.sysml +1 -1
- package/examples/ui-screen-regions/README.md +117 -0
- package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +84 -0
- package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +212 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +61 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/drugSelectorRegion/drug-selector-expanded-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/mainScreenLayout/main-screen-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/settingsScreenLayout/settings-screen-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +51 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +27 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +27 -0
- package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +59 -0
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +25 -0
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +178 -0
- package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +93 -0
- package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +75 -0
- package/examples/ui-screen-regions/model/catalog/project.sysml +45 -0
- package/examples/ui-screen-regions/model/catalog/relationships.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/traces.sysml +179 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +57 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +52 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +54 -0
- package/extensions/LICENSES/MIT.txt +19 -0
- package/extensions/README.md +94 -0
- package/extensions/aadl/memo.package.yaml +18 -0
- package/extensions/aadl/src/aadl_extension.sysml +6 -0
- package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +147 -0
- package/extensions/aadl/src/methodology/aadl_methodology.sysml +17 -0
- package/extensions/aadl/src/runtime/memo_aadl_runtime.sysml +56 -0
- package/extensions/clinical/memo.package.yaml +18 -0
- package/extensions/clinical/src/methodology/clinical_methodology.sysml +22 -0
- package/extensions/cloud/memo.package.yaml +18 -0
- package/extensions/cloud/src/cloud_extension.sysml +44 -0
- package/extensions/cloud/src/methodology/cloud_methodology.sysml +17 -0
- package/extensions/container/memo.package.yaml +18 -0
- package/extensions/container/src/container_extension.sysml +37 -0
- package/extensions/container/src/methodology/container_methodology.sysml +17 -0
- package/extensions/messaging/memo.package.yaml +18 -0
- package/extensions/messaging/src/messaging_extension.sysml +64 -0
- package/extensions/messaging/src/methodology/messaging_methodology.sysml +17 -0
- package/extensions/ros/memo.package.yaml +18 -0
- package/extensions/ros/src/methodology/ros_methodology.sysml +25 -0
- package/extensions/ros/src/ros_extension.sysml +200 -0
- package/extensions/template/memo.package.yaml +17 -0
- package/extensions/template/src/extension.sysml +37 -0
- package/memo.manifest.yaml +15 -2
- package/methodologies/default/memo.package.yaml +19 -9
- package/methodologies/gpca/memo.package.yaml +18 -9
- package/ontology/memo.package.yaml +23 -8
- package/package.json +6 -6
- package/profile/memo.package.yaml +18 -9
- package/src/architecture/decisions/memo_decisions.sysml +28 -0
- package/src/architecture/functional/behavior/memo_behavior.sysml +50 -22
- package/src/architecture/functional/constraints/memo_constraints.sysml +3 -2
- package/src/architecture/functional/functions/memo_functions.sysml +93 -43
- package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +46 -24
- package/src/architecture/implementation/software/structure/memo_software_structure.sysml +52 -12
- package/src/architecture/implementation/ui/memo_ui.sysml +276 -53
- package/src/architecture/logical/interfaces/memo_interfaces.sysml +64 -13
- package/src/architecture/logical/structure/memo_logical_structure.sysml +92 -35
- package/src/architecture/operational/activities/memo_activities.sysml +10 -4
- package/src/architecture/operational/context/actors/memo_actors.sysml +5 -8
- package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +13 -30
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +42 -16
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +57 -23
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +35 -26
- package/src/architecture/operational/workflows/memo_workflows.sysml +28 -15
- package/src/architecture/realization/deployment/memo_deployment.sysml +111 -16
- package/src/architecture/realization/physical/memo_physical_architecture.sysml +27 -2
- package/src/artifacts/configuration_management/memo_configuration_management.sysml +35 -0
- package/src/artifacts/core/memo_controlled_artifacts.sysml +35 -0
- package/src/artifacts/documents/risk_management/memo_risk_management.sysml +12 -0
- package/src/artifacts/standards/cfr_21_820.sysml +116 -0
- package/src/artifacts/standards/fda_cybersecurity_2023.sysml +80 -0
- package/src/artifacts/standards/iec_60601_1.sysml +149 -0
- package/src/artifacts/standards/iec_60601_1_2.sysml +56 -0
- package/src/artifacts/standards/iec_60812.sysml +51 -0
- package/src/artifacts/standards/iec_62304.sysml +210 -0
- package/src/artifacts/standards/iec_62366_1.sysml +113 -0
- package/src/artifacts/standards/iec_81001_5_1.sysml +84 -0
- package/src/artifacts/standards/iso_13485.sysml +113 -0
- package/src/artifacts/standards/iso_14971.sysml +94 -0
- package/src/artifacts/standards/iso_iec_ieee_42010.sysml +42 -0
- package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml +132 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-input.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-output.md +5 -5
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-review.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-validation.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-verification.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/dhf-index.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/transfer-plan.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/user-needs.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-plan.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-report.md +4 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/incident-response.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/postmarket-surveillance.md +3 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/security-arch.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/threat-model.md +4 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/vuln-assessment.md +4 -3
- package/src/artifacts/templates/dhf/iec-60601/hrs.md +170 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/detailed-design.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/integration-test.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sad.md +6 -5
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sbom.md +3 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sdp.md +5 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/soup.md +4 -2
- package/src/artifacts/templates/dhf/iec-62304/srs.md +172 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sw-traceability.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/system-test.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/summative-eval.md +1 -1
- package/src/artifacts/templates/dhf/iec-62366/task-analysis.md +93 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ue-plan.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/urra.md +3 -3
- package/src/artifacts/templates/dhf/iso-14971/fmea.md +116 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/har.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmp.md +2 -2
- package/src/artifacts/templates/dhf/system/sad.md +173 -0
- package/src/artifacts/templates/dhf/system/standards-checklist.md +87 -0
- package/src/artifacts/templates/dhf/system/standards-traceability.md +125 -0
- package/src/artifacts/templates/dhf/system/syrs.md +128 -0
- package/src/assurance/cybersecurity/memo_cybersecurity.sysml +39 -20
- package/src/assurance/human_factors/memo_human_factors.sysml +29 -22
- package/src/assurance/requirements/memo_requirements.sysml +5 -2
- package/src/assurance/requirements/needs/memo_needs.sysml +1 -1
- package/src/assurance/safety_risk/analysis/memo_fmea.sysml +118 -13
- package/src/assurance/safety_risk/memo_risk.sysml +78 -7
- package/src/assurance/safety_risk/postmarket_surveillance/memo_postmarket_surveillance.sysml +27 -0
- package/src/assurance/verification_validation/clinical_evaluation/memo_clinical_evaluation.sysml +11 -0
- package/src/assurance/verification_validation/memo_assurance.sysml +17 -21
- package/src/core/annotations/memo_annotations.sysml +96 -0
- package/src/core/common/memo_common.sysml +140 -18
- package/src/core/consistency_rules/consistency_rules.sysml +7 -0
- package/src/core/dimensions/dimensions.sysml +17 -1
- package/src/core/enumerations/memo_enumerations.sysml +101 -20
- package/src/core/methodology_scope/methodology_scope.sysml +7 -15
- package/src/core/relationships/memo_relationships.sysml +199 -194
- package/src/memo_namespaces.sysml +127 -67
- package/src/methodology/core/memo_core.sysml +69 -2
- package/src/methodology/profiles/memo_profiles.sysml +31 -41
- package/src/methodology/workflow/memo_workflow.sysml +7 -2
- package/src/rules/closure/closure_rules.sysml +104 -31
- package/src/rules/coverage/coverage_rules.sysml +4 -256
- package/src/rules/crosslayer/cross_layer_rules.sysml +6 -15
- package/src/rules/lifecycle/lifecycle_rules.sysml +4 -39
- package/src/rules/ontology/ontology_invariants.sysml +243 -74
- package/src/rules/quantitative/quantitative_rules.sysml +8 -8
- package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +10 -3
- package/src/viewpoints/clinical/clinical_viewpoint.sysml +4 -2
- package/src/viewpoints/clinical/{clinical_evidence_view → views/clinical_evidence_view}/clinical_evidence_view.sysml +2 -2
- package/src/viewpoints/context/context_viewpoint.sysml +4 -2
- package/src/viewpoints/context/{system_context_view → views/system_context_view}/system_context_view.sysml +2 -2
- package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +4 -2
- package/src/viewpoints/cybersecurity/{cybersecurity_assessment_view → views/cybersecurity_assessment_view}/cybersecurity_assessment_view.sysml +2 -2
- package/src/viewpoints/cybersecurity/{threat_model_view → views/threat_model_view}/threat_model_view.sysml +2 -2
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +5 -0
- package/src/viewpoints/functional/functional_viewpoint.sysml +4 -2
- package/src/viewpoints/functional/{function_allocation_view → views/function_allocation_view}/function_allocation_view.sysml +3 -3
- package/src/viewpoints/functional/{system_functional_tree_view → views/system_functional_tree_view}/system_functional_tree_view.sysml +3 -3
- package/src/viewpoints/logical/logical_viewpoint.sysml +3 -1
- package/src/viewpoints/logical/{logical_architecture_view → views/logical_architecture_view}/logical_architecture_view.sysml +2 -2
- package/src/viewpoints/operational/operational_viewpoint.sysml +4 -2
- package/src/viewpoints/operational/{use_case_view → views/use_case_view}/use_case_view.sysml +3 -3
- package/src/viewpoints/physical/physical_viewpoint.sysml +3 -1
- package/src/viewpoints/physical/{network_topology_view → views/network_topology_view}/network_topology_view.sysml +2 -2
- package/src/viewpoints/physical/{physical_bom_view → views/physical_bom_view}/physical_bom_view.sysml +2 -2
- package/src/viewpoints/rendering/memo_rendering.sysml +354 -0
- package/src/viewpoints/requirements/requirements_viewpoint.sysml +3 -1
- package/src/viewpoints/requirements/{requirements_traceability_view → views/requirements_traceability_view}/requirements_traceability_view.sysml +2 -2
- package/src/viewpoints/risk/risk_viewpoint.sysml +3 -1
- package/src/viewpoints/risk/{risk_chain_view → views/risk_chain_view}/risk_chain_view.sysml +2 -2
- package/src/viewpoints/software/software_viewpoint.sysml +3 -1
- package/src/viewpoints/software/{software_architecture_view → views/software_architecture_view}/software_architecture_view.sysml +2 -2
- package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +28 -0
- package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +23 -0
- package/src/viewpoints/usability/usability_viewpoint.sysml +3 -1
- package/src/viewpoints/usability/{usability_engineering_view → views/usability_engineering_view}/usability_engineering_view.sysml +2 -2
- package/src/viewpoints/verification/verification_viewpoint.sysml +4 -2
- package/src/viewpoints/verification/{verification_coverage_view → views/verification_coverage_view}/verification_coverage_view.sysml +3 -3
- package/templates/connected-device/memo.package.yaml +11 -5
- package/templates/connected-device/model/catalog/project.sysml +28 -0
- package/templates/connected-device/syside.toml +1 -1
- package/templates/default/memo.package.yaml +11 -5
- package/templates/default/model/catalog/project.sysml +28 -0
- package/templates/default/syside.toml +1 -1
- package/templates/infusion-pump/memo.package.yaml +11 -5
- package/templates/infusion-pump/model/catalog/project.sysml +28 -0
- package/templates/infusion-pump/syside.toml +1 -1
- package/templates/monitoring-device/memo.package.yaml +11 -5
- package/templates/monitoring-device/model/catalog/project.sysml +28 -0
- package/templates/monitoring-device/syside.toml +1 -1
- package/templates/samd/memo.package.yaml +11 -5
- package/templates/samd/model/catalog/project.sysml +28 -0
- package/templates/samd/syside.toml +1 -1
- package/examples/connected-patient-monitor/model/connected_patient_monitor.sysml +0 -3
- package/examples/embedded-infusion-pump/model/embedded_infusion_pump.sysml +0 -3
- package/examples/extensions/README.md +0 -16
- package/examples/extensions/clinical/memo.package.yaml +0 -9
- package/examples/extensions/clinical/src/methodology/clinical_methodology.sysml +0 -14
- package/examples/extensions/template/memo.package.yaml +0 -9
- package/examples/extensions/template/src/extension.sysml +0 -15
- package/examples/functional-logical-physical/model/functional_logical_physical.sysml +0 -3
- package/examples/gpca-pump/memo.config.yaml +0 -9
- package/examples/gpca-pump/methodology/gpca_scope.sysml +0 -25
- package/examples/ivd-laboratory-system/model/ivd_laboratory_system.sysml +0 -3
- package/examples/manual-surgical-instrument/model/manual_surgical_instrument.sysml +0 -3
- package/examples/multidimensional-layers/model/multidimensional_layers.sysml +0 -4
- package/examples/reusable-instrument/model/reusable_instrument.sysml +0 -4
- package/examples/software-only-medical-device/model/software_only_medical_device.sysml +0 -4
- package/examples/surgical-closure-workflow/model/surgical_closure_workflow.sysml +0 -4
- package/examples/surgical-robot/model/surgical_robot.sysml +0 -4
- package/examples/sysml-diagram-samples/model/samples/functional_flow_view.sysml +0 -164
- package/examples/sysml-diagram-samples/model/samples/interconnection_view.sysml +0 -94
- package/examples/sysml-diagram-samples/model/samples/operational_behaviour_view.sysml +0 -135
- package/examples/sysml-diagram-samples/model/samples/state_transition_view.sysml +0 -109
- package/examples/sysml-diagram-samples/model/samples/tree_view.sysml +0 -56
- package/examples/temperature-alarm/model/temperature_alarm.sysml +0 -4
- package/ontology/memo.rendering.yaml +0 -84
- package/src/compliance/artifacts/memo_artifacts.sysml +0 -12
- package/src/compliance/change/memo_change.sysml +0 -17
- package/src/compliance/dhf-templates/iec-62304/srs.md +0 -138
- package/src/compliance/dhf-templates/iec-62366/task-analysis.md +0 -57
- package/src/compliance/dhf-templates/iso-14971/fmea.md +0 -93
- package/src/compliance/document_views/memo_document_views.sysml +0 -7
- package/src/compliance/iso14971/risk_management_file.sysml +0 -16
- package/src/compliance/postmarket/memo_postmarket.sysml +0 -16
- /package/{examples/extensions → extensions}/clinical/src/clinical_extension.sysml +0 -0
- /package/{examples/extensions → extensions}/clinical/src/procedures/memo_clinical_procedures.sysml +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/change-record.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/change-control.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/formative-eval.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ui-spec.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/use-spec.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/fta.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-benefit.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-matrix.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmr.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/approval-block.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/document-control-header.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/references-section.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/revision-history-table.md +0 -0
- /package/templates/connected-device/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/connected-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/connected-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/default/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/default/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/default/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/infusion-pump/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/infusion-pump/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/infusion-pump/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/monitoring-device/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/monitoring-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/monitoring-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/samd/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/samd/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/samd/{src → model/catalog}/assurance/requirements.sysml +0 -0
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package
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package memo_examples_gpca_pump_gpca_verification {
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private import memo_examples_gpca_pump_gpca_requirements::*;
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private import memo_examples_gpca_pump_gpca_formal_behavior::*;
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private import memo_examples_gpca_pump_gpca_risk::*;
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private import memo_examples_gpca_pump_gpca_behavior_modes::*;
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private import memo_examples_sysml_diagram_samples_viewpoints_unassigned_views_requirements_view::*;
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private import memo_core_dimensions::*; // ElementStatusKind
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// ── Verification cases ──────────────────────────────────────
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verification vcModeRange : VerificationCase {
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attribute :>> name = "VerifyModeRange";
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attribute :>> methodKind = VerificationMethodKind::formalProof;
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attribute :>> acceptanceCriteria = "Current_System_mode only takes valid exclusive values";
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attribute :>> status =
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqCs01; }
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subject verified : Base::Anything[*] = (guaranteeExclusiveMode, gpcaDevice.gpcaSoftware.tlm, gpcaDevice.gpcaSoftware.outputBus);
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verification vcLockout : VerificationCase {
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attribute :>> id = "VER-002";
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attribute :>> name = "VerifyBolusLockout";
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attribute :>> acceptanceCriteria = "No patient bolus initiated when lockout or max bolus constraints active";
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attribute :>> status =
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objective { verify reqCs25; }
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subject verified : Base::Anything[*] = (lockoutControl, guaranteeLockoutPreventsBolus, tcBolusResponse, gpcaDevice.gpcaSoftware.infusionMgr);
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verification vcSameStepAlarm : VerificationCase {
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attribute :>> id = "VER-003";
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attribute :>> status =
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqCs19; }
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subject verified : Base::Anything[*] = (propAlarmStopsSameStep, guaranteeAlarmStopsSameStep, tcAlarmLatency, gpcaDevice.gpcaSoftware.alarm);
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verification vcTemporalModeSafety : VerificationCase {
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attribute :>> id = "VER-004";
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attribute :>> name = "VerifyTemporalModeSafety";
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attribute :>> methodKind = VerificationMethodKind::modelChecking;
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attribute :>> acceptanceCriteria = "No invalid transitions and pause on critical alarms";
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attribute :>> status =
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqCs75; verify reqDoorOpen; }
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subject verified : Base::Anything[*] = (propLockoutTimerMonotonic, temporalNoInvalidTransition);
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}
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verification vcAirInLine : VerificationCase {
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attribute :>> id = "VER-005";
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attribute :>> name = "VerifyAirInLineStop";
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attribute :>> methodKind = VerificationMethodKind::test;
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attribute :>> acceptanceCriteria = "Injected air above threshold pauses infusion and annunciates per the REQ 59 High-priority actions (REQ-CS-21)";
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attribute :>> status =
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqCs21; }
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subject verified : Base::Anything[*] = (airDetectionControl);
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}
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verification vcOcclusion : VerificationCase {
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attribute :>> id = "VER-006";
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attribute :>> name = "VerifyOcclusionDetection";
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attribute :>> methodKind = VerificationMethodKind::test;
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attribute :>> acceptanceCriteria = "Clamped line above pressure threshold pauses infusion and annunciates (REQ-X-04)";
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attribute :>> status =
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqOcclusion; }
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subject verified : Base::Anything[*] = (occlusionAlarmControl);
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verification vcEmptyReservoir : VerificationCase {
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attribute :>> id = "VER-007";
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attribute :>> acceptanceCriteria = "Reservoir-empty assertion transitions to PAUSED (KVO flow) and annunciates per the REQ 59 High-priority actions (REQ-CS-23)";
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subject verified : Base::Anything[*] = (reservoirMonitorControl, gpcaDevice.gpcaSoftware.systemStatus);
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verification vcPost : VerificationCase {
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attribute :>> acceptanceCriteria = "Each injected POST fault (CPU, RAM, ROM, watchdog, sensors) blocks therapy and alarms (REQ-X-02)";
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subject verified : Base::Anything[*] = (gpcaDevice.gpcaSoftware.systemMonitor);
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verification vcPowerLoss : VerificationCase {
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attribute :>> id = "VER-009";
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attribute :>> name = "VerifyPowerLossRetentionAndResume";
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attribute :>> methodKind = VerificationMethodKind::test;
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attribute :>> acceptanceCriteria = "Prescription and log intact after power cycle; therapy resumes only after confirmation (REQ-X-03)";
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqPowerLossRetention; verify reqBatteryBackup; }
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}
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verification vcWatchdog : VerificationCase {
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attribute :>> id = "VER-010";
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attribute :>> name = "VerifyWatchdogSafeState";
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attribute :>> methodKind = VerificationMethodKind::test;
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attribute :>> acceptanceCriteria = "Induced CPU hang forces zero flow and continuous alarm within 60 ms (REQ-X-08, TC-003)";
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqWatchdogSafeState; }
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subject verified : Base::Anything[*] = (watchdogControl, tcWatchdogTimeout);
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}
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verification vcHourlyMax : VerificationCase {
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attribute :>> id = "VER-011";
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attribute :>> name = "VerifyHourlyDoseCeiling";
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attribute :>> methodKind = VerificationMethodKind::simulation;
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attribute :>> acceptanceCriteria = "Randomized bolus/basal schedules never exceed hourly maximum in sliding window (REQ-X-06)";
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attribute :>> status = ElementStatusKind::approved;
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objective { verify reqMaxHourlyDose; }
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}
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objective { verify reqPumpAccuracy; }
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verification vcAlarmLoudness : VerificationCase {
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objective { verify reqCs72; verify reqAlarmLoudness; }
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verification vcFreeFlow : VerificationCase {
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objective { verify reqFreeFlowPrevention; }
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subject verified : Base::Anything[*] = (freeFlowValveControl);
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verification vcStuckButton : VerificationCase {
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objective { verify reqStuckButton; }
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objective { verify reqFlowCrossCheck; }
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subject verified : Base::Anything[*] = (flowCrossCheckControl);
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objective { verify reqDrugLibraryLimits; }
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subject verified : Base::Anything[*] = (drugLibraryControl, gpcaDevice.gpcaSoftware.config);
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attribute :>> acceptanceCriteria = "Therapy cannot start without distinct confirmation; displayed values equal stored values (REQ-CS-09)";
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objective { verify reqCs09; }
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verification vcEventLog : VerificationCase {
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attribute :>> acceptanceCriteria = "Operational/error log entries per REQ-CS-78..81; tampering detectable (REQ-X-07)";
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objective { verify reqCs78; verify reqEventLogging; }
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subject verified : Base::Anything[*] = (gpcaDevice.gpcaSoftware.logging);
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verification vcReverseDeliveryPause : VerificationCase {
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attribute :>> acceptanceCriteria = "Continuous or cumulative reverse delivery beyond the REQ-CS-22 duration limits transitions to PAUSED and raises the Reverse Delivery notification (NOTIF-04)";
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subject verified : Base::Anything[*] = (reverseDeliveryPauseControl);
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verification vcAntiRefluxMechanism : VerificationCase {
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attribute :>> acceptanceCriteria = "During normal use and single fault condition, continuous reverse delivery is not possible (IEC 601-2-24 basis per GPCA safety requirements)";
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subject verified : Base::Anything[*] = (antiRefluxDesignControl);
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}
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verification vcVtbiCeiling : VerificationCase {
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attribute :>> methodKind = VerificationMethodKind::modelChecking;
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attribute :>> acceptanceCriteria = "Actual volume infused above the drug-database maximum VTBI transitions to PAUSED with flow at most KVO (REQ-CS-20, AGREE GP-008) and raises NOTIF-06";
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subject verified : Base::Anything[*] = (vtbiLimitPauseControl);
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}
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verification vcInfusionComplete : VerificationCase {
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attribute :>> name = "VerifyInfusionCompleteStop";
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attribute :>> acceptanceCriteria = "Reaching prescribed total duration or maximum VTBI transitions ACTIVE to IDLE with Infusion Complete actions (REQ-CS-28)";
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subject verified : Base::Anything[*] = (infusionCompleteControl);
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}
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verification vcDoorInterlock : VerificationCase {
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attribute :>> id = "VER-024";
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attribute :>> name = "VerifyDoorOpenDeliveryInhibit";
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attribute :>> acceptanceCriteria = "Door open during THERAPY limits flow to at most KVO and raises a notification (AGREE GP-011; REQ-X-05)";
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attribute :>> status = ElementStatusKind::approved;
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subject verified : Base::Anything[*] = (doorInterlockControl);
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}
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// ── Validation cases (design validation / IEC 62366) ────────
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}
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// ── Test artifacts and evidence ─────────────────────────────
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part testReportLockout :
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part testReportLockout : MemoEvidence {
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attribute :>> evidenceKind = EvidenceKind::testArtifact;
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attribute :>> id = "TEST-001";
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attribute :>> name = "BolusLockoutTestReport";
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attribute :>> version = "0.1";
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attribute :>> artifactKind = ArtifactKind::testReport;
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attribute :>> resultSummary = "planned";
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}
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part testProtocolSafetySuite :
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part testProtocolSafetySuite : MemoEvidence {
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attribute :>> evidenceKind = EvidenceKind::testArtifact;
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attribute :>> id = "TEST-002";
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attribute :>> name = "SafetyAlarmTestProtocol";
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attribute :>> version = "0.1";
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@@ -210,7 +281,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
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attribute :>> artifactKind = ArtifactKind::testProtocol;
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attribute :>> resultSummary = "covers VER-005..VER-010, VER-015, VER-016, VER-020, VER-022..VER-024";
|
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|
}
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|
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part evidenceLockout :
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part evidenceLockout : MemoEvidence {
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attribute :>> evidenceKind = EvidenceKind::evidence;
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|
attribute :>> id = "EVD-001";
|
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attribute :>> name = "BolusLockoutEvidence";
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attribute :>> version = "0.1";
|
|
@@ -218,7 +290,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
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|
attribute :>> evidenceType = "verification evidence";
|
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|
attribute :>> integrityStatus = "draft";
|
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|
}
|
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|
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part evidenceModeRange :
|
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|
+
part evidenceModeRange : MemoEvidence {
|
|
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|
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attribute :>> evidenceKind = EvidenceKind::evidence;
|
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|
attribute :>> id = "EVD-002";
|
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|
attribute :>> name = "ModeRangeEvidence";
|
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|
attribute :>> version = "0.1";
|
|
@@ -226,7 +299,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
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|
attribute :>> evidenceType = "formal proof evidence";
|
|
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|
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|
|
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|
}
|
|
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|
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part evidenceSameStepAlarm :
|
|
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|
+
part evidenceSameStepAlarm : MemoEvidence {
|
|
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|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
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|
attribute :>> id = "EVD-003";
|
|
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|
attribute :>> name = "SameStepAlarmEvidence";
|
|
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|
attribute :>> version = "0.1";
|
|
@@ -234,7 +308,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
|
|
234
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|
attribute :>> evidenceType = "model checking evidence";
|
|
235
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|
attribute :>> integrityStatus = "draft";
|
|
236
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|
}
|
|
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|
-
part evidenceTemporalModeSafety :
|
|
311
|
+
part evidenceTemporalModeSafety : MemoEvidence {
|
|
312
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
238
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|
attribute :>> id = "EVD-004";
|
|
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|
attribute :>> name = "TemporalModeSafetyEvidence";
|
|
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|
attribute :>> version = "0.1";
|
|
@@ -242,7 +317,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
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|
242
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|
attribute :>> evidenceType = "model checking evidence";
|
|
243
318
|
attribute :>> integrityStatus = "draft";
|
|
244
319
|
}
|
|
245
|
-
part evidenceSafetyAlarmSuite :
|
|
320
|
+
part evidenceSafetyAlarmSuite : MemoEvidence {
|
|
321
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
246
322
|
attribute :>> id = "EVD-005";
|
|
247
323
|
attribute :>> name = "SafetyAlarmSuiteEvidence";
|
|
248
324
|
attribute :>> version = "0.1";
|
|
@@ -250,7 +326,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
|
|
250
326
|
attribute :>> evidenceType = "bench test evidence for alarm-driven safe states";
|
|
251
327
|
attribute :>> integrityStatus = "draft";
|
|
252
328
|
}
|
|
253
|
-
part evidenceUsability :
|
|
329
|
+
part evidenceUsability : MemoEvidence {
|
|
330
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
254
331
|
attribute :>> id = "EVD-006";
|
|
255
332
|
attribute :>> name = "SummativeUsabilityEvidence";
|
|
256
333
|
attribute :>> version = "0.1";
|
|
@@ -258,7 +335,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
|
|
258
335
|
attribute :>> evidenceType = "summative usability report per IEC 62366-1";
|
|
259
336
|
attribute :>> integrityStatus = "draft";
|
|
260
337
|
}
|
|
261
|
-
part evidenceHardwareBench :
|
|
338
|
+
part evidenceHardwareBench : MemoEvidence {
|
|
339
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
262
340
|
attribute :>> id = "EVD-008";
|
|
263
341
|
attribute :>> name = "HardwareBenchEvidence";
|
|
264
342
|
attribute :>> version = "0.1";
|
|
@@ -266,7 +344,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
|
|
266
344
|
attribute :>> evidenceType = "bench evidence for alarm loudness and anti-free-flow valve";
|
|
267
345
|
attribute :>> integrityStatus = "draft";
|
|
268
346
|
}
|
|
269
|
-
part evidenceDoseProgramming :
|
|
347
|
+
part evidenceDoseProgramming : MemoEvidence {
|
|
348
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
270
349
|
attribute :>> id = "EVD-009";
|
|
271
350
|
attribute :>> name = "DoseProgrammingEvidence";
|
|
272
351
|
attribute :>> version = "0.1";
|
|
@@ -274,7 +353,8 @@ package memo_examples_gpca_pump_model_catalog_gpca_verification {
|
|
|
274
353
|
attribute :>> evidenceType = "test evidence for prescription limits, confirmation, dose ceiling, and event log";
|
|
275
354
|
attribute :>> integrityStatus = "draft";
|
|
276
355
|
}
|
|
277
|
-
part evidenceDeliveryAccuracy :
|
|
356
|
+
part evidenceDeliveryAccuracy : MemoEvidence {
|
|
357
|
+
attribute :>> evidenceKind = EvidenceKind::evidence;
|
|
278
358
|
attribute :>> id = "EVD-007";
|
|
279
359
|
attribute :>> name = "DeliveryAccuracyEvidence";
|
|
280
360
|
attribute :>> version = "0.1";
|
|
@@ -0,0 +1,26 @@
|
|
|
1
|
+
// GPCA project identity and method binding.
|
|
2
|
+
//
|
|
3
|
+
// This file is the project's native entrypoint. It imports the methodology it
|
|
4
|
+
// selects and states the selection as a typed SysML reference — no YAML field
|
|
5
|
+
// participates in the choice.
|
|
6
|
+
package memo_examples_gpca_pump_project {
|
|
7
|
+
private import ScalarValues::*;
|
|
8
|
+
|
|
9
|
+
private import memo_methodology_core::*;
|
|
10
|
+
private import memo_core_enumerations::*;
|
|
11
|
+
private import memo_examples_gpca_pump_methodology_gpca_profiles::*;
|
|
12
|
+
|
|
13
|
+
part gpcaProjectBinding : ProjectMethodBinding {
|
|
14
|
+
attribute :>> id = "PMB-GPCA-001";
|
|
15
|
+
attribute :>> name = "GPCAProjectMethodBinding";
|
|
16
|
+
attribute :>> projectName = "GPCA Infusion Pump";
|
|
17
|
+
ref :>> selectedMethodology = gpcaMethodDefinition;
|
|
18
|
+
// The project adds nothing to the methodology's selection.
|
|
19
|
+
attribute :>> scopeMode = ScopeModeKind::explicit;
|
|
20
|
+
// The submission regimes this device targets. `memo standards check`
|
|
21
|
+
// reads this to decide which standards are required: an EU + US launch
|
|
22
|
+
// pulls in both the harmonised IEC/ISO packs and 21 CFR Part 820,
|
|
23
|
+
// where a CE-only project would not be asked for the FDA clauses.
|
|
24
|
+
attribute :>> regulatoryRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::FDA_510k);
|
|
25
|
+
}
|
|
26
|
+
}
|
|
@@ -0,0 +1,8 @@
|
|
|
1
|
+
// context viewpoint.
|
|
2
|
+
//
|
|
3
|
+
// This project does not define its own viewpoint here; it binds the reusable
|
|
4
|
+
// MEMO viewpoint that frames these concerns. The views it governs sit beneath
|
|
5
|
+
// `views/`.
|
|
6
|
+
package memo_examples_gpca_pump_viewpoints_context {
|
|
7
|
+
public import memo_viewpoints_context_context_viewpoint::*;
|
|
8
|
+
}
|
|
@@ -1,4 +1,4 @@
|
|
|
1
|
-
package
|
|
1
|
+
package memo_examples_gpca_pump_viewpoints_context_views_context_system_context_view {
|
|
2
2
|
private import ScalarValues::*;
|
|
3
3
|
|
|
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private import memo_viewpoints_definitions::*;
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@@ -14,13 +14,13 @@ package memo_examples_gpca_pump_model_views_context_system_context_view {
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private import memo_core_enumerations::*;
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view gpcaSystemContextView : MemoDiagramView {
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expose
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expose memo_examples_gpca_pump_viewpoints_context_views_context_system_context_view::*;
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attribute depth = 2;
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attribute :>> id = "VIEW-CTX-101";
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attribute :>> name = "GPCA_SystemContextView";
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attribute :>> title = "GPCA System Context View";
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attribute :>> shortDescription = "Actors, use contexts, and external entities at the GPCA system boundary.";
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attribute :>>
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attribute :>> description = "Shows the CriSys Fig 2.1 boundary: patient, clinician, prescription, drug reservoir, needle, hospital pharmacy database, and hospital environment around the pump, with directional data flows, physical drug-path connections, and the intended use anchoring the boundary.";
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attribute :>> outputKind = (ViewOutputKind::diagram);
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attribute :>> presentationKind = (PresentationKind::blockDiagram);
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attribute :>> viewKind = DiagramViewKind::general;
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@@ -33,7 +33,7 @@ package memo_examples_gpca_pump_model_views_context_system_context_view {
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attribute :>> id = "QRY-CTX-101";
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attribute :>> name = "GPCA_SystemContextQuery";
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attribute :>> includeElementKinds = ("Actor", "UseContext", "IntendedUse", "ReasonablyForeseeableMisuse", "OperationalEntity");
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attribute :>> includeRelationshipKinds = ("InteractsWith", "
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attribute :>> includeRelationshipKinds = ("InteractsWith", "flow", "connect", "Governs", "AppliesInContext");
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attribute :>> includeLayers = ("context", "operational");
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attribute :>> selectionExpression = "product == 'GPCA'";
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attribute :>> rationaleText = "Auto-populate the GPCA context view from the context layer.";
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// cybersecurity viewpoint.
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//
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// This project does not define its own viewpoint here; it binds the reusable
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// MEMO viewpoint that frames these concerns. The views it governs sit beneath
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// `views/`.
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package memo_examples_gpca_pump_viewpoints_cybersecurity {
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public import memo_viewpoints_cybersecurity_cybersecurity_viewpoint::*;
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}
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package
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package memo_examples_gpca_pump_viewpoints_cybersecurity_views_cybersecurity_cybersecurity_view {
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private import ScalarValues::*;
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private import memo_viewpoints_definitions::*;
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@@ -15,13 +15,13 @@ package memo_examples_gpca_pump_model_views_cybersecurity_cybersecurity_view {
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private import memo_core_enumerations::*;
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view gpcaCybersecurityView : MemoDiagramView {
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expose
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expose memo_examples_gpca_pump_viewpoints_cybersecurity_views_cybersecurity_cybersecurity_view::*;
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attribute depth = 2;
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attribute :>> id = "VIEW-CYB-001";
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attribute :>> name = "GPCA_CybersecurityView";
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attribute :>> title = "GPCA Cybersecurity View";
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attribute :>> shortDescription = "Shows GPCA assets, trust boundaries, threats, vulnerabilities, and mitigations.";
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attribute :>>
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attribute :>> description = "Product-specific cybersecurity view intended for secure product development and cross-reference into cybersecurity risk documentation.";
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attribute :>> outputKind = (ViewOutputKind::diagram);
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attribute :>> presentationKind = (PresentationKind::custom);
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attribute :>> viewKind = DiagramViewKind::general;
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@@ -33,7 +33,7 @@ package memo_examples_gpca_pump_model_views_cybersecurity_cybersecurity_view {
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part :>> selectionQuery {
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attribute :>> id = "QRY-CYB-001";
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attribute :>> name = "GPCA_CybersecurityQuery";
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attribute :>> includeElementKinds = ("CybersecurityAsset", "Threat", "Vulnerability", "CyberHazard", "CyberRisk", "CyberMitigation", "SecurityRequirement", "TrustBoundary", "
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attribute :>> includeElementKinds = ("CybersecurityAsset", "Threat", "Vulnerability", "CyberHazard", "CyberRisk", "CyberMitigation", "SecurityRequirement", "TrustBoundary", "MemoScenario[scenarioKind=threat]");
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attribute :>> includeLayers = ("cybersecurity", "risk", "assurance");
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attribute :>> includeConcerns = (ConcernKind::cybersecurity, ConcernKind::privacy, ConcernKind::safety);
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attribute :>> selectionExpression = "product == 'GPCA'";
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@@ -1,18 +1,18 @@
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package
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package memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_cyber_assessment_view {
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private import ScalarValues::*;
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private import memo_viewpoints_definitions::*;
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private import
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private import memo_viewpoints_cybersecurity_views_cybersecurity_assessment_view::*;
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private import memo_viewpoints_cybersecurity_cybersecurity_viewpoint::*;
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private import memo_core_enumerations::*;
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view cyberAssessmentView : MemoCybersecurityAssessmentView {
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expose
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expose memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_cyber_assessment_view::*;
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attribute :>> id = "DOC-003";
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attribute :>> name = "GPCAMemoCybersecurityAssessmentView";
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attribute :>> title = "GPCA Cybersecurity Assessment View";
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attribute :>> shortDescription = "Cybersecurity risk-assessment-oriented document view for GPCA.";
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attribute :>>
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attribute :>> description = "Captures GPCA cyber risks, mitigations, security requirements, verification, and safety/privacy traceability for cybersecurity assessment records.";
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attribute :>> version = "0.1";
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attribute :>> lifecycleState = LifecycleStateKind::development;
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attribute :>> marketScope = "generic";
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package memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_threat_model_view {
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private import
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private import memo_viewpoints_cybersecurity_views_threat_model_view::*;
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private import memo_viewpoints_cybersecurity_cybersecurity_viewpoint::*;
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view threatModelView : MemoCybersecurityThreatModelView {
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expose memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_threat_model_view::*;
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attribute :>> id = "DOC-002";
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attribute :>> name = "GPCACyberThreatModelView";
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attribute :>> title = "GPCA Cybersecurity Threat Model View";
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attribute :>> shortDescription = "Threat-model-oriented document view for GPCA.";
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attribute :>>
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attribute :>> description = "Captures GPCA cyber assets, trust boundaries, threats, threat scenarios, vulnerabilities, and mitigations for secure product development records.";
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attribute :>> version = "0.1";
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attribute :>> lifecycleState = LifecycleStateKind::development;
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attribute :>> marketScope = "generic";
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part :>> selectionQuery {
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attribute :>> id = "QRY-DOC-008";
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attribute :>> name = "threatModelViewQuery";
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attribute :>> includeElementKinds = ("Threat", "
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attribute :>> includeElementKinds = ("Threat", "MemoScenario[scenarioKind=threat]", "Vulnerability", "CybersecurityAsset", "TrustBoundary", "AttackSurface", "CyberMitigation", "SecurityRequirement");
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attribute :>> includeRelationshipKinds = ("ThreatenedBy", "Exploits", "RealizedByScenario", "CrossesTrustBoundary", "Mitigates", "DerivesCyberRequirement");
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attribute :>> rationaleText = "Declares what this document-backed view renders; the web renderer is presentation-only.";
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}
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// functional viewpoint.
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//
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// This project does not define its own viewpoint here; it binds the reusable
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// MEMO viewpoint that frames these concerns. The views it governs sit beneath
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// `views/`.
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package memo_examples_gpca_pump_viewpoints_functional {
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public import memo_viewpoints_functional_functional_viewpoint::*;
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}
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package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_allocation_view {
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private import memo_core_enumerations::*;
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view gpcaFunctionAllocationView : MemoDiagramView {
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expose memo_examples_gpca_pump_viewpoints_functional_views_functional_function_allocation_view::*;
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attribute depth = 2;
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attribute :>> id = "VIEW-FUN-102";
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attribute :>> name = "GPCA_FunctionAllocationView";
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package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_browser_view {
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view gpcaFunctionBrowserView : MemoDiagramView {
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expose memo_examples_gpca_pump_viewpoints_functional_views_functional_function_browser_view::*;
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attribute depth = 2;
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attribute :>> id = "VIEW-FUN-103";
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attribute :>> name = "GPCA_FunctionBrowserView";
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attribute :>> title = "GPCA Function Browser";
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attribute :>> shortDescription = "Membership tree over the functions layer: logical functions, flows, and the exchange item definitions, grouped by kind.";
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attribute :>>
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attribute :>> description = "Browser view (SysML v2 browser view kind) exposing the functions-layer membership hierarchy as a first-class view: the eleven logical functions, the logical flows connecting them, and the data/control definitions they exchange — with kind icons, expand/collapse, and filtering.";
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attribute :>> outputKind = (ViewOutputKind::diagram);
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attribute :>> presentationKind = (PresentationKind::blockDiagram);
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attribute :>> viewKind = DiagramViewKind::browser;
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// logical viewpoint.
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//
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// This project does not define its own viewpoint here; it binds the reusable
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// MEMO viewpoint that frames these concerns. The views it governs sit beneath
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// `views/`.
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package memo_examples_gpca_pump_viewpoints_logical {
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public import memo_viewpoints_logical_logical_viewpoint::*;
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}
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package memo_examples_gpca_pump_viewpoints_logical_views_behavior_action_flow_view {
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@@ -14,13 +14,13 @@ package memo_examples_gpca_pump_model_views_behavior_action_flow_view {
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view gpcaActionFlowView : MemoDiagramView {
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expose
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expose memo_examples_gpca_pump_viewpoints_logical_views_behavior_action_flow_view::*;
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attribute depth = 2;
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attribute :>> id = "VIEW-BHV-003";
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attribute :>> name = "GPCA_InfusionDeliveryActionFlowView";
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attribute :>> title = "GPCA Infusion Delivery Action Flow";
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attribute :>> shortDescription = "The 20 ms execution-step pipeline from sensor acquisition through alarm evaluation and dose limiting to pump actuation and event logging.";
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attribute :>>
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attribute :>> description = "Action flow over the infusionDeliveryFlow composite action: typed action steps with in/out parameters, item flows carrying the DD/CD exchange items, succession ordering from start to done, and swimlane allocation onto the logical architecture (sensors, alarm, infusion manager, pump motor, logging).";
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attribute :>> outputKind = (ViewOutputKind::diagram);
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attribute :>> presentationKind = (PresentationKind::activityDiagram);
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attribute :>> viewKind = DiagramViewKind::actionflow;
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