@memoarchitect/ontology 0.8.22 → 0.10.9
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 +1 -1
- package/examples/connected-patient-monitor/memo.package.yaml +3 -0
- package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +9 -7
- package/examples/connected-patient-monitor/model/catalog/project.sysml +3 -1
- package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/views/connected_patient_monitor_overview.sysml +1 -1
- package/examples/embedded-infusion-pump/memo.package.yaml +3 -0
- package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +11 -9
- package/examples/embedded-infusion-pump/model/catalog/project.sysml +3 -1
- package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/views/embedded_infusion_pump_overview.sysml +1 -1
- package/examples/functional-logical-physical/memo.package.yaml +3 -0
- package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +9 -7
- package/examples/functional-logical-physical/model/catalog/project.sysml +3 -1
- package/examples/functional-logical-physical/model/catalog/viewpoints/unassigned/views/functional_logical_physical_overview.sysml +1 -1
- package/examples/gpca-pump/memo.identity.yaml +2179 -0
- package/examples/gpca-pump/memo.package.yaml +3 -0
- package/examples/gpca-pump/methodology/gpca_profiles.sysml +3 -1
- package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +29 -27
- package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +115 -114
- package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +42 -41
- package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +26 -25
- package/examples/gpca-pump/model/catalog/gpca_context.sysml +27 -23
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +15 -15
- package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +42 -40
- package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +198 -197
- package/examples/gpca-pump/model/catalog/gpca_operational.sysml +146 -180
- package/examples/gpca-pump/model/catalog/gpca_physical.sysml +8 -6
- package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +290 -288
- package/examples/gpca-pump/model/catalog/gpca_risk.sysml +164 -163
- package/examples/gpca-pump/model/catalog/gpca_standards.sysml +44 -43
- package/examples/gpca-pump/model/catalog/gpca_system.sysml +21 -33
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +10 -11
- package/examples/gpca-pump/model/catalog/gpca_verification.sysml +62 -61
- package/examples/gpca-pump/model/catalog/project.sysml +3 -1
- package/examples/gpca-pump/model/catalog/viewpoints/context/views/context_system_context_view.sysml +7 -7
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/cybersecurity_cybersecurity_view.sysml +7 -7
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_cyber_assessment_view.sysml +6 -7
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_threat_model_view.sysml +7 -8
- package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_allocation_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_browser_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/behavior_action_flow_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/document_architecture_description_view.sysml +8 -9
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_device_interconnect_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_logical_architecture_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_mode_state_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_system_decomposition_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_scenario_sequence_view.sysml +7 -7
- package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_use_case_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/physical/views/physical_physical_bom_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/document_dhf_index_view.sysml +8 -9
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/requirements_requirements_trace_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_hazard_analysis_view.sysml +6 -7
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_rmf_view.sysml +6 -7
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_fmea_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_risk_chain_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/software/views/document_sdd_view.sysml +6 -7
- package/examples/gpca-pump/model/catalog/viewpoints/software/views/software_software_architecture_view.sysml +6 -6
- package/examples/gpca-pump/model/catalog/viewpoints/usability/views/document_usability_view.sysml +8 -9
- package/examples/gpca-pump/model/catalog/viewpoints/verification/views/document_vv_view.sysml +6 -7
- package/examples/gpca-pump/model/catalog/viewpoints/verification/views/verification_verification_coverage_view.sysml +6 -6
- package/examples/ivd-laboratory-system/memo.package.yaml +3 -0
- package/examples/ivd-laboratory-system/model/catalog/ivd_laboratory_system.sysml +10 -8
- package/examples/ivd-laboratory-system/model/catalog/project.sysml +3 -1
- package/examples/ivd-laboratory-system/model/catalog/viewpoints/unassigned/views/ivd_laboratory_system_overview.sysml +1 -1
- package/examples/manual-surgical-instrument/memo.package.yaml +3 -0
- package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +7 -5
- package/examples/manual-surgical-instrument/model/catalog/project.sysml +3 -1
- package/examples/manual-surgical-instrument/model/catalog/viewpoints/unassigned/views/manual_surgical_instrument_overview.sysml +1 -1
- package/examples/multidimensional-layers/memo.package.yaml +3 -0
- package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -4
- package/examples/multidimensional-layers/model/catalog/project.sysml +3 -1
- package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/views/multidimensional_layers_overview.sysml +0 -1
- package/examples/nested-architecture-dsm/memo.package.yaml +3 -0
- package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +20 -18
- package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +20 -18
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +6 -4
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +9 -7
- package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +18 -16
- package/examples/nested-architecture-dsm/model/catalog/project.sysml +3 -1
- package/examples/reusable-instrument/memo.package.yaml +3 -0
- package/examples/reusable-instrument/model/catalog/project.sysml +3 -1
- package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +23 -31
- package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/views/reusable_instrument_overview.sysml +0 -1
- package/examples/ros-mobile-robot/memo.package.yaml +3 -0
- package/examples/ros-mobile-robot/model/catalog/project.sysml +3 -1
- package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +18 -16
- package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/views/ros_mobile_robot_overview.sysml +0 -1
- package/examples/software-only-medical-device/memo.package.yaml +3 -0
- package/examples/software-only-medical-device/model/catalog/project.sysml +3 -1
- package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +11 -9
- package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/views/software_only_medical_device_overview.sysml +0 -1
- package/examples/surgical-closure-workflow/memo.package.yaml +3 -0
- package/examples/surgical-closure-workflow/model/catalog/project.sysml +3 -1
- package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +56 -69
- package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/views/surgical_closure_workflow_overview.sysml +0 -1
- package/examples/surgical-robot/memo.package.yaml +3 -0
- package/examples/surgical-robot/model/catalog/project.sysml +3 -1
- package/examples/surgical-robot/model/catalog/surgical_robot.sysml +9 -7
- package/examples/surgical-robot/model/catalog/viewpoints/unassigned/views/surgical_robot_overview.sysml +0 -1
- package/examples/sysml-diagram-samples/memo.package.yaml +2 -0
- package/examples/sysml-diagram-samples/model/catalog/project.sysml +3 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/action_flow_view.sysml +12 -11
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.sysml +8 -7
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +4 -3
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +3 -3
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +17 -16
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/requirements_view.sysml +9 -8
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +4 -3
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +3 -3
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +4 -3
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/use_case_view.sysml +12 -9
- package/examples/temperature-alarm/memo.identity.yaml +64 -0
- package/examples/temperature-alarm/memo.package.yaml +3 -0
- package/examples/temperature-alarm/model/catalog/project.sysml +3 -1
- package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +30 -29
- package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/views/temperature_alarm_overview.sysml +0 -1
- package/examples/ui-screen-regions/memo.package.yaml +3 -0
- package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +14 -12
- package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +35 -33
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +8 -6
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +14 -13
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +4 -2
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +4 -2
- package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +12 -10
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +3 -1
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +14 -12
- package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +17 -15
- package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +10 -9
- package/examples/ui-screen-regions/model/catalog/project.sysml +3 -1
- package/examples/ui-screen-regions/model/catalog/relationships.sysml +2 -2
- package/examples/ui-screen-regions/model/catalog/traces.sysml +0 -2
- package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +6 -5
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +6 -5
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +6 -5
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +4 -3
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +4 -3
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +4 -3
- package/extensions/aadl/memo.package.yaml +1 -1
- package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +23 -21
- package/extensions/aadl/src/methodology/aadl_methodology.sysml +3 -1
- package/extensions/clinical/src/methodology/clinical_methodology.sysml +3 -1
- package/extensions/cloud/memo.package.yaml +1 -1
- package/extensions/cloud/src/methodology/cloud_methodology.sysml +3 -1
- package/extensions/container/memo.package.yaml +1 -1
- package/extensions/container/src/container_extension.sysml +2 -2
- package/extensions/container/src/methodology/container_methodology.sysml +3 -1
- package/extensions/messaging/memo.package.yaml +1 -1
- package/extensions/messaging/src/methodology/messaging_methodology.sysml +3 -1
- package/extensions/ros/memo.package.yaml +1 -1
- package/extensions/ros/src/methodology/ros_methodology.sysml +3 -1
- package/extensions/template/src/extension.sysml +3 -1
- package/methodologies/default/memo.package.yaml +1 -1
- package/methodologies/gpca/memo.package.yaml +1 -1
- package/ontology/memo.package.yaml +1 -1
- package/package.json +2 -2
- package/profile/memo.package.yaml +1 -1
- package/src/architecture/functional/behavior/memo_behavior.sysml +5 -5
- package/src/architecture/functional/functions/memo_functions.sysml +6 -6
- package/src/architecture/implementation/hardware/common/memo_hardware_common.sysml +12 -2
- package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +0 -11
- package/src/architecture/implementation/software/structure/memo_software_structure.sysml +7 -7
- package/src/architecture/implementation/ui/memo_ui.sysml +8 -31
- package/src/architecture/logical/interfaces/memo_interfaces.sysml +4 -2
- package/src/architecture/logical/structure/memo_logical_structure.sysml +5 -5
- package/src/architecture/operational/activities/memo_activities.sysml +19 -28
- package/src/architecture/operational/context/actors/memo_actors.sysml +5 -4
- package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +7 -7
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +5 -14
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +12 -104
- package/src/architecture/operational/structure/memo_operational.sysml +42 -13
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +7 -12
- package/src/architecture/operational/workflows/memo_workflows.sysml +20 -42
- package/src/architecture/realization/deployment/memo_deployment.sysml +26 -19
- package/src/architecture/realization/physical/memo_physical_architecture.sysml +8 -2
- package/src/artifacts/standards/cfr_21_820.sysml +80 -89
- package/src/artifacts/standards/fda_cybersecurity_2023.sysml +45 -49
- package/src/artifacts/standards/iec_60601_1.sysml +108 -121
- package/src/artifacts/standards/iec_60601_1_2.sysml +31 -33
- package/src/artifacts/standards/iec_60812.sysml +21 -22
- package/src/artifacts/standards/iec_62304.sysml +150 -169
- package/src/artifacts/standards/iec_62366_1.sysml +80 -89
- package/src/artifacts/standards/iec_81001_5_1.sysml +52 -57
- package/src/artifacts/standards/iso_13485.sysml +80 -89
- package/src/artifacts/standards/iso_14971.sysml +66 -73
- package/src/artifacts/standards/iso_iec_ieee_42010.sysml +15 -15
- package/src/artifacts/templates/dhf/system/sad.md +3 -3
- package/src/assurance/cybersecurity/memo_cybersecurity.sysml +2 -2
- package/src/assurance/human_factors/memo_human_factors.sysml +2 -2
- package/src/assurance/requirements/memo_requirements.sysml +2 -18
- package/src/assurance/safety_risk/analysis/memo_fmea.sysml +1 -1
- package/src/assurance/safety_risk/memo_risk.sysml +12 -0
- package/src/assurance/verification_validation/memo_assurance.sysml +7 -12
- package/src/core/common/memo_common.sysml +59 -55
- package/src/core/enumerations/memo_enumerations.sysml +1 -1
- package/src/core/relationships/memo_relationships.sysml +29 -56
- package/src/methodology/archetypes/memo_archetypes.sysml +10 -8
- package/src/methodology/core/memo_core.sysml +0 -10
- package/src/methodology/profiles/memo_profiles.sysml +18 -16
- package/src/methodology/workflow/memo_workflow.sysml +5 -5
- package/src/rules/closure/closure_rules.sysml +22 -20
- package/src/rules/crosslayer/cross_layer_rules.sysml +4 -2
- package/src/rules/ontology/ontology_invariants.sysml +121 -48
- package/src/rules/quantitative/quantitative_rules.sysml +4 -2
- package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +58 -57
- package/src/viewpoints/clinical/clinical_viewpoint.sysml +5 -4
- package/src/viewpoints/context/context_viewpoint.sysml +6 -5
- package/src/viewpoints/context/views/system_context_view/system_context_view.sysml +6 -5
- package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +6 -6
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +36 -4
- package/src/viewpoints/functional/functional_viewpoint.sysml +6 -5
- package/src/viewpoints/functional/views/function_allocation_view/function_allocation_view.sysml +6 -5
- package/src/viewpoints/functional/views/system_functional_tree_view/system_functional_tree_view.sysml +6 -5
- package/src/viewpoints/logical/logical_viewpoint.sysml +5 -4
- package/src/viewpoints/logical/views/logical_architecture_view/logical_architecture_view.sysml +6 -5
- package/src/viewpoints/operational/operational_viewpoint.sysml +6 -5
- package/src/viewpoints/operational/views/use_case_view/use_case_view.sysml +7 -6
- package/src/viewpoints/physical/physical_viewpoint.sysml +5 -4
- package/src/viewpoints/physical/views/network_topology_view/network_topology_view.sysml +6 -5
- package/src/viewpoints/physical/views/physical_bom_view/physical_bom_view.sysml +6 -5
- package/src/viewpoints/rendering/memo_rendering.sysml +220 -40
- package/src/viewpoints/requirements/requirements_viewpoint.sysml +5 -4
- package/src/viewpoints/requirements/views/requirements_traceability_view/requirements_traceability_view.sysml +6 -5
- package/src/viewpoints/risk/risk_viewpoint.sysml +5 -4
- package/src/viewpoints/risk/views/risk_chain_view/risk_chain_view.sysml +6 -5
- package/src/viewpoints/software/software_viewpoint.sysml +5 -4
- package/src/viewpoints/software/views/software_architecture_view/software_architecture_view.sysml +6 -5
- package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +5 -4
- package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +3 -1
- package/src/viewpoints/usability/usability_viewpoint.sysml +5 -4
- package/src/viewpoints/verification/verification_viewpoint.sysml +5 -4
- package/src/viewpoints/verification/views/verification_coverage_view/verification_coverage_view.sysml +6 -5
- package/templates/connected-device/memo.package.yaml +2 -0
- package/templates/connected-device/model/catalog/project.sysml +3 -1
- package/templates/default/memo.package.yaml +2 -0
- package/templates/default/model/catalog/project.sysml +3 -1
- package/templates/infusion-pump/memo.package.yaml +2 -0
- package/templates/infusion-pump/model/catalog/project.sysml +3 -1
- package/templates/monitoring-device/memo.package.yaml +2 -0
- package/templates/monitoring-device/model/catalog/project.sysml +3 -1
- package/templates/samd/memo.package.yaml +2 -0
- package/templates/samd/model/catalog/project.sysml +3 -1
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@@ -10,104 +10,95 @@ package memo_artifacts_standards_iso_13485 {
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private import memo_core_relationships::*;
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private import memo_artifacts_standards_traceability::*;
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private import memo_core_common::*;
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private import memo_core_common::MemoIdentity;
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item iso13485 : RegulatoryStandard {
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-
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@MemoIdentity { :>> providedId = "STD-ISO-13485"; }
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attribute :>> name = "ISO13485";
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attribute :>> designation = "ISO 13485:2016";
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attribute :>> edition = "2016";
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attribute :>> issuer = "ISO";
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attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
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item iso13485Clause4 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-4"; }
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attribute :>> name = "ISO13485Clause4";
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attribute :>> clauseNumber = "4";
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attribute :>> title = "quality management system";
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attribute :>> normativeStrength = "shall";
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item iso13485Clause4_2 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-4-2"; }
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attribute :>> name = "ISO13485Clause4_2";
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attribute :>> clauseNumber = "4.2";
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attribute :>> title = "quality management system documentation";
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attribute :>> normativeStrength = "shall";
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item iso13485Clause4_2_4 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-4-2-4"; }
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attribute :>> name = "ISO13485Clause4_2_4";
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attribute :>> clauseNumber = "4.2.4";
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attribute :>> title = "control of documents";
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attribute :>> normativeStrength = "shall";
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}
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}
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}
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item iso13485Clause7 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7"; }
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attribute :>> name = "ISO13485Clause7";
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attribute :>> clauseNumber = "7";
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attribute :>> title = "product realization";
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attribute :>> normativeStrength = "shall";
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item iso13485Clause7_3 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3"; }
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attribute :>> name = "ISO13485Clause7_3";
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attribute :>> clauseNumber = "7.3";
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attribute :>> title = "design and development";
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attribute :>> normativeStrength = "shall";
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item iso13485Clause7_3_3 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-3"; }
|
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attribute :>> name = "ISO13485Clause7_3_3";
|
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attribute :>> clauseNumber = "7.3.3";
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attribute :>> title = "design and development inputs";
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attribute :>> normativeStrength = "shall";
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}
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item iso13485Clause7_3_4 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-4"; }
|
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|
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attribute :>> name = "ISO13485Clause7_3_4";
|
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attribute :>> clauseNumber = "7.3.4";
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attribute :>> title = "design and development outputs";
|
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attribute :>> normativeStrength = "shall";
|
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}
|
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|
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item iso13485Clause7_3_6 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-6"; }
|
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attribute :>> name = "ISO13485Clause7_3_6";
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attribute :>> clauseNumber = "7.3.6";
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attribute :>> title = "design and development verification";
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attribute :>> normativeStrength = "shall";
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}
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item iso13485Clause7_3_7 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-7"; }
|
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attribute :>> name = "ISO13485Clause7_3_7";
|
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attribute :>> clauseNumber = "7.3.7";
|
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attribute :>> title = "design and development validation";
|
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attribute :>> normativeStrength = "shall";
|
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}
|
|
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|
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item iso13485Clause7_3_9 : StandardClause {
|
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|
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@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-9"; }
|
|
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|
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attribute :>> name = "ISO13485Clause7_3_9";
|
|
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|
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attribute :>> clauseNumber = "7.3.9";
|
|
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|
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attribute :>> title = "control of design and development changes";
|
|
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|
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attribute :>> normativeStrength = "shall";
|
|
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|
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}
|
|
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|
+
item iso13485Clause7_3_10 : StandardClause {
|
|
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|
+
@MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-10"; }
|
|
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|
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attribute :>> name = "ISO13485Clause7_3_10";
|
|
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|
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attribute :>> clauseNumber = "7.3.10";
|
|
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|
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attribute :>> title = "design and development files";
|
|
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|
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attribute :>> normativeStrength = "shall";
|
|
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|
+
}
|
|
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|
+
}
|
|
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|
+
}
|
|
20
99
|
}
|
|
21
100
|
|
|
22
|
-
item iso13485Clause4 : StandardClause {
|
|
23
|
-
attribute :>> id = "STD-ISO-13485-4";
|
|
24
|
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attribute :>> name = "ISO13485Clause4";
|
|
25
|
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attribute :>> clauseNumber = "4";
|
|
26
|
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attribute :>> title = "quality management system";
|
|
27
|
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attribute :>> normativeStrength = "shall";
|
|
28
|
-
}
|
|
29
|
-
item iso13485Clause4_2 : StandardClause {
|
|
30
|
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attribute :>> id = "STD-ISO-13485-4-2";
|
|
31
|
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attribute :>> name = "ISO13485Clause4_2";
|
|
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|
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attribute :>> clauseNumber = "4.2";
|
|
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|
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attribute :>> title = "quality management system documentation";
|
|
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|
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attribute :>> normativeStrength = "shall";
|
|
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|
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}
|
|
36
|
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item iso13485Clause4_2_4 : StandardClause {
|
|
37
|
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attribute :>> id = "STD-ISO-13485-4-2-4";
|
|
38
|
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attribute :>> name = "ISO13485Clause4_2_4";
|
|
39
|
-
attribute :>> clauseNumber = "4.2.4";
|
|
40
|
-
attribute :>> title = "control of documents";
|
|
41
|
-
attribute :>> normativeStrength = "shall";
|
|
42
|
-
}
|
|
43
|
-
item iso13485Clause7 : StandardClause {
|
|
44
|
-
attribute :>> id = "STD-ISO-13485-7";
|
|
45
|
-
attribute :>> name = "ISO13485Clause7";
|
|
46
|
-
attribute :>> clauseNumber = "7";
|
|
47
|
-
attribute :>> title = "product realization";
|
|
48
|
-
attribute :>> normativeStrength = "shall";
|
|
49
|
-
}
|
|
50
|
-
item iso13485Clause7_3 : StandardClause {
|
|
51
|
-
attribute :>> id = "STD-ISO-13485-7-3";
|
|
52
|
-
attribute :>> name = "ISO13485Clause7_3";
|
|
53
|
-
attribute :>> clauseNumber = "7.3";
|
|
54
|
-
attribute :>> title = "design and development";
|
|
55
|
-
attribute :>> normativeStrength = "shall";
|
|
56
|
-
}
|
|
57
|
-
item iso13485Clause7_3_3 : StandardClause {
|
|
58
|
-
attribute :>> id = "STD-ISO-13485-7-3-3";
|
|
59
|
-
attribute :>> name = "ISO13485Clause7_3_3";
|
|
60
|
-
attribute :>> clauseNumber = "7.3.3";
|
|
61
|
-
attribute :>> title = "design and development inputs";
|
|
62
|
-
attribute :>> normativeStrength = "shall";
|
|
63
|
-
}
|
|
64
|
-
item iso13485Clause7_3_4 : StandardClause {
|
|
65
|
-
attribute :>> id = "STD-ISO-13485-7-3-4";
|
|
66
|
-
attribute :>> name = "ISO13485Clause7_3_4";
|
|
67
|
-
attribute :>> clauseNumber = "7.3.4";
|
|
68
|
-
attribute :>> title = "design and development outputs";
|
|
69
|
-
attribute :>> normativeStrength = "shall";
|
|
70
|
-
}
|
|
71
|
-
item iso13485Clause7_3_6 : StandardClause {
|
|
72
|
-
attribute :>> id = "STD-ISO-13485-7-3-6";
|
|
73
|
-
attribute :>> name = "ISO13485Clause7_3_6";
|
|
74
|
-
attribute :>> clauseNumber = "7.3.6";
|
|
75
|
-
attribute :>> title = "design and development verification";
|
|
76
|
-
attribute :>> normativeStrength = "shall";
|
|
77
|
-
}
|
|
78
|
-
item iso13485Clause7_3_7 : StandardClause {
|
|
79
|
-
attribute :>> id = "STD-ISO-13485-7-3-7";
|
|
80
|
-
attribute :>> name = "ISO13485Clause7_3_7";
|
|
81
|
-
attribute :>> clauseNumber = "7.3.7";
|
|
82
|
-
attribute :>> title = "design and development validation";
|
|
83
|
-
attribute :>> normativeStrength = "shall";
|
|
84
|
-
}
|
|
85
|
-
item iso13485Clause7_3_9 : StandardClause {
|
|
86
|
-
attribute :>> id = "STD-ISO-13485-7-3-9";
|
|
87
|
-
attribute :>> name = "ISO13485Clause7_3_9";
|
|
88
|
-
attribute :>> clauseNumber = "7.3.9";
|
|
89
|
-
attribute :>> title = "control of design and development changes";
|
|
90
|
-
attribute :>> normativeStrength = "shall";
|
|
91
|
-
}
|
|
92
|
-
item iso13485Clause7_3_10 : StandardClause {
|
|
93
|
-
attribute :>> id = "STD-ISO-13485-7-3-10";
|
|
94
|
-
attribute :>> name = "ISO13485Clause7_3_10";
|
|
95
|
-
attribute :>> clauseNumber = "7.3.10";
|
|
96
|
-
attribute :>> title = "design and development files";
|
|
97
|
-
attribute :>> normativeStrength = "shall";
|
|
98
|
-
}
|
|
99
101
|
|
|
100
|
-
connection iso13485Has4 : Composes connect parent ::> iso13485 to child ::> iso13485Clause4;
|
|
101
|
-
connection iso13485Has7 : Composes connect parent ::> iso13485 to child ::> iso13485Clause7;
|
|
102
102
|
|
|
103
|
-
connection iso13485Has4_2 : Composes connect parent ::> iso13485Clause4 to child ::> iso13485Clause4_2;
|
|
104
|
-
connection iso13485Has4_2_4 : Composes connect parent ::> iso13485Clause4_2 to child ::> iso13485Clause4_2_4;
|
|
105
103
|
|
|
106
|
-
connection iso13485Has7_3 : Composes connect parent ::> iso13485Clause7 to child ::> iso13485Clause7_3;
|
|
107
|
-
connection iso13485Has7_3_3 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_3;
|
|
108
|
-
connection iso13485Has7_3_4 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_4;
|
|
109
|
-
connection iso13485Has7_3_6 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_6;
|
|
110
|
-
connection iso13485Has7_3_7 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_7;
|
|
111
|
-
connection iso13485Has7_3_9 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_9;
|
|
112
|
-
connection iso13485Has7_3_10 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_10;
|
|
113
104
|
}
|
|
@@ -8,87 +8,80 @@ package memo_artifacts_standards_iso_14971 {
|
|
|
8
8
|
private import memo_core_relationships::*;
|
|
9
9
|
private import memo_artifacts_standards_traceability::*;
|
|
10
10
|
|
|
11
|
+
private import memo_core_common::*;
|
|
12
|
+
private import memo_core_common::MemoIdentity;
|
|
11
13
|
item iso14971 : RegulatoryStandard {
|
|
12
|
-
|
|
14
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971"; }
|
|
13
15
|
attribute :>> name = "ISO14971";
|
|
14
16
|
attribute :>> designation = "ISO 14971:2019";
|
|
15
17
|
attribute :>> edition = "2019";
|
|
16
18
|
attribute :>> issuer = "ISO";
|
|
17
19
|
attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
|
|
20
|
+
item iso14971Clause4 : StandardClause {
|
|
21
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-4"; }
|
|
22
|
+
attribute :>> name = "ISO14971Clause4";
|
|
23
|
+
attribute :>> clauseNumber = "4";
|
|
24
|
+
attribute :>> title = "general requirements for the risk management system";
|
|
25
|
+
attribute :>> normativeStrength = "shall";
|
|
26
|
+
item iso14971Clause4_4 : StandardClause {
|
|
27
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-4-4"; }
|
|
28
|
+
attribute :>> name = "ISO14971Clause4_4";
|
|
29
|
+
attribute :>> clauseNumber = "4.4";
|
|
30
|
+
attribute :>> title = "risk management plan";
|
|
31
|
+
attribute :>> normativeStrength = "shall";
|
|
32
|
+
}
|
|
33
|
+
item iso14971Clause4_5 : StandardClause {
|
|
34
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-4-5"; }
|
|
35
|
+
attribute :>> name = "ISO14971Clause4_5";
|
|
36
|
+
attribute :>> clauseNumber = "4.5";
|
|
37
|
+
attribute :>> title = "risk management file";
|
|
38
|
+
attribute :>> normativeStrength = "shall";
|
|
39
|
+
}
|
|
40
|
+
}
|
|
41
|
+
item iso14971Clause5 : StandardClause {
|
|
42
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-5"; }
|
|
43
|
+
attribute :>> name = "ISO14971Clause5";
|
|
44
|
+
attribute :>> clauseNumber = "5";
|
|
45
|
+
attribute :>> title = "risk analysis";
|
|
46
|
+
attribute :>> normativeStrength = "shall";
|
|
47
|
+
}
|
|
48
|
+
item iso14971Clause6 : StandardClause {
|
|
49
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-6"; }
|
|
50
|
+
attribute :>> name = "ISO14971Clause6";
|
|
51
|
+
attribute :>> clauseNumber = "6";
|
|
52
|
+
attribute :>> title = "risk evaluation";
|
|
53
|
+
attribute :>> normativeStrength = "shall";
|
|
54
|
+
}
|
|
55
|
+
item iso14971Clause7 : StandardClause {
|
|
56
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-7"; }
|
|
57
|
+
attribute :>> name = "ISO14971Clause7";
|
|
58
|
+
attribute :>> clauseNumber = "7";
|
|
59
|
+
attribute :>> title = "risk control";
|
|
60
|
+
attribute :>> normativeStrength = "shall";
|
|
61
|
+
}
|
|
62
|
+
item iso14971Clause8 : StandardClause {
|
|
63
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-8"; }
|
|
64
|
+
attribute :>> name = "ISO14971Clause8";
|
|
65
|
+
attribute :>> clauseNumber = "8";
|
|
66
|
+
attribute :>> title = "evaluation of overall residual risk";
|
|
67
|
+
attribute :>> normativeStrength = "shall";
|
|
68
|
+
}
|
|
69
|
+
item iso14971Clause9 : StandardClause {
|
|
70
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-9"; }
|
|
71
|
+
attribute :>> name = "ISO14971Clause9";
|
|
72
|
+
attribute :>> clauseNumber = "9";
|
|
73
|
+
attribute :>> title = "risk management review";
|
|
74
|
+
attribute :>> normativeStrength = "shall";
|
|
75
|
+
}
|
|
76
|
+
item iso14971Clause10 : StandardClause {
|
|
77
|
+
@MemoIdentity { :>> providedId = "STD-ISO-14971-10"; }
|
|
78
|
+
attribute :>> name = "ISO14971Clause10";
|
|
79
|
+
attribute :>> clauseNumber = "10";
|
|
80
|
+
attribute :>> title = "production and post-production activities";
|
|
81
|
+
attribute :>> normativeStrength = "shall";
|
|
82
|
+
}
|
|
18
83
|
}
|
|
19
84
|
|
|
20
|
-
item iso14971Clause4 : StandardClause {
|
|
21
|
-
attribute :>> id = "STD-ISO-14971-4";
|
|
22
|
-
attribute :>> name = "ISO14971Clause4";
|
|
23
|
-
attribute :>> clauseNumber = "4";
|
|
24
|
-
attribute :>> title = "general requirements for the risk management system";
|
|
25
|
-
attribute :>> normativeStrength = "shall";
|
|
26
|
-
}
|
|
27
|
-
item iso14971Clause4_4 : StandardClause {
|
|
28
|
-
attribute :>> id = "STD-ISO-14971-4-4";
|
|
29
|
-
attribute :>> name = "ISO14971Clause4_4";
|
|
30
|
-
attribute :>> clauseNumber = "4.4";
|
|
31
|
-
attribute :>> title = "risk management plan";
|
|
32
|
-
attribute :>> normativeStrength = "shall";
|
|
33
|
-
}
|
|
34
|
-
item iso14971Clause4_5 : StandardClause {
|
|
35
|
-
attribute :>> id = "STD-ISO-14971-4-5";
|
|
36
|
-
attribute :>> name = "ISO14971Clause4_5";
|
|
37
|
-
attribute :>> clauseNumber = "4.5";
|
|
38
|
-
attribute :>> title = "risk management file";
|
|
39
|
-
attribute :>> normativeStrength = "shall";
|
|
40
|
-
}
|
|
41
|
-
item iso14971Clause5 : StandardClause {
|
|
42
|
-
attribute :>> id = "STD-ISO-14971-5";
|
|
43
|
-
attribute :>> name = "ISO14971Clause5";
|
|
44
|
-
attribute :>> clauseNumber = "5";
|
|
45
|
-
attribute :>> title = "risk analysis";
|
|
46
|
-
attribute :>> normativeStrength = "shall";
|
|
47
|
-
}
|
|
48
|
-
item iso14971Clause6 : StandardClause {
|
|
49
|
-
attribute :>> id = "STD-ISO-14971-6";
|
|
50
|
-
attribute :>> name = "ISO14971Clause6";
|
|
51
|
-
attribute :>> clauseNumber = "6";
|
|
52
|
-
attribute :>> title = "risk evaluation";
|
|
53
|
-
attribute :>> normativeStrength = "shall";
|
|
54
|
-
}
|
|
55
|
-
item iso14971Clause7 : StandardClause {
|
|
56
|
-
attribute :>> id = "STD-ISO-14971-7";
|
|
57
|
-
attribute :>> name = "ISO14971Clause7";
|
|
58
|
-
attribute :>> clauseNumber = "7";
|
|
59
|
-
attribute :>> title = "risk control";
|
|
60
|
-
attribute :>> normativeStrength = "shall";
|
|
61
|
-
}
|
|
62
|
-
item iso14971Clause8 : StandardClause {
|
|
63
|
-
attribute :>> id = "STD-ISO-14971-8";
|
|
64
|
-
attribute :>> name = "ISO14971Clause8";
|
|
65
|
-
attribute :>> clauseNumber = "8";
|
|
66
|
-
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attribute :>> normativeStrength = "shall";
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}
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item iso14971Clause9 : StandardClause {
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attribute :>> id = "STD-ISO-14971-9";
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attribute :>> name = "ISO14971Clause9";
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attribute :>> clauseNumber = "9";
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}
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item iso14971Clause10 : StandardClause {
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}
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connection iso14971Has4 : Composes connect parent ::> iso14971 to child ::> iso14971Clause4;
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connection iso14971Has5 : Composes connect parent ::> iso14971 to child ::> iso14971Clause5;
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connection iso14971Has6 : Composes connect parent ::> iso14971 to child ::> iso14971Clause6;
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connection iso14971Has7 : Composes connect parent ::> iso14971 to child ::> iso14971Clause7;
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connection iso14971Has8 : Composes connect parent ::> iso14971 to child ::> iso14971Clause8;
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connection iso14971Has9 : Composes connect parent ::> iso14971 to child ::> iso14971Clause9;
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connection iso14971Has10 : Composes connect parent ::> iso14971 to child ::> iso14971Clause10;
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connection iso14971Has4_4 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_4;
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connection iso14971Has4_5 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_5;
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}
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@@ -12,8 +12,10 @@ package memo_artifacts_standards_iso_iec_ieee_42010 {
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private import memo_core_relationships::*;
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private import memo_artifacts_standards_traceability::*;
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14
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+
private import memo_core_common::*;
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+
private import memo_core_common::MemoIdentity;
|
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17
|
item isoIecIeee42010 : RegulatoryStandard {
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-
|
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|
+
@MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010"; }
|
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19
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attribute :>> name = "ISOIECIEEE42010";
|
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20
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attribute :>> designation = "ISO/IEC/IEEE 42010:2022";
|
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attribute :>> edition = "2022";
|
|
@@ -22,21 +24,19 @@ package memo_artifacts_standards_iso_iec_ieee_42010 {
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22
24
|
// reference standard, cited by documents rather than required by a
|
|
23
25
|
// market. Empty is the authored value, not an omission — see
|
|
24
26
|
// appliesToRegime in memo_artifacts_standards_traceability.
|
|
27
|
+
item isoIecIeee42010Clause5 : StandardClause {
|
|
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|
+
@MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010-5"; }
|
|
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|
+
attribute :>> name = "ISOIECIEEE42010Clause5";
|
|
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|
+
attribute :>> clauseNumber = "5";
|
|
31
|
+
attribute :>> normativeStrength = "shall";
|
|
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|
+
}
|
|
33
|
+
item isoIecIeee42010Clause6 : StandardClause {
|
|
34
|
+
@MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010-6"; }
|
|
35
|
+
attribute :>> name = "ISOIECIEEE42010Clause6";
|
|
36
|
+
attribute :>> clauseNumber = "6";
|
|
37
|
+
attribute :>> normativeStrength = "shall";
|
|
38
|
+
}
|
|
25
39
|
}
|
|
26
40
|
|
|
27
|
-
item isoIecIeee42010Clause5 : StandardClause {
|
|
28
|
-
attribute :>> id = "STD-ISO-IEC-IEEE-42010-5";
|
|
29
|
-
attribute :>> name = "ISOIECIEEE42010Clause5";
|
|
30
|
-
attribute :>> clauseNumber = "5";
|
|
31
|
-
attribute :>> normativeStrength = "shall";
|
|
32
|
-
}
|
|
33
|
-
item isoIecIeee42010Clause6 : StandardClause {
|
|
34
|
-
attribute :>> id = "STD-ISO-IEC-IEEE-42010-6";
|
|
35
|
-
attribute :>> name = "ISOIECIEEE42010Clause6";
|
|
36
|
-
attribute :>> clauseNumber = "6";
|
|
37
|
-
attribute :>> normativeStrength = "shall";
|
|
38
|
-
}
|
|
39
41
|
|
|
40
|
-
connection isoIecIeee42010Has5 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause5;
|
|
41
|
-
connection isoIecIeee42010Has6 : Composes connect parent ::> isoIecIeee42010 to child ::> isoIecIeee42010Clause6;
|
|
42
42
|
}
|
|
@@ -75,7 +75,7 @@ Runtime behaviour: the components executing in the system and the connectors thr
|
|
|
75
75
|
#### 3.2.1 Runtime Environments
|
|
76
76
|
|
|
77
77
|
```memo-query
|
|
78
|
-
kind: [RuntimeEnvironment,
|
|
78
|
+
kind: [RuntimeEnvironment, SoftwareDeploymentUnit]
|
|
79
79
|
display: table
|
|
80
80
|
columns: name, layer, doc
|
|
81
81
|
sort: name
|
|
@@ -101,12 +101,12 @@ Software elements mapped to their execution environments.
|
|
|
101
101
|
#### 3.3.1 Deployment Units
|
|
102
102
|
|
|
103
103
|
```memo-query
|
|
104
|
-
kind:
|
|
104
|
+
kind: SoftwareDeploymentUnit
|
|
105
105
|
traverse: outgoing deploysTo
|
|
106
106
|
display: table
|
|
107
107
|
columns: name, kind, layer, doc
|
|
108
108
|
sort: name
|
|
109
|
-
empty: "No deployments defined. Add DeploysTo links from
|
|
109
|
+
empty: "No deployments defined. Add DeploysTo links from SoftwareDeploymentUnit to the processing node."
|
|
110
110
|
```
|
|
111
111
|
|
|
112
112
|
---
|
|
@@ -10,7 +10,7 @@ package memo_assurance_cybersecurity {
|
|
|
10
10
|
private import memo_assurance_verification_validation::*;
|
|
11
11
|
private import memo_architecture_operational_scenarios::*;
|
|
12
12
|
|
|
13
|
-
part def CybersecurityAsset specializes
|
|
13
|
+
part def CybersecurityAsset specializes MemoPart {
|
|
14
14
|
attribute assetKind : AssetKind;
|
|
15
15
|
attribute confidentialityNeed : String;
|
|
16
16
|
attribute integrityNeed : String;
|
|
@@ -99,7 +99,7 @@ package memo_assurance_cybersecurity {
|
|
|
99
99
|
}
|
|
100
100
|
connection def RealizedByScenario :> MemoRelationship {
|
|
101
101
|
end realizedThreat : RequirementDriver :>> source;
|
|
102
|
-
end scenario :
|
|
102
|
+
end scenario : OperativeScenario :>> target;
|
|
103
103
|
}
|
|
104
104
|
abstract connection realizedByScenarioLinks : RealizedByScenario[*];
|
|
105
105
|
metadata def <realizedByScenario> RealizedByScenarioMetadata :> SemanticMetadata {
|
|
@@ -21,7 +21,7 @@ package memo_assurance_human_factors {
|
|
|
21
21
|
}
|
|
22
22
|
|
|
23
23
|
connection def CommitsUseError :> MemoRelationship {
|
|
24
|
-
end task :
|
|
24
|
+
end task : OperativeAction :>> source;
|
|
25
25
|
end useError : UseError :>> target;
|
|
26
26
|
}
|
|
27
27
|
abstract connection commitsUseErrorLinks : CommitsUseError[*];
|
|
@@ -32,7 +32,7 @@ package memo_assurance_human_factors {
|
|
|
32
32
|
}
|
|
33
33
|
connection def EvaluatesTask :> MemoRelationship {
|
|
34
34
|
end evaluation : MemoEvidence :>> source;
|
|
35
|
-
end task :
|
|
35
|
+
end task : OperativeAction :>> target;
|
|
36
36
|
}
|
|
37
37
|
abstract connection evaluatesTaskLinks : EvaluatesTask[*];
|
|
38
38
|
metadata def <evaluatesTask> EvaluatesTaskMetadata :> SemanticMetadata {
|
|
@@ -7,22 +7,6 @@ package memo_assurance_requirements {
|
|
|
7
7
|
private import memo_assurance_requirements_needs::*;
|
|
8
8
|
part def RiskDriver specializes RequirementDriver { attribute driverKind : String; }
|
|
9
9
|
|
|
10
|
-
// ISO 14971 risk-analysis inputs. These are model elements so hazards,
|
|
11
|
-
// scenarios, requirements, and DHF records can trace to the exact use
|
|
12
|
-
// definition or foreseeable misuse that motivated them.
|
|
13
|
-
part def IntendedUse specializes DocumentedElement {
|
|
14
|
-
attribute indication : String;
|
|
15
|
-
attribute contraindication : String;
|
|
16
|
-
attribute patientPopulation : String;
|
|
17
|
-
attribute clinicalBenefit : String;
|
|
18
|
-
attribute regulatoryClassification : String;
|
|
19
|
-
}
|
|
20
|
-
part def ReasonablyForeseeableMisuse specializes DocumentedElement {
|
|
21
|
-
attribute misuseContext : String;
|
|
22
|
-
attribute foreseeableBasis : String;
|
|
23
|
-
attribute affectedUseContext : String;
|
|
24
|
-
}
|
|
25
|
-
|
|
26
10
|
// The kind of requirement. Was a subclass branch (SystemRequirement /
|
|
27
11
|
// SoftwareRequirement / HardwareRequirement) plus a parallel design-control
|
|
28
12
|
// specification hierarchy (DesignControlSpecification / System- / Software- /
|
|
@@ -42,14 +26,14 @@ package memo_assurance_requirements {
|
|
|
42
26
|
|
|
43
27
|
requirement def Requirement specializes MemoRequirement {
|
|
44
28
|
attribute requirementKind : RequirementKind;
|
|
45
|
-
attribute statement : String;
|
|
29
|
+
attribute :>> statement : String;
|
|
46
30
|
attribute sourceKind : RequirementSourceKind;
|
|
47
31
|
attribute concernKind : ConcernKind;
|
|
48
32
|
// Editorial state is the inherited `status : ElementStatusKind` — the
|
|
49
33
|
// one status vocabulary in MEMO. Whether a requirement is implemented,
|
|
50
34
|
// verified, or validated is read from its Realizes / VerifiedBy /
|
|
51
35
|
// Validates links, not restated here.
|
|
52
|
-
attribute acceptanceCriteria : String;
|
|
36
|
+
attribute :>> acceptanceCriteria : String;
|
|
53
37
|
attribute subjectDescription : String;
|
|
54
38
|
attribute actorDescription : String;
|
|
55
39
|
attribute assumptionSummary : String;
|
|
@@ -184,7 +184,7 @@ package memo_assurance_safety_risk_analysis {
|
|
|
184
184
|
:>> baseType = identifiesHazardLinks meta SysML::Usage;
|
|
185
185
|
}
|
|
186
186
|
connection def HasFailureMode :> MemoRelationship {
|
|
187
|
-
end element :
|
|
187
|
+
end element : MemoPart :>> source;
|
|
188
188
|
end failureMode : FailureMode :>> target;
|
|
189
189
|
}
|
|
190
190
|
abstract connection hasFailureModeLinks : HasFailureMode[*];
|
|
@@ -6,6 +6,18 @@ package memo_assurance_safety_risk {
|
|
|
6
6
|
private import memo_core_common::*;
|
|
7
7
|
private import memo_core_enumerations::*;
|
|
8
8
|
private import memo_assurance_requirements::*;
|
|
9
|
+
|
|
10
|
+
// ISO 14971 / IEC 62366-1 risk-analysis input. A model element so hazards,
|
|
11
|
+
// scenarios, requirements, and DHF records can trace to the foreseeable
|
|
12
|
+
// misuse that motivated them. Its counterpart, IntendedUse, is now the
|
|
13
|
+
// operational-world root (memo_architecture_operational_structure::IntendedUse,
|
|
14
|
+
// a MemoMission).
|
|
15
|
+
part def ReasonablyForeseeableMisuse specializes MemoPart {
|
|
16
|
+
attribute misuseContext : String;
|
|
17
|
+
attribute foreseeableBasis : String;
|
|
18
|
+
attribute affectedUseContext : String;
|
|
19
|
+
}
|
|
20
|
+
|
|
9
21
|
part def Risk specializes RiskDriver {
|
|
10
22
|
attribute probabilityEstimate : ProbabilityKind;
|
|
11
23
|
attribute severityEstimate : SeverityKind;
|
|
@@ -19,8 +19,10 @@ package memo_assurance_verification_validation {
|
|
|
19
19
|
// EXECUTION state, not an editorial one; execution state belongs in an
|
|
20
20
|
// attribute of its own (see RiskControlMeasure.verificationStatus), not in
|
|
21
21
|
// a second spelling of `status`.
|
|
22
|
-
verification
|
|
23
|
-
|
|
22
|
+
// Specializes the standard library verification case as well as MEMO's
|
|
23
|
+
// base, rather than shadowing it — see the note on UseCase.
|
|
24
|
+
verification def VerificationCase :> MemoVerificationCase, VerificationCases::VerificationCase {
|
|
25
|
+
attribute methodKind : MemoVerificationMethodKind;
|
|
24
26
|
attribute acceptanceCriteria : String;
|
|
25
27
|
}
|
|
26
28
|
verification def ValidationCase :> MemoVerificationCase {
|
|
@@ -32,14 +34,7 @@ package memo_assurance_verification_validation {
|
|
|
32
34
|
// Operational validation confirms the user's goal is achieved in the
|
|
33
35
|
// use environment (§5): ValidationCase validates a UseCase.
|
|
34
36
|
// Safety-critical functions must trace to verification (rules/coverage).
|
|
35
|
-
|
|
36
|
-
|
|
37
|
-
|
|
38
|
-
}
|
|
39
|
-
abstract connection executesScenarioLinks : ExecutesScenario[*];
|
|
40
|
-
metadata def <executesScenario> ExecutesScenarioMetadata :> SemanticMetadata {
|
|
41
|
-
:> annotatedElement : SysML::ConnectionDefinition;
|
|
42
|
-
:> annotatedElement : SysML::ConnectionUsage;
|
|
43
|
-
:>> baseType = executesScenarioLinks meta SysML::Usage;
|
|
44
|
-
}
|
|
37
|
+
// `ExecutesScenario` is native `perform` (2026-08-18): OperativeScenario
|
|
38
|
+
// is an `action def`, so write `perform <scenario>;` inside the
|
|
39
|
+
// verification case, as `InvolvesFunction` already does.
|
|
45
40
|
}
|