@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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@@ -15,135 +15,122 @@ package memo_artifacts_standards_iec_60601_1 {
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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 iec60601_1 : RegulatoryStandard {
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-
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1"; }
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attribute :>> name = "IEC60601_1";
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attribute :>> designation = "IEC 60601-1:2005+AMD1:2012+AMD2:2020";
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attribute :>> edition = "3.2";
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attribute :>> issuer = "IEC";
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attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
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item iec60601_1Clause4 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1-4"; }
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attribute :>> name = "IEC60601_1Clause4";
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attribute :>> clauseNumber = "4";
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attribute :>> title = "general requirements for basic safety and essential performance";
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attribute :>> normativeStrength = "shall";
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item iec60601_1Clause4_2 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1-4-2"; }
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attribute :>> name = "IEC60601_1Clause4_2";
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attribute :>> clauseNumber = "4.2";
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attribute :>> title = "risk management process for medical electrical equipment";
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attribute :>> normativeStrength = "shall";
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}
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item iec60601_1Clause4_3 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1-4-3"; }
|
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42
|
+
attribute :>> name = "IEC60601_1Clause4_3";
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43
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+
attribute :>> clauseNumber = "4.3";
|
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44
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+
attribute :>> title = "essential performance identification";
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|
45
|
+
attribute :>> normativeStrength = "shall";
|
|
46
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+
}
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|
47
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+
}
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|
48
|
+
item iec60601_1Clause5 : StandardClause {
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49
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-5"; }
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50
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+
attribute :>> name = "IEC60601_1Clause5";
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51
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attribute :>> clauseNumber = "5";
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52
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attribute :>> title = "general requirements for testing";
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53
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attribute :>> normativeStrength = "shall";
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+
}
|
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55
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+
item iec60601_1Clause7 : StandardClause {
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56
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-7"; }
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57
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attribute :>> name = "IEC60601_1Clause7";
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attribute :>> clauseNumber = "7";
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attribute :>> title = "equipment identification, marking and accompanying documents";
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attribute :>> normativeStrength = "shall";
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}
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+
item iec60601_1Clause8 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-8"; }
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64
|
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attribute :>> name = "IEC60601_1Clause8";
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65
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attribute :>> clauseNumber = "8";
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attribute :>> title = "protection against electrical hazards";
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+
attribute :>> normativeStrength = "shall";
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+
}
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69
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+
item iec60601_1Clause9 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-9"; }
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attribute :>> name = "IEC60601_1Clause9";
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attribute :>> clauseNumber = "9";
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attribute :>> title = "protection against mechanical hazards";
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attribute :>> normativeStrength = "shall";
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+
}
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76
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+
item iec60601_1Clause10 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-10"; }
|
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78
|
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attribute :>> name = "IEC60601_1Clause10";
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79
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attribute :>> clauseNumber = "10";
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80
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attribute :>> title = "protection against unwanted and excessive radiation";
|
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+
attribute :>> normativeStrength = "shall";
|
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82
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+
}
|
|
83
|
+
item iec60601_1Clause11 : StandardClause {
|
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84
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-11"; }
|
|
85
|
+
attribute :>> name = "IEC60601_1Clause11";
|
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86
|
+
attribute :>> clauseNumber = "11";
|
|
87
|
+
attribute :>> title = "protection against excessive temperatures and related hazards";
|
|
88
|
+
attribute :>> normativeStrength = "shall";
|
|
89
|
+
}
|
|
90
|
+
item iec60601_1Clause12 : StandardClause {
|
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91
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-12"; }
|
|
92
|
+
attribute :>> name = "IEC60601_1Clause12";
|
|
93
|
+
attribute :>> clauseNumber = "12";
|
|
94
|
+
attribute :>> title = "accuracy of controls and protection against hazardous output";
|
|
95
|
+
attribute :>> normativeStrength = "shall";
|
|
96
|
+
}
|
|
97
|
+
item iec60601_1Clause13 : StandardClause {
|
|
98
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-13"; }
|
|
99
|
+
attribute :>> name = "IEC60601_1Clause13";
|
|
100
|
+
attribute :>> clauseNumber = "13";
|
|
101
|
+
attribute :>> title = "hazardous situations and fault conditions";
|
|
102
|
+
attribute :>> normativeStrength = "shall";
|
|
103
|
+
}
|
|
104
|
+
item iec60601_1Clause14 : StandardClause {
|
|
105
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-14"; }
|
|
106
|
+
attribute :>> name = "IEC60601_1Clause14";
|
|
107
|
+
attribute :>> clauseNumber = "14";
|
|
108
|
+
attribute :>> title = "programmable electrical medical systems";
|
|
109
|
+
attribute :>> normativeStrength = "shall";
|
|
110
|
+
}
|
|
111
|
+
item iec60601_1Clause15 : StandardClause {
|
|
112
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-15"; }
|
|
113
|
+
attribute :>> name = "IEC60601_1Clause15";
|
|
114
|
+
attribute :>> clauseNumber = "15";
|
|
115
|
+
attribute :>> title = "construction of medical electrical equipment";
|
|
116
|
+
attribute :>> normativeStrength = "shall";
|
|
117
|
+
}
|
|
118
|
+
item iec60601_1Clause16 : StandardClause {
|
|
119
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-16"; }
|
|
120
|
+
attribute :>> name = "IEC60601_1Clause16";
|
|
121
|
+
attribute :>> clauseNumber = "16";
|
|
122
|
+
attribute :>> title = "medical electrical systems";
|
|
123
|
+
attribute :>> normativeStrength = "shall";
|
|
124
|
+
}
|
|
125
|
+
item iec60601_1Clause17 : StandardClause {
|
|
126
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-17"; }
|
|
127
|
+
attribute :>> name = "IEC60601_1Clause17";
|
|
128
|
+
attribute :>> clauseNumber = "17";
|
|
129
|
+
attribute :>> title = "electromagnetic compatibility";
|
|
130
|
+
attribute :>> normativeStrength = "shall";
|
|
131
|
+
}
|
|
25
132
|
}
|
|
26
133
|
|
|
27
|
-
item iec60601_1Clause4 : StandardClause {
|
|
28
|
-
attribute :>> id = "STD-IEC-60601-1-4";
|
|
29
|
-
attribute :>> name = "IEC60601_1Clause4";
|
|
30
|
-
attribute :>> clauseNumber = "4";
|
|
31
|
-
attribute :>> title = "general requirements for basic safety and essential performance";
|
|
32
|
-
attribute :>> normativeStrength = "shall";
|
|
33
|
-
}
|
|
34
|
-
item iec60601_1Clause4_2 : StandardClause {
|
|
35
|
-
attribute :>> id = "STD-IEC-60601-1-4-2";
|
|
36
|
-
attribute :>> name = "IEC60601_1Clause4_2";
|
|
37
|
-
attribute :>> clauseNumber = "4.2";
|
|
38
|
-
attribute :>> title = "risk management process for medical electrical equipment";
|
|
39
|
-
attribute :>> normativeStrength = "shall";
|
|
40
|
-
}
|
|
41
|
-
item iec60601_1Clause4_3 : StandardClause {
|
|
42
|
-
attribute :>> id = "STD-IEC-60601-1-4-3";
|
|
43
|
-
attribute :>> name = "IEC60601_1Clause4_3";
|
|
44
|
-
attribute :>> clauseNumber = "4.3";
|
|
45
|
-
attribute :>> title = "essential performance identification";
|
|
46
|
-
attribute :>> normativeStrength = "shall";
|
|
47
|
-
}
|
|
48
|
-
item iec60601_1Clause5 : StandardClause {
|
|
49
|
-
attribute :>> id = "STD-IEC-60601-1-5";
|
|
50
|
-
attribute :>> name = "IEC60601_1Clause5";
|
|
51
|
-
attribute :>> clauseNumber = "5";
|
|
52
|
-
attribute :>> title = "general requirements for testing";
|
|
53
|
-
attribute :>> normativeStrength = "shall";
|
|
54
|
-
}
|
|
55
|
-
item iec60601_1Clause7 : StandardClause {
|
|
56
|
-
attribute :>> id = "STD-IEC-60601-1-7";
|
|
57
|
-
attribute :>> name = "IEC60601_1Clause7";
|
|
58
|
-
attribute :>> clauseNumber = "7";
|
|
59
|
-
attribute :>> title = "equipment identification, marking and accompanying documents";
|
|
60
|
-
attribute :>> normativeStrength = "shall";
|
|
61
|
-
}
|
|
62
|
-
item iec60601_1Clause8 : StandardClause {
|
|
63
|
-
attribute :>> id = "STD-IEC-60601-1-8";
|
|
64
|
-
attribute :>> name = "IEC60601_1Clause8";
|
|
65
|
-
attribute :>> clauseNumber = "8";
|
|
66
|
-
attribute :>> title = "protection against electrical hazards";
|
|
67
|
-
attribute :>> normativeStrength = "shall";
|
|
68
|
-
}
|
|
69
|
-
item iec60601_1Clause9 : StandardClause {
|
|
70
|
-
attribute :>> id = "STD-IEC-60601-1-9";
|
|
71
|
-
attribute :>> name = "IEC60601_1Clause9";
|
|
72
|
-
attribute :>> clauseNumber = "9";
|
|
73
|
-
attribute :>> title = "protection against mechanical hazards";
|
|
74
|
-
attribute :>> normativeStrength = "shall";
|
|
75
|
-
}
|
|
76
|
-
item iec60601_1Clause10 : StandardClause {
|
|
77
|
-
attribute :>> id = "STD-IEC-60601-1-10";
|
|
78
|
-
attribute :>> name = "IEC60601_1Clause10";
|
|
79
|
-
attribute :>> clauseNumber = "10";
|
|
80
|
-
attribute :>> title = "protection against unwanted and excessive radiation";
|
|
81
|
-
attribute :>> normativeStrength = "shall";
|
|
82
|
-
}
|
|
83
|
-
item iec60601_1Clause11 : StandardClause {
|
|
84
|
-
attribute :>> id = "STD-IEC-60601-1-11";
|
|
85
|
-
attribute :>> name = "IEC60601_1Clause11";
|
|
86
|
-
attribute :>> clauseNumber = "11";
|
|
87
|
-
attribute :>> title = "protection against excessive temperatures and related hazards";
|
|
88
|
-
attribute :>> normativeStrength = "shall";
|
|
89
|
-
}
|
|
90
|
-
item iec60601_1Clause12 : StandardClause {
|
|
91
|
-
attribute :>> id = "STD-IEC-60601-1-12";
|
|
92
|
-
attribute :>> name = "IEC60601_1Clause12";
|
|
93
|
-
attribute :>> clauseNumber = "12";
|
|
94
|
-
attribute :>> title = "accuracy of controls and protection against hazardous output";
|
|
95
|
-
attribute :>> normativeStrength = "shall";
|
|
96
|
-
}
|
|
97
|
-
item iec60601_1Clause13 : StandardClause {
|
|
98
|
-
attribute :>> id = "STD-IEC-60601-1-13";
|
|
99
|
-
attribute :>> name = "IEC60601_1Clause13";
|
|
100
|
-
attribute :>> clauseNumber = "13";
|
|
101
|
-
attribute :>> title = "hazardous situations and fault conditions";
|
|
102
|
-
attribute :>> normativeStrength = "shall";
|
|
103
|
-
}
|
|
104
|
-
item iec60601_1Clause14 : StandardClause {
|
|
105
|
-
attribute :>> id = "STD-IEC-60601-1-14";
|
|
106
|
-
attribute :>> name = "IEC60601_1Clause14";
|
|
107
|
-
attribute :>> clauseNumber = "14";
|
|
108
|
-
attribute :>> title = "programmable electrical medical systems";
|
|
109
|
-
attribute :>> normativeStrength = "shall";
|
|
110
|
-
}
|
|
111
|
-
item iec60601_1Clause15 : StandardClause {
|
|
112
|
-
attribute :>> id = "STD-IEC-60601-1-15";
|
|
113
|
-
attribute :>> name = "IEC60601_1Clause15";
|
|
114
|
-
attribute :>> clauseNumber = "15";
|
|
115
|
-
attribute :>> title = "construction of medical electrical equipment";
|
|
116
|
-
attribute :>> normativeStrength = "shall";
|
|
117
|
-
}
|
|
118
|
-
item iec60601_1Clause16 : StandardClause {
|
|
119
|
-
attribute :>> id = "STD-IEC-60601-1-16";
|
|
120
|
-
attribute :>> name = "IEC60601_1Clause16";
|
|
121
|
-
attribute :>> clauseNumber = "16";
|
|
122
|
-
attribute :>> title = "medical electrical systems";
|
|
123
|
-
attribute :>> normativeStrength = "shall";
|
|
124
|
-
}
|
|
125
|
-
item iec60601_1Clause17 : StandardClause {
|
|
126
|
-
attribute :>> id = "STD-IEC-60601-1-17";
|
|
127
|
-
attribute :>> name = "IEC60601_1Clause17";
|
|
128
|
-
attribute :>> clauseNumber = "17";
|
|
129
|
-
attribute :>> title = "electromagnetic compatibility";
|
|
130
|
-
attribute :>> normativeStrength = "shall";
|
|
131
|
-
}
|
|
132
134
|
|
|
133
|
-
connection iec60601_1Has4 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause4;
|
|
134
|
-
connection iec60601_1Has5 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause5;
|
|
135
|
-
connection iec60601_1Has7 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause7;
|
|
136
|
-
connection iec60601_1Has8 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause8;
|
|
137
|
-
connection iec60601_1Has9 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause9;
|
|
138
|
-
connection iec60601_1Has10 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause10;
|
|
139
|
-
connection iec60601_1Has11 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause11;
|
|
140
|
-
connection iec60601_1Has12 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause12;
|
|
141
|
-
connection iec60601_1Has13 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause13;
|
|
142
|
-
connection iec60601_1Has14 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause14;
|
|
143
|
-
connection iec60601_1Has15 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause15;
|
|
144
|
-
connection iec60601_1Has16 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause16;
|
|
145
|
-
connection iec60601_1Has17 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause17;
|
|
146
135
|
|
|
147
|
-
connection iec60601_1Has4_2 : Composes connect parent ::> iec60601_1Clause4 to child ::> iec60601_1Clause4_2;
|
|
148
|
-
connection iec60601_1Has4_3 : Composes connect parent ::> iec60601_1Clause4 to child ::> iec60601_1Clause4_3;
|
|
149
136
|
}
|
|
@@ -10,47 +10,45 @@ package memo_artifacts_standards_iec_60601_1_2 {
|
|
|
10
10
|
private import memo_core_relationships::*;
|
|
11
11
|
private import memo_artifacts_standards_traceability::*;
|
|
12
12
|
|
|
13
|
+
private import memo_core_common::*;
|
|
14
|
+
private import memo_core_common::MemoIdentity;
|
|
13
15
|
item iec60601_1_2 : RegulatoryStandard {
|
|
14
|
-
|
|
16
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-2-COLLATERAL"; }
|
|
15
17
|
attribute :>> name = "IEC60601_1_2";
|
|
16
18
|
attribute :>> designation = "IEC 60601-1-2:2014+AMD1:2020";
|
|
17
19
|
attribute :>> edition = "4.1";
|
|
18
20
|
attribute :>> issuer = "IEC";
|
|
19
21
|
attribute :>> amendments = "AMD1:2020";
|
|
20
22
|
attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
|
|
23
|
+
item iec60601_1_2Clause4 : StandardClause {
|
|
24
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-2-4"; }
|
|
25
|
+
attribute :>> name = "IEC60601_1_2Clause4";
|
|
26
|
+
attribute :>> clauseNumber = "4";
|
|
27
|
+
attribute :>> title = "general requirements for electromagnetic disturbances";
|
|
28
|
+
attribute :>> normativeStrength = "shall";
|
|
29
|
+
}
|
|
30
|
+
item iec60601_1_2Clause5 : StandardClause {
|
|
31
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-2-5"; }
|
|
32
|
+
attribute :>> name = "IEC60601_1_2Clause5";
|
|
33
|
+
attribute :>> clauseNumber = "5";
|
|
34
|
+
attribute :>> title = "electromagnetic compatibility information in accompanying documents";
|
|
35
|
+
attribute :>> normativeStrength = "shall";
|
|
36
|
+
}
|
|
37
|
+
item iec60601_1_2Clause7 : StandardClause {
|
|
38
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-2-7"; }
|
|
39
|
+
attribute :>> name = "IEC60601_1_2Clause7";
|
|
40
|
+
attribute :>> clauseNumber = "7";
|
|
41
|
+
attribute :>> title = "electromagnetic emissions";
|
|
42
|
+
attribute :>> normativeStrength = "shall";
|
|
43
|
+
}
|
|
44
|
+
item iec60601_1_2Clause8 : StandardClause {
|
|
45
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-2-8"; }
|
|
46
|
+
attribute :>> name = "IEC60601_1_2Clause8";
|
|
47
|
+
attribute :>> clauseNumber = "8";
|
|
48
|
+
attribute :>> title = "electromagnetic immunity";
|
|
49
|
+
attribute :>> normativeStrength = "shall";
|
|
50
|
+
}
|
|
21
51
|
}
|
|
22
52
|
|
|
23
|
-
item iec60601_1_2Clause4 : StandardClause {
|
|
24
|
-
attribute :>> id = "STD-IEC-60601-1-2-4";
|
|
25
|
-
attribute :>> name = "IEC60601_1_2Clause4";
|
|
26
|
-
attribute :>> clauseNumber = "4";
|
|
27
|
-
attribute :>> title = "general requirements for electromagnetic disturbances";
|
|
28
|
-
attribute :>> normativeStrength = "shall";
|
|
29
|
-
}
|
|
30
|
-
item iec60601_1_2Clause5 : StandardClause {
|
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31
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attribute :>> id = "STD-IEC-60601-1-2-5";
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32
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attribute :>> name = "IEC60601_1_2Clause5";
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33
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attribute :>> clauseNumber = "5";
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attribute :>> title = "electromagnetic compatibility information in accompanying documents";
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35
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attribute :>> normativeStrength = "shall";
|
|
36
|
-
}
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37
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-
item iec60601_1_2Clause7 : StandardClause {
|
|
38
|
-
attribute :>> id = "STD-IEC-60601-1-2-7";
|
|
39
|
-
attribute :>> name = "IEC60601_1_2Clause7";
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|
40
|
-
attribute :>> clauseNumber = "7";
|
|
41
|
-
attribute :>> title = "electromagnetic emissions";
|
|
42
|
-
attribute :>> normativeStrength = "shall";
|
|
43
|
-
}
|
|
44
|
-
item iec60601_1_2Clause8 : StandardClause {
|
|
45
|
-
attribute :>> id = "STD-IEC-60601-1-2-8";
|
|
46
|
-
attribute :>> name = "IEC60601_1_2Clause8";
|
|
47
|
-
attribute :>> clauseNumber = "8";
|
|
48
|
-
attribute :>> title = "electromagnetic immunity";
|
|
49
|
-
attribute :>> normativeStrength = "shall";
|
|
50
|
-
}
|
|
51
53
|
|
|
52
|
-
connection iec60601_1_2Has4 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause4;
|
|
53
|
-
connection iec60601_1_2Has5 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause5;
|
|
54
|
-
connection iec60601_1_2Has7 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause7;
|
|
55
|
-
connection iec60601_1_2Has8 : Composes connect parent ::> iec60601_1_2 to child ::> iec60601_1_2Clause8;
|
|
56
54
|
}
|
|
@@ -14,8 +14,10 @@ package memo_artifacts_standards_iec_60812 {
|
|
|
14
14
|
private import memo_core_relationships::*;
|
|
15
15
|
private import memo_artifacts_standards_traceability::*;
|
|
16
16
|
|
|
17
|
+
private import memo_core_common::*;
|
|
18
|
+
private import memo_core_common::MemoIdentity;
|
|
17
19
|
item iec60812 : RegulatoryStandard {
|
|
18
|
-
|
|
20
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60812"; }
|
|
19
21
|
attribute :>> name = "IEC60812";
|
|
20
22
|
attribute :>> designation = "IEC 60812:2018";
|
|
21
23
|
attribute :>> edition = "2018";
|
|
@@ -24,28 +26,25 @@ package memo_artifacts_standards_iec_60812 {
|
|
|
24
26
|
// reference standard, cited by documents rather than required by a
|
|
25
27
|
// market. Empty is the authored value, not an omission — see
|
|
26
28
|
// appliesToRegime in memo_artifacts_standards_traceability.
|
|
29
|
+
item iec60812Clause5 : StandardClause {
|
|
30
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60812-5"; }
|
|
31
|
+
attribute :>> name = "IEC60812Clause5";
|
|
32
|
+
attribute :>> clauseNumber = "5";
|
|
33
|
+
attribute :>> normativeStrength = "shall";
|
|
34
|
+
}
|
|
35
|
+
item iec60812Clause6 : StandardClause {
|
|
36
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60812-6"; }
|
|
37
|
+
attribute :>> name = "IEC60812Clause6";
|
|
38
|
+
attribute :>> clauseNumber = "6";
|
|
39
|
+
attribute :>> normativeStrength = "shall";
|
|
40
|
+
}
|
|
41
|
+
item iec60812Clause7 : StandardClause {
|
|
42
|
+
@MemoIdentity { :>> providedId = "STD-IEC-60812-7"; }
|
|
43
|
+
attribute :>> name = "IEC60812Clause7";
|
|
44
|
+
attribute :>> clauseNumber = "7";
|
|
45
|
+
attribute :>> normativeStrength = "shall";
|
|
46
|
+
}
|
|
27
47
|
}
|
|
28
48
|
|
|
29
|
-
item iec60812Clause5 : StandardClause {
|
|
30
|
-
attribute :>> id = "STD-IEC-60812-5";
|
|
31
|
-
attribute :>> name = "IEC60812Clause5";
|
|
32
|
-
attribute :>> clauseNumber = "5";
|
|
33
|
-
attribute :>> normativeStrength = "shall";
|
|
34
|
-
}
|
|
35
|
-
item iec60812Clause6 : StandardClause {
|
|
36
|
-
attribute :>> id = "STD-IEC-60812-6";
|
|
37
|
-
attribute :>> name = "IEC60812Clause6";
|
|
38
|
-
attribute :>> clauseNumber = "6";
|
|
39
|
-
attribute :>> normativeStrength = "shall";
|
|
40
|
-
}
|
|
41
|
-
item iec60812Clause7 : StandardClause {
|
|
42
|
-
attribute :>> id = "STD-IEC-60812-7";
|
|
43
|
-
attribute :>> name = "IEC60812Clause7";
|
|
44
|
-
attribute :>> clauseNumber = "7";
|
|
45
|
-
attribute :>> normativeStrength = "shall";
|
|
46
|
-
}
|
|
47
49
|
|
|
48
|
-
connection iec60812Has5 : Composes connect parent ::> iec60812 to child ::> iec60812Clause5;
|
|
49
|
-
connection iec60812Has6 : Composes connect parent ::> iec60812 to child ::> iec60812Clause6;
|
|
50
|
-
connection iec60812Has7 : Composes connect parent ::> iec60812 to child ::> iec60812Clause7;
|
|
51
50
|
}
|