@memoarchitect/ontology 0.8.24 → 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/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/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +9 -7
- package/examples/embedded-infusion-pump/model/catalog/project.sysml +3 -1
- package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +8 -6
- package/examples/functional-logical-physical/model/catalog/project.sysml +3 -1
- package/examples/gpca-pump/memo.identity.yaml +2179 -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 +22 -20
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +14 -13
- 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 +121 -125
- 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 +15 -14
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +10 -8
- 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 +6 -4
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/cybersecurity_cybersecurity_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_cyber_assessment_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_threat_model_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_allocation_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_browser_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/behavior_action_flow_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/document_architecture_description_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_device_interconnect_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_logical_architecture_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_mode_state_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_system_decomposition_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_scenario_sequence_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_use_case_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/physical/views/physical_physical_bom_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/document_dhf_index_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/requirements_requirements_trace_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_hazard_analysis_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_rmf_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_fmea_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_risk_chain_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/software/views/document_sdd_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/software/views/software_software_architecture_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/usability/views/document_usability_view.sysml +6 -4
- package/examples/gpca-pump/model/catalog/viewpoints/verification/views/document_vv_view.sysml +5 -3
- package/examples/gpca-pump/model/catalog/viewpoints/verification/views/verification_verification_coverage_view.sysml +5 -3
- package/examples/ivd-laboratory-system/model/catalog/ivd_laboratory_system.sysml +9 -7
- package/examples/ivd-laboratory-system/model/catalog/project.sysml +3 -1
- package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +6 -4
- package/examples/manual-surgical-instrument/model/catalog/project.sysml +3 -1
- package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -4
- package/examples/multidimensional-layers/model/catalog/project.sysml +3 -1
- 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/model/catalog/project.sysml +3 -1
- package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +17 -16
- 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/software-only-medical-device/model/catalog/project.sysml +3 -1
- package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +10 -8
- package/examples/surgical-closure-workflow/model/catalog/project.sysml +3 -1
- package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +51 -51
- package/examples/surgical-robot/model/catalog/project.sysml +3 -1
- package/examples/surgical-robot/model/catalog/surgical_robot.sysml +9 -7
- 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 +10 -8
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.sysml +7 -5
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +3 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +2 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +3 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/requirements_view.sysml +8 -6
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +3 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +2 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +3 -1
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/use_case_view.sysml +11 -7
- package/examples/temperature-alarm/memo.identity.yaml +64 -0
- package/examples/temperature-alarm/model/catalog/project.sysml +3 -1
- package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +27 -22
- 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 +5 -3
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +5 -3
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +5 -3
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +3 -1
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +3 -1
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +3 -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/src/methodology/cloud_methodology.sysml +3 -1
- package/extensions/container/src/methodology/container_methodology.sysml +3 -1
- package/extensions/messaging/src/methodology/messaging_methodology.sysml +3 -1
- package/extensions/ros/src/methodology/ros_methodology.sysml +3 -1
- package/extensions/template/src/extension.sysml +3 -1
- package/package.json +2 -2
- package/src/architecture/functional/behavior/memo_behavior.sysml +1 -1
- 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/ui/memo_ui.sysml +0 -23
- package/src/architecture/logical/interfaces/memo_interfaces.sysml +3 -1
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +3 -11
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +0 -10
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +7 -11
- package/src/architecture/operational/workflows/memo_workflows.sysml +0 -20
- package/src/architecture/realization/deployment/memo_deployment.sysml +16 -9
- 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/assurance/verification_validation/memo_assurance.sysml +7 -12
- package/src/core/common/memo_common.sysml +50 -50
- package/src/core/enumerations/memo_enumerations.sysml +1 -1
- package/src/core/relationships/memo_relationships.sysml +22 -49
- 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/rules/closure/closure_rules.sysml +22 -20
- package/src/rules/crosslayer/cross_layer_rules.sysml +4 -2
- package/src/rules/ontology/ontology_invariants.sysml +106 -33
- package/src/rules/quantitative/quantitative_rules.sysml +4 -2
- package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +29 -28
- package/src/viewpoints/clinical/clinical_viewpoint.sysml +4 -2
- package/src/viewpoints/context/context_viewpoint.sysml +5 -3
- package/src/viewpoints/context/views/system_context_view/system_context_view.sysml +5 -3
- package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +4 -2
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +6 -16
- package/src/viewpoints/functional/functional_viewpoint.sysml +4 -2
- package/src/viewpoints/functional/views/function_allocation_view/function_allocation_view.sysml +5 -3
- package/src/viewpoints/functional/views/system_functional_tree_view/system_functional_tree_view.sysml +5 -3
- package/src/viewpoints/logical/logical_viewpoint.sysml +4 -2
- package/src/viewpoints/logical/views/logical_architecture_view/logical_architecture_view.sysml +5 -3
- package/src/viewpoints/operational/operational_viewpoint.sysml +4 -2
- package/src/viewpoints/operational/views/use_case_view/use_case_view.sysml +5 -3
- package/src/viewpoints/physical/physical_viewpoint.sysml +4 -2
- package/src/viewpoints/physical/views/network_topology_view/network_topology_view.sysml +5 -3
- package/src/viewpoints/physical/views/physical_bom_view/physical_bom_view.sysml +5 -3
- package/src/viewpoints/rendering/memo_rendering.sysml +220 -40
- package/src/viewpoints/requirements/requirements_viewpoint.sysml +4 -2
- package/src/viewpoints/requirements/views/requirements_traceability_view/requirements_traceability_view.sysml +5 -3
- package/src/viewpoints/risk/risk_viewpoint.sysml +4 -2
- package/src/viewpoints/risk/views/risk_chain_view/risk_chain_view.sysml +5 -3
- package/src/viewpoints/software/software_viewpoint.sysml +4 -2
- package/src/viewpoints/software/views/software_architecture_view/software_architecture_view.sysml +5 -3
- package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +4 -2
- package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +3 -1
- package/src/viewpoints/usability/usability_viewpoint.sysml +4 -2
- package/src/viewpoints/verification/verification_viewpoint.sysml +4 -2
- package/src/viewpoints/verification/views/verification_coverage_view/verification_coverage_view.sysml +5 -3
- package/templates/connected-device/model/catalog/project.sysml +3 -1
- package/templates/default/model/catalog/project.sysml +3 -1
- package/templates/infusion-pump/model/catalog/project.sysml +3 -1
- package/templates/monitoring-device/model/catalog/project.sysml +3 -1
- package/templates/samd/model/catalog/project.sysml +3 -1
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@@ -91,26 +91,6 @@ package memo_architecture_operational_workflows {
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// SupportKind discriminator is gone: what used to be three enum values
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// that each implied a different target type are now two typed refs plus
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// this one plain relation.
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connection def Supports :> MemoRelationship {
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end supporter :>> source;
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end supported : MemoAction :>> target;
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}
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abstract connection supportsLinks : Supports[*];
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metadata def <supports> SupportsMetadata :> SemanticMetadata {
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:> annotatedElement : SysML::ConnectionDefinition;
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:> annotatedElement : SysML::ConnectionUsage;
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:>> baseType = supportsLinks meta SysML::Usage;
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}
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connection def RequiresResource :> MemoRelationship {
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end workflow : OperationalWorkflow :>> source;
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end resource : WorkflowResource :>> target;
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}
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abstract connection requiresResourceLinks : RequiresResource[*];
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metadata def <requiresResource> RequiresResourceMetadata :> SemanticMetadata {
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:>> baseType = requiresResourceLinks meta SysML::Usage;
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}
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// ── Workflow transformation (as-is → to-be) ──────────────────
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// Transforms unifies TransformsStep / TransformsWorkflow / ReplacesWorkflow
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attribute certificationEvidence : String;
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}
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// language has one. Rooted like MemoryBinding / ConnectionBinding below,
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end module : SoftwareModule :>> source;
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end deploymentUnit : SoftwareDeploymentUnit :>> target;
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}
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abstract connection buildsIntoLinks : BuildsInto[*];
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metadata def <buildsInto> BuildsIntoMetadata :> SemanticMetadata {
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:> annotatedElement : SysML::
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:>> baseType = buildsIntoLinks meta SysML::Usage;
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}
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end node : ProcessingNode :>> target;
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abstract connection deploysToLinks : DeploysTo[*];
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connection def ProvidesEnvironment :> MemoRelationship {
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:>> baseType = flowComprisesSpecLinks meta SysML::Usage;
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}
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// The flow traverses a software→hardware binding; latency accrues here.
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end endToEndFlow : EndToEndFlow :>> source;
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end deploymentUnit : SoftwareDeploymentUnit :>> target;
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}
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abstract connection flowTraversesBindingLinks : FlowTraversesBinding[*];
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metadata def <flowTraversesBinding> FlowTraversesBindingMetadata :> SemanticMetadata {
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:>> baseType = flowTraversesBindingLinks meta SysML::Usage;
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}
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private import memo_core_common::*;
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private import memo_core_enumerations::*;
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// For PhysicalElement: a processing node and a memory device ARE physical
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// things — a board and a chip — and specialized MemoPart directly only
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// because the physical family had no shared root until CR-ONT-079 needed
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// one. Their home package reflects their ROLE (deployment target), not
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// their nature.
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private import memo_architecture_implementation_hardware_common::PhysicalElement;
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part def ProcessingNode specializes PhysicalElement {
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attribute nodeKind : ProcessingNodeKind;
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attribute processorArchitecture : String;
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attribute memoryMB : String;
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@@ -17,7 +23,7 @@ package memo_architecture_realization_physical {
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attribute supportsContainerization : Boolean;
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attribute realTimeCapable : Boolean;
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}
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-
part def MemoryDevice specializes
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part def MemoryDevice specializes PhysicalElement {
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attribute memoryKind : String;
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attribute capacityMB : String;
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attribute nonVolatile : Boolean;
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@@ -15,102 +15,93 @@ package memo_artifacts_standards_cfr_21_820 {
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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 cfr21Part820 : RegulatoryStandard {
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-
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+
@MemoIdentity { :>> providedId = "STD-21-CFR-820"; }
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attribute :>> name = "CFR21Part820";
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attribute :>> designation = "21 CFR Part 820";
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attribute :>> issuer = "FDA";
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attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
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+
item cfr820_30 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-21-CFR-820-30"; }
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attribute :>> name = "CFR820_30";
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attribute :>> clauseNumber = "820.30";
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attribute :>> title = "design controls";
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attribute :>> normativeStrength = "shall";
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item cfr820_30a : StandardClause {
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@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-A"; }
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attribute :>> name = "CFR820_30a";
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attribute :>> clauseNumber = "820.30(a)";
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attribute :>> title = "general design control applicability";
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attribute :>> normativeStrength = "shall";
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}
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+
item cfr820_30b : StandardClause {
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@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-B"; }
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attribute :>> name = "CFR820_30b";
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attribute :>> clauseNumber = "820.30(b)";
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attribute :>> title = "design and development planning";
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attribute :>> normativeStrength = "shall";
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+
}
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+
item cfr820_30c : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-C"; }
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+
attribute :>> name = "CFR820_30c";
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attribute :>> clauseNumber = "820.30(c)";
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attribute :>> title = "design input";
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attribute :>> normativeStrength = "shall";
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}
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+
item cfr820_30d : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-D"; }
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attribute :>> name = "CFR820_30d";
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attribute :>> clauseNumber = "820.30(d)";
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attribute :>> title = "design output";
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attribute :>> normativeStrength = "shall";
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+
}
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+
item cfr820_30e : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-E"; }
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attribute :>> name = "CFR820_30e";
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attribute :>> clauseNumber = "820.30(e)";
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attribute :>> title = "design review";
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65
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+
attribute :>> normativeStrength = "shall";
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66
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+
}
|
|
67
|
+
item cfr820_30f : StandardClause {
|
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68
|
+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-F"; }
|
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|
+
attribute :>> name = "CFR820_30f";
|
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+
attribute :>> clauseNumber = "820.30(f)";
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+
attribute :>> title = "design verification";
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+
attribute :>> normativeStrength = "shall";
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+
}
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74
|
+
item cfr820_30g : StandardClause {
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75
|
+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-G"; }
|
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|
+
attribute :>> name = "CFR820_30g";
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+
attribute :>> clauseNumber = "820.30(g)";
|
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|
+
attribute :>> title = "design validation";
|
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|
+
attribute :>> normativeStrength = "shall";
|
|
80
|
+
}
|
|
81
|
+
item cfr820_30h : StandardClause {
|
|
82
|
+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-H"; }
|
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|
+
attribute :>> name = "CFR820_30h";
|
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84
|
+
attribute :>> clauseNumber = "820.30(h)";
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85
|
+
attribute :>> title = "design transfer";
|
|
86
|
+
attribute :>> normativeStrength = "shall";
|
|
87
|
+
}
|
|
88
|
+
item cfr820_30i : StandardClause {
|
|
89
|
+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-I"; }
|
|
90
|
+
attribute :>> name = "CFR820_30i";
|
|
91
|
+
attribute :>> clauseNumber = "820.30(i)";
|
|
92
|
+
attribute :>> title = "design changes";
|
|
93
|
+
attribute :>> normativeStrength = "shall";
|
|
94
|
+
}
|
|
95
|
+
item cfr820_30j : StandardClause {
|
|
96
|
+
@MemoIdentity { :>> providedId = "STD-21-CFR-820-30-J"; }
|
|
97
|
+
attribute :>> name = "CFR820_30j";
|
|
98
|
+
attribute :>> clauseNumber = "820.30(j)";
|
|
99
|
+
attribute :>> title = "design history file";
|
|
100
|
+
attribute :>> normativeStrength = "shall";
|
|
101
|
+
}
|
|
102
|
+
}
|
|
24
103
|
}
|
|
25
104
|
|
|
26
|
-
item cfr820_30 : StandardClause {
|
|
27
|
-
attribute :>> id = "STD-21-CFR-820-30";
|
|
28
|
-
attribute :>> name = "CFR820_30";
|
|
29
|
-
attribute :>> clauseNumber = "820.30";
|
|
30
|
-
attribute :>> title = "design controls";
|
|
31
|
-
attribute :>> normativeStrength = "shall";
|
|
32
|
-
}
|
|
33
|
-
item cfr820_30a : StandardClause {
|
|
34
|
-
attribute :>> id = "STD-21-CFR-820-30-A";
|
|
35
|
-
attribute :>> name = "CFR820_30a";
|
|
36
|
-
attribute :>> clauseNumber = "820.30(a)";
|
|
37
|
-
attribute :>> title = "general design control applicability";
|
|
38
|
-
attribute :>> normativeStrength = "shall";
|
|
39
|
-
}
|
|
40
|
-
item cfr820_30b : StandardClause {
|
|
41
|
-
attribute :>> id = "STD-21-CFR-820-30-B";
|
|
42
|
-
attribute :>> name = "CFR820_30b";
|
|
43
|
-
attribute :>> clauseNumber = "820.30(b)";
|
|
44
|
-
attribute :>> title = "design and development planning";
|
|
45
|
-
attribute :>> normativeStrength = "shall";
|
|
46
|
-
}
|
|
47
|
-
item cfr820_30c : StandardClause {
|
|
48
|
-
attribute :>> id = "STD-21-CFR-820-30-C";
|
|
49
|
-
attribute :>> name = "CFR820_30c";
|
|
50
|
-
attribute :>> clauseNumber = "820.30(c)";
|
|
51
|
-
attribute :>> title = "design input";
|
|
52
|
-
attribute :>> normativeStrength = "shall";
|
|
53
|
-
}
|
|
54
|
-
item cfr820_30d : StandardClause {
|
|
55
|
-
attribute :>> id = "STD-21-CFR-820-30-D";
|
|
56
|
-
attribute :>> name = "CFR820_30d";
|
|
57
|
-
attribute :>> clauseNumber = "820.30(d)";
|
|
58
|
-
attribute :>> title = "design output";
|
|
59
|
-
attribute :>> normativeStrength = "shall";
|
|
60
|
-
}
|
|
61
|
-
item cfr820_30e : StandardClause {
|
|
62
|
-
attribute :>> id = "STD-21-CFR-820-30-E";
|
|
63
|
-
attribute :>> name = "CFR820_30e";
|
|
64
|
-
attribute :>> clauseNumber = "820.30(e)";
|
|
65
|
-
attribute :>> title = "design review";
|
|
66
|
-
attribute :>> normativeStrength = "shall";
|
|
67
|
-
}
|
|
68
|
-
item cfr820_30f : StandardClause {
|
|
69
|
-
attribute :>> id = "STD-21-CFR-820-30-F";
|
|
70
|
-
attribute :>> name = "CFR820_30f";
|
|
71
|
-
attribute :>> clauseNumber = "820.30(f)";
|
|
72
|
-
attribute :>> title = "design verification";
|
|
73
|
-
attribute :>> normativeStrength = "shall";
|
|
74
|
-
}
|
|
75
|
-
item cfr820_30g : StandardClause {
|
|
76
|
-
attribute :>> id = "STD-21-CFR-820-30-G";
|
|
77
|
-
attribute :>> name = "CFR820_30g";
|
|
78
|
-
attribute :>> clauseNumber = "820.30(g)";
|
|
79
|
-
attribute :>> title = "design validation";
|
|
80
|
-
attribute :>> normativeStrength = "shall";
|
|
81
|
-
}
|
|
82
|
-
item cfr820_30h : StandardClause {
|
|
83
|
-
attribute :>> id = "STD-21-CFR-820-30-H";
|
|
84
|
-
attribute :>> name = "CFR820_30h";
|
|
85
|
-
attribute :>> clauseNumber = "820.30(h)";
|
|
86
|
-
attribute :>> title = "design transfer";
|
|
87
|
-
attribute :>> normativeStrength = "shall";
|
|
88
|
-
}
|
|
89
|
-
item cfr820_30i : StandardClause {
|
|
90
|
-
attribute :>> id = "STD-21-CFR-820-30-I";
|
|
91
|
-
attribute :>> name = "CFR820_30i";
|
|
92
|
-
attribute :>> clauseNumber = "820.30(i)";
|
|
93
|
-
attribute :>> title = "design changes";
|
|
94
|
-
attribute :>> normativeStrength = "shall";
|
|
95
|
-
}
|
|
96
|
-
item cfr820_30j : StandardClause {
|
|
97
|
-
attribute :>> id = "STD-21-CFR-820-30-J";
|
|
98
|
-
attribute :>> name = "CFR820_30j";
|
|
99
|
-
attribute :>> clauseNumber = "820.30(j)";
|
|
100
|
-
attribute :>> title = "design history file";
|
|
101
|
-
attribute :>> normativeStrength = "shall";
|
|
102
|
-
}
|
|
103
105
|
|
|
104
|
-
connection cfr820Has30 : Composes connect parent ::> cfr21Part820 to child ::> cfr820_30;
|
|
105
106
|
|
|
106
|
-
connection cfr820_30HasA : Composes connect parent ::> cfr820_30 to child ::> cfr820_30a;
|
|
107
|
-
connection cfr820_30HasB : Composes connect parent ::> cfr820_30 to child ::> cfr820_30b;
|
|
108
|
-
connection cfr820_30HasC : Composes connect parent ::> cfr820_30 to child ::> cfr820_30c;
|
|
109
|
-
connection cfr820_30HasD : Composes connect parent ::> cfr820_30 to child ::> cfr820_30d;
|
|
110
|
-
connection cfr820_30HasE : Composes connect parent ::> cfr820_30 to child ::> cfr820_30e;
|
|
111
|
-
connection cfr820_30HasF : Composes connect parent ::> cfr820_30 to child ::> cfr820_30f;
|
|
112
|
-
connection cfr820_30HasG : Composes connect parent ::> cfr820_30 to child ::> cfr820_30g;
|
|
113
|
-
connection cfr820_30HasH : Composes connect parent ::> cfr820_30 to child ::> cfr820_30h;
|
|
114
|
-
connection cfr820_30HasI : Composes connect parent ::> cfr820_30 to child ::> cfr820_30i;
|
|
115
|
-
connection cfr820_30HasJ : Composes connect parent ::> cfr820_30 to child ::> cfr820_30j;
|
|
116
107
|
}
|
|
@@ -18,63 +18,59 @@ package memo_artifacts_standards_fda_cybersecurity_2023 {
|
|
|
18
18
|
private import memo_core_relationships::*;
|
|
19
19
|
private import memo_artifacts_standards_traceability::*;
|
|
20
20
|
|
|
21
|
+
private import memo_core_common::*;
|
|
22
|
+
private import memo_core_common::MemoIdentity;
|
|
21
23
|
item fdaCybersecurity2023 : RegulatoryStandard {
|
|
22
|
-
|
|
24
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023"; }
|
|
23
25
|
attribute :>> name = "FDACybersecurity2023";
|
|
24
26
|
attribute :>> designation = "FDA Cybersecurity Guidance 2023";
|
|
25
27
|
attribute :>> edition = "2023-09";
|
|
26
28
|
attribute :>> issuer = "FDA";
|
|
27
29
|
attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
|
|
30
|
+
item fdaCyberSection4 : StandardClause {
|
|
31
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-IV"; }
|
|
32
|
+
attribute :>> name = "FDACyberSectionIV";
|
|
33
|
+
attribute :>> clauseNumber = "IV";
|
|
34
|
+
attribute :>> title = "general cybersecurity principles";
|
|
35
|
+
attribute :>> normativeStrength = "informative";
|
|
36
|
+
}
|
|
37
|
+
item fdaCyberSection5 : StandardClause {
|
|
38
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-V"; }
|
|
39
|
+
attribute :>> name = "FDACyberSectionV";
|
|
40
|
+
attribute :>> clauseNumber = "V";
|
|
41
|
+
attribute :>> title = "secure product development framework";
|
|
42
|
+
attribute :>> normativeStrength = "informative";
|
|
43
|
+
item fdaCyberSection5A : StandardClause {
|
|
44
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-V-A"; }
|
|
45
|
+
attribute :>> name = "FDACyberSectionVA";
|
|
46
|
+
attribute :>> clauseNumber = "V.A";
|
|
47
|
+
attribute :>> title = "security risk management";
|
|
48
|
+
attribute :>> normativeStrength = "informative";
|
|
49
|
+
}
|
|
50
|
+
item fdaCyberSection5B : StandardClause {
|
|
51
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-V-B"; }
|
|
52
|
+
attribute :>> name = "FDACyberSectionVB";
|
|
53
|
+
attribute :>> clauseNumber = "V.B";
|
|
54
|
+
attribute :>> title = "security architecture";
|
|
55
|
+
attribute :>> normativeStrength = "informative";
|
|
56
|
+
}
|
|
57
|
+
item fdaCyberSection5C : StandardClause {
|
|
58
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-V-C"; }
|
|
59
|
+
attribute :>> name = "FDACyberSectionVC";
|
|
60
|
+
attribute :>> clauseNumber = "V.C";
|
|
61
|
+
attribute :>> title = "cybersecurity testing";
|
|
62
|
+
attribute :>> normativeStrength = "informative";
|
|
63
|
+
}
|
|
64
|
+
}
|
|
65
|
+
item fdaCyberSection6 : StandardClause {
|
|
66
|
+
@MemoIdentity { :>> providedId = "STD-FDA-CYBER-2023-VI"; }
|
|
67
|
+
attribute :>> name = "FDACyberSectionVI";
|
|
68
|
+
attribute :>> clauseNumber = "VI";
|
|
69
|
+
attribute :>> title = "cybersecurity transparency and vulnerability management";
|
|
70
|
+
attribute :>> normativeStrength = "informative";
|
|
71
|
+
}
|
|
28
72
|
}
|
|
29
73
|
|
|
30
|
-
item fdaCyberSection4 : StandardClause {
|
|
31
|
-
attribute :>> id = "STD-FDA-CYBER-2023-IV";
|
|
32
|
-
attribute :>> name = "FDACyberSectionIV";
|
|
33
|
-
attribute :>> clauseNumber = "IV";
|
|
34
|
-
attribute :>> title = "general cybersecurity principles";
|
|
35
|
-
attribute :>> normativeStrength = "informative";
|
|
36
|
-
}
|
|
37
|
-
item fdaCyberSection5 : StandardClause {
|
|
38
|
-
attribute :>> id = "STD-FDA-CYBER-2023-V";
|
|
39
|
-
attribute :>> name = "FDACyberSectionV";
|
|
40
|
-
attribute :>> clauseNumber = "V";
|
|
41
|
-
attribute :>> title = "secure product development framework";
|
|
42
|
-
attribute :>> normativeStrength = "informative";
|
|
43
|
-
}
|
|
44
|
-
item fdaCyberSection5A : StandardClause {
|
|
45
|
-
attribute :>> id = "STD-FDA-CYBER-2023-V-A";
|
|
46
|
-
attribute :>> name = "FDACyberSectionVA";
|
|
47
|
-
attribute :>> clauseNumber = "V.A";
|
|
48
|
-
attribute :>> title = "security risk management";
|
|
49
|
-
attribute :>> normativeStrength = "informative";
|
|
50
|
-
}
|
|
51
|
-
item fdaCyberSection5B : StandardClause {
|
|
52
|
-
attribute :>> id = "STD-FDA-CYBER-2023-V-B";
|
|
53
|
-
attribute :>> name = "FDACyberSectionVB";
|
|
54
|
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attribute :>> clauseNumber = "V.B";
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attribute :>> title = "security architecture";
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attribute :>> normativeStrength = "informative";
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}
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item fdaCyberSection5C : StandardClause {
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attribute :>> id = "STD-FDA-CYBER-2023-V-C";
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attribute :>> name = "FDACyberSectionVC";
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attribute :>> clauseNumber = "V.C";
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attribute :>> title = "cybersecurity testing";
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attribute :>> normativeStrength = "informative";
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}
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item fdaCyberSection6 : StandardClause {
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attribute :>> id = "STD-FDA-CYBER-2023-VI";
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attribute :>> name = "FDACyberSectionVI";
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attribute :>> clauseNumber = "VI";
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attribute :>> title = "cybersecurity transparency and vulnerability management";
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attribute :>> normativeStrength = "informative";
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}
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connection fdaCyberHas4 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection4;
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connection fdaCyberHas5 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection5;
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connection fdaCyberHas6 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection6;
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connection fdaCyberHas5A : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5A;
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connection fdaCyberHas5B : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5B;
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connection fdaCyberHas5C : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5C;
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}
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@@ -15,135 +15,122 @@ package memo_artifacts_standards_iec_60601_1 {
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15
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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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attribute :>> name = "IEC60601_1Clause4_3";
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attribute :>> clauseNumber = "4.3";
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attribute :>> title = "essential performance identification";
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attribute :>> normativeStrength = "shall";
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}
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}
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item iec60601_1Clause5 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1-5"; }
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attribute :>> name = "IEC60601_1Clause5";
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attribute :>> clauseNumber = "5";
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attribute :>> title = "general requirements for testing";
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attribute :>> normativeStrength = "shall";
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}
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item iec60601_1Clause7 : StandardClause {
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@MemoIdentity { :>> providedId = "STD-IEC-60601-1-7"; }
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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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attribute :>> name = "IEC60601_1Clause8";
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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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+
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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+
item iec60601_1Clause10 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-10"; }
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attribute :>> name = "IEC60601_1Clause10";
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attribute :>> clauseNumber = "10";
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attribute :>> title = "protection against unwanted and excessive radiation";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause11 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-11"; }
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+
attribute :>> name = "IEC60601_1Clause11";
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+
attribute :>> clauseNumber = "11";
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+
attribute :>> title = "protection against excessive temperatures and related hazards";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause12 : StandardClause {
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|
91
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-12"; }
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+
attribute :>> name = "IEC60601_1Clause12";
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+
attribute :>> clauseNumber = "12";
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+
attribute :>> title = "accuracy of controls and protection against hazardous output";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause13 : StandardClause {
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98
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-13"; }
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+
attribute :>> name = "IEC60601_1Clause13";
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+
attribute :>> clauseNumber = "13";
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+
attribute :>> title = "hazardous situations and fault conditions";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause14 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-14"; }
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+
attribute :>> name = "IEC60601_1Clause14";
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+
attribute :>> clauseNumber = "14";
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+
attribute :>> title = "programmable electrical medical systems";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause15 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-15"; }
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+
attribute :>> name = "IEC60601_1Clause15";
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+
attribute :>> clauseNumber = "15";
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+
attribute :>> title = "construction of medical electrical equipment";
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+
attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause16 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-16"; }
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attribute :>> name = "IEC60601_1Clause16";
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+
attribute :>> clauseNumber = "16";
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attribute :>> title = "medical electrical systems";
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attribute :>> normativeStrength = "shall";
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+
}
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+
item iec60601_1Clause17 : StandardClause {
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+
@MemoIdentity { :>> providedId = "STD-IEC-60601-1-17"; }
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+
attribute :>> name = "IEC60601_1Clause17";
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+
attribute :>> clauseNumber = "17";
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+
attribute :>> title = "electromagnetic compatibility";
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attribute :>> normativeStrength = "shall";
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+
}
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25
132
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}
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133
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27
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item iec60601_1Clause4 : StandardClause {
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attribute :>> id = "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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}
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item iec60601_1Clause4_2 : StandardClause {
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attribute :>> id = "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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attribute :>> id = "STD-IEC-60601-1-4-3";
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attribute :>> name = "IEC60601_1Clause4_3";
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attribute :>> clauseNumber = "4.3";
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attribute :>> title = "essential performance identification";
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attribute :>> normativeStrength = "shall";
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-
}
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item iec60601_1Clause5 : StandardClause {
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attribute :>> id = "STD-IEC-60601-1-5";
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attribute :>> name = "IEC60601_1Clause5";
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attribute :>> clauseNumber = "5";
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attribute :>> title = "general requirements for testing";
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attribute :>> normativeStrength = "shall";
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}
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item iec60601_1Clause7 : StandardClause {
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56
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attribute :>> id = "STD-IEC-60601-1-7";
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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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63
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attribute :>> id = "STD-IEC-60601-1-8";
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64
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attribute :>> name = "IEC60601_1Clause8";
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65
|
-
attribute :>> clauseNumber = "8";
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66
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-
attribute :>> title = "protection against electrical hazards";
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67
|
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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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70
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attribute :>> id = "STD-IEC-60601-1-9";
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71
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attribute :>> name = "IEC60601_1Clause9";
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72
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attribute :>> clauseNumber = "9";
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73
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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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77
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attribute :>> id = "STD-IEC-60601-1-10";
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78
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attribute :>> name = "IEC60601_1Clause10";
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attribute :>> clauseNumber = "10";
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attribute :>> title = "protection against unwanted and excessive radiation";
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81
|
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attribute :>> normativeStrength = "shall";
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}
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83
|
-
item iec60601_1Clause11 : StandardClause {
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84
|
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attribute :>> id = "STD-IEC-60601-1-11";
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85
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attribute :>> name = "IEC60601_1Clause11";
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86
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attribute :>> clauseNumber = "11";
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attribute :>> title = "protection against excessive temperatures and related hazards";
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88
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attribute :>> normativeStrength = "shall";
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}
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90
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-
item iec60601_1Clause12 : StandardClause {
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91
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attribute :>> id = "STD-IEC-60601-1-12";
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92
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attribute :>> name = "IEC60601_1Clause12";
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93
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attribute :>> clauseNumber = "12";
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94
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attribute :>> title = "accuracy of controls and protection against hazardous output";
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95
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attribute :>> normativeStrength = "shall";
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}
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97
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-
item iec60601_1Clause13 : StandardClause {
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98
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attribute :>> id = "STD-IEC-60601-1-13";
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99
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attribute :>> name = "IEC60601_1Clause13";
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100
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attribute :>> clauseNumber = "13";
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101
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attribute :>> title = "hazardous situations and fault conditions";
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102
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attribute :>> normativeStrength = "shall";
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103
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}
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104
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item iec60601_1Clause14 : StandardClause {
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|
105
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attribute :>> id = "STD-IEC-60601-1-14";
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106
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attribute :>> name = "IEC60601_1Clause14";
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107
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attribute :>> clauseNumber = "14";
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108
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attribute :>> title = "programmable electrical medical systems";
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109
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attribute :>> normativeStrength = "shall";
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110
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}
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111
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-
item iec60601_1Clause15 : StandardClause {
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112
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attribute :>> id = "STD-IEC-60601-1-15";
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113
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attribute :>> name = "IEC60601_1Clause15";
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114
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attribute :>> clauseNumber = "15";
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115
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attribute :>> title = "construction of medical electrical equipment";
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116
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attribute :>> normativeStrength = "shall";
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117
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}
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118
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item iec60601_1Clause16 : StandardClause {
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119
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attribute :>> id = "STD-IEC-60601-1-16";
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120
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attribute :>> name = "IEC60601_1Clause16";
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121
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attribute :>> clauseNumber = "16";
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122
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attribute :>> title = "medical electrical systems";
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123
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attribute :>> normativeStrength = "shall";
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124
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}
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125
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-
item iec60601_1Clause17 : StandardClause {
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126
|
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attribute :>> id = "STD-IEC-60601-1-17";
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127
|
-
attribute :>> name = "IEC60601_1Clause17";
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128
|
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attribute :>> clauseNumber = "17";
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129
|
-
attribute :>> title = "electromagnetic compatibility";
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|
130
|
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attribute :>> normativeStrength = "shall";
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|
131
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-
}
|
|
132
134
|
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|
133
|
-
connection iec60601_1Has4 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause4;
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134
|
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connection iec60601_1Has5 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause5;
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135
|
-
connection iec60601_1Has7 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause7;
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|
136
|
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connection iec60601_1Has8 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause8;
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137
|
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connection iec60601_1Has9 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause9;
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138
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connection iec60601_1Has10 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause10;
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139
|
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connection iec60601_1Has11 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause11;
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140
|
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connection iec60601_1Has12 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause12;
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141
|
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connection iec60601_1Has13 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause13;
|
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142
|
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connection iec60601_1Has14 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause14;
|
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143
|
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connection iec60601_1Has15 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause15;
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144
|
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connection iec60601_1Has16 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause16;
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145
|
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connection iec60601_1Has17 : Composes connect parent ::> iec60601_1 to child ::> iec60601_1Clause17;
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|
146
135
|
|
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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
|
}
|