@memoarchitect/ontology 0.4.6 → 0.6.1
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 +7 -6
- package/examples/connected-patient-monitor/README.md +7 -0
- package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +70 -0
- package/examples/connected-patient-monitor/model/connected_patient_monitor.sysml +3 -0
- package/examples/connected-patient-monitor/model/viewpoints/connected_patient_monitor_overview.sysml +6 -0
- package/examples/embedded-infusion-pump/README.md +7 -0
- package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +66 -0
- package/examples/embedded-infusion-pump/model/embedded_infusion_pump.sysml +3 -0
- package/examples/embedded-infusion-pump/model/viewpoints/embedded_infusion_pump_overview.sysml +6 -0
- package/examples/extensions/README.md +16 -0
- package/examples/extensions/clinical/memo.package.yaml +9 -0
- package/examples/extensions/clinical/src/clinical_extension.sysml +3 -0
- package/examples/extensions/clinical/src/methodology/clinical_methodology.sysml +14 -0
- package/examples/extensions/clinical/src/procedures/memo_clinical_procedures.sysml +16 -0
- package/examples/extensions/template/memo.package.yaml +9 -0
- package/examples/extensions/template/src/extension.sysml +15 -0
- package/examples/functional-logical-physical/README.md +7 -0
- package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +50 -0
- package/examples/functional-logical-physical/model/functional_logical_physical.sysml +3 -0
- package/examples/functional-logical-physical/model/viewpoints/functional_logical_physical_overview.sysml +6 -0
- package/examples/gpca-pump/README.md +26 -0
- package/examples/gpca-pump/dhf/documents/DOC-RMP-001.md +1 -1
- package/examples/gpca-pump/memo.config.yaml +2 -2
- package/examples/gpca-pump/methodology/gpca_profiles.sysml +1 -1
- package/examples/gpca-pump/methodology/gpca_scope.sysml +2 -2
- package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +10 -10
- package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +17 -6
- package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +11 -11
- package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +35 -22
- package/examples/gpca-pump/model/catalog/gpca_context.sysml +25 -6
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +6 -6
- package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +29 -15
- package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +293 -169
- package/examples/gpca-pump/model/catalog/gpca_operational.sysml +145 -27
- package/examples/gpca-pump/model/catalog/gpca_physical.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +210 -105
- package/examples/gpca-pump/model/catalog/gpca_risk.sysml +66 -69
- package/examples/gpca-pump/model/catalog/gpca_system.sysml +43 -76
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +73 -70
- package/examples/gpca-pump/model/catalog/gpca_verification.sysml +27 -27
- package/examples/gpca-pump/model/views/context_system_context_view.sysml +2 -2
- package/examples/gpca-pump/model/views/document_architecture_description_view.sysml +2 -2
- package/examples/gpca-pump/model/views/document_cyber_assessment_view.sysml +2 -2
- package/examples/gpca-pump/model/views/document_hazard_analysis_view.sysml +1 -1
- package/examples/gpca-pump/model/views/document_rmf_view.sysml +2 -2
- package/examples/gpca-pump/model/views/document_sdd_view.sysml +2 -2
- package/examples/gpca-pump/model/views/document_threat_model_view.sysml +1 -1
- package/examples/gpca-pump/model/views/document_usability_view.sysml +1 -1
- package/examples/gpca-pump/model/views/document_vv_view.sysml +1 -1
- package/examples/gpca-pump/model/views/functional_function_allocation_view.sysml +1 -1
- package/examples/gpca-pump/model/views/functional_function_browser_view.sysml +1 -1
- package/examples/gpca-pump/model/views/logical_device_interconnect_view.sysml +1 -1
- package/examples/gpca-pump/model/views/logical_mode_state_view.sysml +1 -1
- package/examples/gpca-pump/model/views/logical_system_decomposition_view.sysml +1 -1
- package/examples/gpca-pump/model/views/operational_scenario_sequence_view.sysml +1 -1
- package/examples/gpca-pump/model/views/operational_use_case_view.sysml +6 -6
- package/examples/gpca-pump/model/views/physical_physical_bom_view.sysml +1 -1
- package/examples/gpca-pump/model/views/requirements_requirements_trace_view.sysml +1 -1
- package/examples/gpca-pump/model/views/risk_risk_chain_view.sysml +2 -2
- package/examples/gpca-pump/model/views/software_software_architecture_view.sysml +1 -1
- package/examples/gpca-pump/model/views/verification_verification_coverage_view.sysml +1 -1
- package/examples/ivd-laboratory-system/README.md +7 -0
- package/examples/ivd-laboratory-system/model/catalog/ivd_laboratory_system.sysml +58 -0
- package/examples/ivd-laboratory-system/model/ivd_laboratory_system.sysml +3 -0
- package/examples/ivd-laboratory-system/model/viewpoints/ivd_laboratory_system_overview.sysml +6 -0
- package/examples/manual-surgical-instrument/README.md +7 -0
- package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +41 -0
- package/examples/manual-surgical-instrument/model/manual_surgical_instrument.sysml +3 -0
- package/examples/manual-surgical-instrument/model/viewpoints/manual_surgical_instrument_overview.sysml +6 -0
- package/examples/multidimensional-layers/README.md +7 -0
- package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +51 -0
- package/examples/multidimensional-layers/model/multidimensional_layers.sysml +4 -0
- package/examples/multidimensional-layers/model/viewpoints/multidimensional_layers_overview.sysml +13 -0
- package/examples/reusable-instrument/README.md +7 -0
- package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +71 -0
- package/examples/reusable-instrument/model/reusable_instrument.sysml +4 -0
- package/examples/reusable-instrument/model/viewpoints/reusable_instrument_overview.sysml +13 -0
- package/examples/software-only-medical-device/README.md +7 -0
- package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +62 -0
- package/examples/software-only-medical-device/model/software_only_medical_device.sysml +4 -0
- package/examples/software-only-medical-device/model/viewpoints/software_only_medical_device_overview.sysml +13 -0
- package/examples/surgical-closure-workflow/README.md +8 -0
- package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +151 -0
- package/examples/surgical-closure-workflow/model/surgical_closure_workflow.sysml +4 -0
- package/examples/surgical-closure-workflow/model/viewpoints/surgical_closure_workflow_overview.sysml +13 -0
- package/examples/surgical-robot/README.md +7 -0
- package/examples/surgical-robot/model/catalog/surgical_robot.sysml +58 -0
- package/examples/surgical-robot/model/surgical_robot.sysml +4 -0
- package/examples/surgical-robot/model/viewpoints/surgical_robot_overview.sysml +13 -0
- package/examples/sysml-diagram-samples/README.md +32 -0
- package/examples/sysml-diagram-samples/memo.package.yaml +5 -0
- package/examples/{gpca-pump → sysml-diagram-samples}/model/samples/action_flow_view.sysml +22 -4
- package/examples/sysml-diagram-samples/model/samples/context_view.sysml +55 -0
- package/examples/{gpca-pump → sysml-diagram-samples}/model/samples/functional_flow_view.sysml +17 -6
- package/examples/{gpca-pump → sysml-diagram-samples}/model/samples/interconnection_view.sysml +4 -3
- package/examples/{gpca-pump → sysml-diagram-samples}/model/samples/operational_behaviour_view.sysml +32 -42
- package/examples/sysml-diagram-samples/model/samples/requirements_view.sysml +63 -0
- package/examples/sysml-diagram-samples/model/samples/state_transition_view.sysml +109 -0
- package/examples/{gpca-pump → sysml-diagram-samples}/model/samples/tree_view.sysml +3 -3
- package/examples/sysml-diagram-samples/model/samples/use_case_view.sysml +81 -0
- package/examples/temperature-alarm/README.md +7 -0
- package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +140 -0
- package/examples/temperature-alarm/model/temperature_alarm.sysml +4 -0
- package/examples/temperature-alarm/model/viewpoints/temperature_alarm_overview.sysml +13 -0
- package/memo.manifest.yaml +12 -4
- package/methodologies/default/memo.package.yaml +1 -1
- package/methodologies/gpca/memo.package.yaml +4 -4
- package/ontology/memo.package.yaml +1 -1
- package/ontology/memo.rendering.yaml +37 -0
- package/package.json +19 -11
- package/profile/memo.package.yaml +3 -3
- package/src/architecture/decisions/memo_decisions.sysml +1 -1
- package/src/architecture/{behavior → functional/behavior}/memo_behavior.sysml +12 -11
- package/src/architecture/{constraints → functional/constraints}/memo_constraints.sysml +2 -2
- package/src/architecture/functional/functions/memo_functions.sysml +81 -0
- package/src/architecture/implementation/hardware/common/memo_hardware_common.sysml +46 -0
- package/src/architecture/implementation/hardware/electrical/memo_hardware_electrical.sysml +36 -0
- package/src/architecture/implementation/hardware/fluidic/memo_hardware_fluidic.sysml +14 -0
- package/src/architecture/implementation/hardware/mechanical/memo_hardware_mechanical.sysml +14 -0
- package/src/architecture/implementation/hardware/optical/memo_hardware_optical.sysml +11 -0
- package/src/architecture/implementation/hardware/sensing/memo_hardware_sensing.sysml +17 -0
- package/src/architecture/implementation/hardware/structure/memo_hardware_structure.sysml +12 -0
- package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +70 -0
- package/src/architecture/implementation/software/structure/memo_software_structure.sysml +80 -0
- package/src/architecture/implementation/ui/memo_ui.sysml +159 -0
- package/src/architecture/logical/interfaces/memo_interfaces.sysml +102 -0
- package/src/architecture/logical/structure/memo_logical_structure.sysml +150 -0
- package/src/architecture/operational/activities/memo_activities.sysml +86 -0
- package/src/architecture/operational/context/actors/memo_actors.sysml +38 -0
- package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +64 -0
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +53 -0
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +116 -0
- package/src/architecture/operational/structure/memo_operational.sysml +31 -0
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +67 -0
- package/src/architecture/operational/workflows/memo_workflows.sysml +126 -0
- package/src/architecture/realization/deployment/memo_deployment.sysml +90 -0
- package/src/architecture/{physical → realization/physical}/memo_physical_architecture.sysml +12 -1
- package/src/artifacts/definitions/memo_artifact_definitions.sysml +1 -1
- package/src/{architecture → assurance}/cybersecurity/memo_cybersecurity.sysml +14 -10
- package/src/assurance/human_factors/memo_human_factors.sysml +50 -0
- package/src/{architecture → assurance}/requirements/memo_requirements.sysml +45 -21
- package/src/assurance/requirements/needs/memo_needs.sysml +43 -0
- package/src/{architecture → assurance/safety_risk}/analysis/memo_fmea.sysml +13 -13
- package/src/{architecture/risk → assurance/safety_risk}/memo_arch_risk.sysml +2 -2
- package/src/{architecture/risk → assurance/safety_risk}/memo_risk.sysml +25 -16
- package/src/assurance/verification_validation/memo_assurance.sysml +49 -0
- package/src/compliance/artifacts/memo_artifacts.sysml +1 -1
- package/src/compliance/change/memo_change.sysml +2 -2
- package/src/compliance/dhf-templates/21cfr820/design-input.md +1 -1
- package/src/compliance/dhf-templates/21cfr820/design-validation.md +1 -1
- package/src/compliance/dhf-templates/21cfr820/user-needs.md +2 -2
- package/src/compliance/dhf-templates/iec-62366/urra.md +1 -1
- package/src/compliance/dhf-templates/iso-14971/fmea.md +1 -1
- package/src/compliance/dhf-templates/iso-14971/har.md +4 -4
- package/src/compliance/dhf-templates/iso-14971/risk-matrix.md +1 -1
- package/src/compliance/dhf-templates/iso-14971/rmp.md +1 -1
- package/src/compliance/dhf-templates/iso-14971/rmr.md +1 -1
- package/src/compliance/iso14971/risk_management_file.sysml +1 -1
- package/src/compliance/postmarket/memo_postmarket.sysml +2 -2
- package/src/core/common/memo_common.sysml +123 -14
- package/src/core/consistency_rules/consistency_rules.sysml +2 -2
- package/src/core/dimensions/dimensions.sysml +45 -24
- package/src/core/enumerations/memo_enumerations.sysml +11 -16
- package/src/core/methodology_scope/methodology_scope.sysml +10 -28
- package/src/core/relationships/memo_relationships.sysml +178 -146
- package/src/core/stdlib/{collections.sysml → collections/collections.sysml} +1 -1
- package/src/core/stdlib/{functions.sysml → functions/functions.sysml} +1 -1
- package/src/core/stdlib/{scalars.sysml → scalars/scalars.sysml} +1 -1
- package/src/core/stdlib/{time.sysml → time/time.sysml} +1 -1
- package/src/core/terminology/terminology.sysml +35 -0
- package/src/memo_namespaces.sysml +247 -302
- package/src/methodology/{memo_core.sysml → core/memo_core.sysml} +19 -13
- package/src/methodology/{memo_gates.sysml → gates/memo_gates.sysml} +1 -1
- package/src/methodology/{memo_patterns.sysml → patterns/memo_patterns.sysml} +1 -1
- package/src/methodology/{memo_profiles.sysml → profiles/memo_profiles.sysml} +27 -35
- package/src/methodology/{memo_workflow.sysml → workflow/memo_workflow.sysml} +1 -1
- package/src/rules/closure/closure_rules.sysml +11 -11
- package/src/rules/coverage/coverage_rules.sysml +8 -8
- package/src/rules/crosslayer/cross_layer_rules.sysml +2 -2
- package/src/rules/lifecycle/lifecycle_rules.sysml +1 -1
- package/src/rules/ontology/ontology_invariants.sysml +133 -0
- package/src/rules/quantitative/quantitative_rules.sysml +2 -2
- package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +189 -0
- package/src/viewpoints/clinical/clinical_viewpoint.sysml +0 -1
- package/src/viewpoints/context/context_viewpoint.sysml +1 -2
- package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +1 -2
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +8 -8
- package/src/viewpoints/functional/{function_allocation_view.sysml → function_allocation_view/function_allocation_view.sysml} +1 -1
- package/src/viewpoints/functional/functional_viewpoint.sysml +2 -3
- package/src/viewpoints/functional/{system_functional_tree_view.sysml → system_functional_tree_view/system_functional_tree_view.sysml} +1 -1
- package/src/viewpoints/logical/logical_viewpoint.sysml +0 -1
- package/src/viewpoints/operational/operational_viewpoint.sysml +1 -2
- package/src/viewpoints/operational/{use_case_view.sysml → use_case_view/use_case_view.sysml} +1 -1
- package/src/viewpoints/physical/physical_viewpoint.sysml +0 -1
- package/src/viewpoints/requirements/{requirements_traceability_view.sysml → requirements_traceability_view/requirements_traceability_view.sysml} +1 -1
- package/src/viewpoints/requirements/requirements_viewpoint.sysml +1 -2
- package/src/viewpoints/risk/{risk_chain_view.sysml → risk_chain_view/risk_chain_view.sysml} +2 -2
- package/src/viewpoints/risk/risk_viewpoint.sysml +1 -2
- package/src/viewpoints/software/{software_architecture_view.sysml → software_architecture_view/software_architecture_view.sysml} +1 -1
- package/src/viewpoints/software/software_viewpoint.sysml +1 -2
- package/src/viewpoints/usability/usability_viewpoint.sysml +0 -1
- package/src/viewpoints/verification/verification_viewpoint.sysml +0 -1
- package/templates/connected-device/memo.package.yaml +5 -0
- package/templates/connected-device/src/architecture/system.sysml +5 -0
- package/templates/connected-device/src/artifacts/artifacts.sysml +5 -0
- package/templates/connected-device/src/assurance/requirements.sysml +7 -0
- package/templates/default/memo.package.yaml +5 -0
- package/templates/default/src/architecture/system.sysml +7 -0
- package/templates/default/src/artifacts/artifacts.sysml +5 -0
- package/templates/default/src/assurance/requirements.sysml +8 -0
- package/templates/infusion-pump/memo.package.yaml +5 -0
- package/templates/infusion-pump/src/architecture/system.sysml +5 -0
- package/templates/infusion-pump/src/artifacts/artifacts.sysml +5 -0
- package/templates/infusion-pump/src/assurance/requirements.sysml +7 -0
- package/templates/monitoring-device/memo.package.yaml +5 -0
- package/templates/monitoring-device/src/architecture/system.sysml +5 -0
- package/templates/monitoring-device/src/artifacts/artifacts.sysml +5 -0
- package/templates/monitoring-device/src/assurance/requirements.sysml +7 -0
- package/templates/samd/memo.package.yaml +5 -0
- package/templates/samd/src/architecture/system.sysml +5 -0
- package/templates/samd/src/artifacts/artifacts.sysml +5 -0
- package/templates/samd/src/assurance/requirements.sysml +7 -0
- package/examples/gpca-pump/model/samples/README.md +0 -24
- package/examples/gpca-pump/model/samples/action_flow_view.viewlayout +0 -9
- package/examples/gpca-pump/model/samples/interconnection_view.viewlayout +0 -99
- package/profile/archetypes.yaml +0 -36
- package/profile/templates/connected-device/starter.sysml +0 -8
- package/profile/templates/infusion-pump/starter.sysml +0 -8
- package/profile/templates/monitoring-device/starter.sysml +0 -8
- package/profile/templates/samd/starter.sysml +0 -8
- package/src/architecture/assurance/memo_assurance.sysml +0 -29
- package/src/architecture/context/memo_context.sysml +0 -58
- package/src/architecture/functions/memo_functions.sysml +0 -30
- package/src/architecture/hardware_structure/memo_hardware_structure.sysml +0 -15
- package/src/architecture/interfaces/memo_interfaces.sysml +0 -103
- package/src/architecture/logical_structure/memo_logical_structure.sysml +0 -10
- package/src/architecture/operational/memo_operational.sysml +0 -51
- package/src/architecture/software_structure/memo_software_structure.sysml +0 -44
- package/src/architecture/system/memo_system_analysis.sysml +0 -54
- package/src/artifacts/clinical_safety_report.sysml +0 -12
- package/src/artifacts/cybersecurity_assessment_report.sysml +0 -12
- package/src/artifacts/design_change_log.sysml +0 -12
- package/src/artifacts/design_history_file_index.sysml +0 -12
- package/src/artifacts/design_input_plan.sysml +0 -12
- package/src/artifacts/design_output_plan.sysml +0 -12
- package/src/artifacts/evidence_record.sysml +0 -12
- package/src/artifacts/failure_mode_effects_analysis.sysml +0 -12
- package/src/artifacts/hazard_analysis_report.sysml +0 -12
- package/src/artifacts/labeling_specification.sysml +0 -12
- package/src/artifacts/requirements_specification.sysml +0 -12
- package/src/artifacts/requirements_traceability_matrix.sysml +0 -12
- package/src/artifacts/risk_management_plan.sysml +0 -12
- package/src/artifacts/software_design_description.sysml +0 -12
- package/src/artifacts/software_development_plan.sysml +0 -12
- package/src/artifacts/soup_list.sysml +0 -12
- package/src/artifacts/system_architecture_description.sysml +0 -12
- package/src/artifacts/test_protocol.sysml +0 -12
- package/src/artifacts/test_report.sysml +0 -12
- package/src/artifacts/threat_model_report.sysml +0 -12
- package/src/artifacts/usability_engineering_report.sysml +0 -12
- package/src/medical_device_library.sysml +0 -100
- package/template/memo.package.yaml +0 -5
- package/template/src/catalog/starter.sysml +0 -12
- package/template/src/documents/.gitkeep +0 -1
- package/template/src/views/.gitkeep +0 -1
- /package/src/methodology/{memo_archetypes.sysml → archetypes/memo_archetypes.sysml} +0 -0
- /package/src/methodology/{memo_rules.sysml → rules/memo_rules.sysml} +0 -0
- /package/src/methodology/{memo_viewpoints.sysml → viewpoints/memo_viewpoints.sysml} +0 -0
- /package/src/viewpoints/clinical/{clinical_evidence_view.sysml → clinical_evidence_view/clinical_evidence_view.sysml} +0 -0
- /package/src/viewpoints/context/{system_context_view.sysml → system_context_view/system_context_view.sysml} +0 -0
- /package/src/viewpoints/cybersecurity/{cybersecurity_assessment_view.sysml → cybersecurity_assessment_view/cybersecurity_assessment_view.sysml} +0 -0
- /package/src/viewpoints/cybersecurity/{threat_model_view.sysml → threat_model_view/threat_model_view.sysml} +0 -0
- /package/src/viewpoints/logical/{logical_architecture_view.sysml → logical_architecture_view/logical_architecture_view.sysml} +0 -0
- /package/src/viewpoints/physical/{network_topology_view.sysml → network_topology_view/network_topology_view.sysml} +0 -0
- /package/src/viewpoints/physical/{physical_bom_view.sysml → physical_bom_view/physical_bom_view.sysml} +0 -0
- /package/src/viewpoints/usability/{usability_engineering_view.sysml → usability_engineering_view/usability_engineering_view.sysml} +0 -0
- /package/src/viewpoints/verification/{verification_coverage_view.sysml → verification_coverage_view/verification_coverage_view.sysml} +0 -0
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package memo_artifacts_evidence_record {
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private import ScalarValues::*;
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private import memo_artifacts_definitions::*;
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private import memo_core_enumerations::*;
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part def EvidenceRecord specializes ArtifactKindDef {
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attribute :>> documentTitle = "Evidence Record";
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attribute :>> regulatoryRef = "21 CFR 820.30";
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attribute :>> artifactKind = ArtifactKind::evidenceRecord;
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}
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}
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package memo_artifacts_failure_mode_effects_analysis {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
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6
|
-
|
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7
|
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part def FailureModeEffectsAnalysisReport specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Failure Mode and Effects Analysis";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 60812:2018";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::failureModeEffectsAnalysis;
|
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11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
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1
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-
package memo_artifacts_hazard_analysis_report {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
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private import memo_core_enumerations::*;
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6
|
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|
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7
|
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part def HazardAnalysisReport specializes ArtifactKindDef {
|
|
8
|
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attribute :>> documentTitle = "Hazard Analysis Report";
|
|
9
|
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attribute :>> regulatoryRef = "ISO 14971:2019 §5-6";
|
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10
|
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attribute :>> artifactKind = ArtifactKind::riskRecord;
|
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11
|
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}
|
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12
|
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}
|
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@@ -1,12 +0,0 @@
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1
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-
package memo_artifacts_labeling_specification {
|
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2
|
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private import ScalarValues::*;
|
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3
|
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|
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4
|
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private import memo_artifacts_definitions::*;
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|
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private import memo_core_enumerations::*;
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|
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7
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part def LabelingSpecification specializes ArtifactKindDef {
|
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8
|
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attribute :>> documentTitle = "Labeling Specification";
|
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9
|
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attribute :>> regulatoryRef = "21 CFR 801 / MDR Annex I §23";
|
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10
|
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attribute :>> artifactKind = ArtifactKind::labelingSpecification;
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11
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}
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}
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@@ -1,12 +0,0 @@
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1
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package memo_artifacts_requirements_specification {
|
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2
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private import ScalarValues::*;
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3
|
-
|
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4
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private import memo_artifacts_definitions::*;
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|
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private import memo_core_enumerations::*;
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6
|
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7
|
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part def RequirementsSpecification specializes ArtifactKindDef {
|
|
8
|
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attribute :>> documentTitle = "Requirements Specification";
|
|
9
|
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attribute :>> regulatoryRef = "ISO 13485:2016 §7.3.3";
|
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|
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attribute :>> artifactKind = ArtifactKind::requirementSpecification;
|
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11
|
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}
|
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12
|
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}
|
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@@ -1,12 +0,0 @@
|
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1
|
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package memo_artifacts_requirements_traceability_matrix {
|
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2
|
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private import ScalarValues::*;
|
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3
|
-
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4
|
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private import memo_artifacts_definitions::*;
|
|
5
|
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private import memo_core_enumerations::*;
|
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6
|
-
|
|
7
|
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part def RequirementsTraceabilityMatrix specializes ArtifactKindDef {
|
|
8
|
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attribute :>> documentTitle = "Requirements Traceability Matrix";
|
|
9
|
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attribute :>> regulatoryRef = "IEC 62304:2006 §5.1.1";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::traceMatrix;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_risk_management_plan {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def RiskManagementPlan specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Risk Management Plan";
|
|
9
|
-
attribute :>> regulatoryRef = "ISO 14971:2019 §4.4";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::plan;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_software_design_description {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def SoftwareDesignDescription specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Software Design Description";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 62304:2006 §5.4";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::softwareDesignDescription;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_software_development_plan {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def SoftwareDevelopmentPlan specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Software Development Plan";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 62304:2006 §5.1";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::softwareDevelopmentPlan;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_soup_list {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def SoupList specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "SOUP List (Software of Unknown Provenance)";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 62304:2006 §8.1.2";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::soupList;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_system_architecture_description {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def SystemArchitectureDescription specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "System Architecture Description";
|
|
9
|
-
attribute :>> regulatoryRef = "ISO/IEC/IEEE 42010:2022";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::architectureDescription;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_test_protocol {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def TestProtocol specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Test Protocol";
|
|
9
|
-
attribute :>> regulatoryRef = "ISO 13485:2016 §7.3.6";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::testProtocol;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_test_report {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def TestReport specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Test Report";
|
|
9
|
-
attribute :>> regulatoryRef = "ISO 13485:2016 §7.3.7";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::testReport;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_threat_model_report {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def ThreatModelReport specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Threat Model";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 81001-5-1:2021";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::threatModel;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_artifacts_usability_engineering_report {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
private import memo_artifacts_definitions::*;
|
|
5
|
-
private import memo_core_enumerations::*;
|
|
6
|
-
|
|
7
|
-
part def UsabilityEngineeringReport specializes ArtifactKindDef {
|
|
8
|
-
attribute :>> documentTitle = "Usability Engineering Report";
|
|
9
|
-
attribute :>> regulatoryRef = "IEC 62366-1:2015";
|
|
10
|
-
attribute :>> artifactKind = ArtifactKind::usabilityEngineeringReport;
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1,100 +0,0 @@
|
|
|
1
|
-
package memo_medical_device_library {
|
|
2
|
-
private import ScalarValues::*;
|
|
3
|
-
|
|
4
|
-
public import memo_core_enumerations::*;
|
|
5
|
-
public import memo_core_common::*;
|
|
6
|
-
public import memo_core_relationships::*;
|
|
7
|
-
|
|
8
|
-
public import memo_architecture_context::*;
|
|
9
|
-
public import memo_architecture_operational::*;
|
|
10
|
-
public import memo_architecture_system::*;
|
|
11
|
-
public import memo_architecture_requirements::*;
|
|
12
|
-
public import memo_architecture_functions::*;
|
|
13
|
-
public import memo_architecture_logical_structure::*;
|
|
14
|
-
public import memo_architecture_interfaces::*;
|
|
15
|
-
public import memo_architecture_behavior::*;
|
|
16
|
-
public import memo_architecture_software_structure::*;
|
|
17
|
-
public import memo_architecture_hardware_structure::*;
|
|
18
|
-
public import memo_architecture_constraints::*;
|
|
19
|
-
public import memo_architecture_risk_risk::*;
|
|
20
|
-
public import memo_architecture_cybersecurity::*;
|
|
21
|
-
public import memo_architecture_assurance::*;
|
|
22
|
-
public import memo_architecture_physical::*;
|
|
23
|
-
public import memo_architecture_analysis::*;
|
|
24
|
-
public import memo_architecture_decisions::*;
|
|
25
|
-
|
|
26
|
-
public import memo_viewpoints_definitions::*;
|
|
27
|
-
|
|
28
|
-
public import memo_viewpoints_context_context_viewpoint::*;
|
|
29
|
-
public import memo_viewpoints_context_system_context_view::*;
|
|
30
|
-
|
|
31
|
-
public import memo_viewpoints_operational_operational_viewpoint::*;
|
|
32
|
-
public import memo_viewpoints_operational_use_case_view::*;
|
|
33
|
-
|
|
34
|
-
public import memo_viewpoints_requirements_requirements_viewpoint::*;
|
|
35
|
-
public import memo_viewpoints_requirements_requirements_traceability_view::*;
|
|
36
|
-
|
|
37
|
-
public import memo_viewpoints_functional_functional_viewpoint::*;
|
|
38
|
-
public import memo_viewpoints_functional_system_functional_tree_view::*;
|
|
39
|
-
public import memo_viewpoints_functional_function_allocation_view::*;
|
|
40
|
-
|
|
41
|
-
public import memo_viewpoints_logical_logical_viewpoint::*;
|
|
42
|
-
public import memo_viewpoints_logical_logical_architecture_view::*;
|
|
43
|
-
|
|
44
|
-
public import memo_viewpoints_software_software_viewpoint::*;
|
|
45
|
-
public import memo_viewpoints_software_software_architecture_view::*;
|
|
46
|
-
|
|
47
|
-
public import memo_viewpoints_physical_physical_viewpoint::*;
|
|
48
|
-
public import memo_viewpoints_physical_physical_bom_view::*;
|
|
49
|
-
public import memo_viewpoints_physical_network_topology_view::*;
|
|
50
|
-
|
|
51
|
-
public import memo_viewpoints_risk_risk_viewpoint::*;
|
|
52
|
-
public import memo_viewpoints_risk_risk_chain_view::*;
|
|
53
|
-
|
|
54
|
-
public import memo_viewpoints_verification_verification_viewpoint::*;
|
|
55
|
-
public import memo_viewpoints_verification_verification_coverage_view::*;
|
|
56
|
-
|
|
57
|
-
public import memo_viewpoints_cybersecurity_cybersecurity_viewpoint::*;
|
|
58
|
-
public import memo_viewpoints_cybersecurity_threat_model_view::*;
|
|
59
|
-
public import memo_viewpoints_cybersecurity_cybersecurity_assessment_view::*;
|
|
60
|
-
|
|
61
|
-
public import memo_viewpoints_clinical_clinical_viewpoint::*;
|
|
62
|
-
public import memo_viewpoints_clinical_clinical_evidence_view::*;
|
|
63
|
-
|
|
64
|
-
public import memo_viewpoints_usability_usability_viewpoint::*;
|
|
65
|
-
public import memo_viewpoints_usability_usability_engineering_view::*;
|
|
66
|
-
|
|
67
|
-
public import memo_artifacts_definitions::*;
|
|
68
|
-
public import memo_artifacts_risk_management_plan::*;
|
|
69
|
-
public import memo_artifacts_requirements_specification::*;
|
|
70
|
-
public import memo_artifacts_system_architecture_description::*;
|
|
71
|
-
public import memo_artifacts_software_design_description::*;
|
|
72
|
-
public import memo_artifacts_hazard_analysis_report::*;
|
|
73
|
-
public import memo_artifacts_requirements_traceability_matrix::*;
|
|
74
|
-
public import memo_artifacts_test_protocol::*;
|
|
75
|
-
public import memo_artifacts_test_report::*;
|
|
76
|
-
public import memo_artifacts_evidence_record::*;
|
|
77
|
-
public import memo_artifacts_cybersecurity_assessment_report::*;
|
|
78
|
-
public import memo_artifacts_threat_model_report::*;
|
|
79
|
-
public import memo_artifacts_usability_engineering_report::*;
|
|
80
|
-
public import memo_artifacts_clinical_safety_report::*;
|
|
81
|
-
public import memo_artifacts_failure_mode_effects_analysis::*;
|
|
82
|
-
public import memo_artifacts_soup_list::*;
|
|
83
|
-
public import memo_artifacts_design_input_plan::*;
|
|
84
|
-
public import memo_artifacts_design_output_plan::*;
|
|
85
|
-
public import memo_artifacts_software_development_plan::*;
|
|
86
|
-
public import memo_artifacts_labeling_specification::*;
|
|
87
|
-
public import memo_artifacts_design_history_file_index::*;
|
|
88
|
-
public import memo_artifacts_design_change_log::*;
|
|
89
|
-
public import memo_compliance_artifacts::*;
|
|
90
|
-
public import memo_compliance_change::*;
|
|
91
|
-
public import memo_compliance_postmarket::*;
|
|
92
|
-
|
|
93
|
-
public import memo_methodology_core::*;
|
|
94
|
-
public import memo_methodology_viewpoints::*;
|
|
95
|
-
public import memo_methodology_rules::*;
|
|
96
|
-
public import memo_methodology_patterns::*;
|
|
97
|
-
public import memo_methodology_workflow::*;
|
|
98
|
-
public import memo_methodology_gates::*;
|
|
99
|
-
public import memo_methodology_profiles::*;
|
|
100
|
-
}
|
|
@@ -1,12 +0,0 @@
|
|
|
1
|
-
package memo_starter_catalog {
|
|
2
|
-
import memo_medical_device_library::*;
|
|
3
|
-
|
|
4
|
-
part starterSystem : System {
|
|
5
|
-
attribute redefines name = "{{name}}";
|
|
6
|
-
}
|
|
7
|
-
|
|
8
|
-
requirement mainRequirement : Requirement {
|
|
9
|
-
attribute redefines title = "Main system requirement";
|
|
10
|
-
doc /* TODO: define the first system requirement. */
|
|
11
|
-
}
|
|
12
|
-
}
|
|
@@ -1 +0,0 @@
|
|
|
1
|
-
|
|
@@ -1 +0,0 @@
|
|
|
1
|
-
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|
|
File without changes
|