@memoarchitect/ontology 0.6.5 → 0.8.22
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/README.md +4 -2
- package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +1 -1
- package/examples/connected-patient-monitor/model/catalog/project.sysml +24 -0
- package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/connected-patient-monitor/model/{viewpoints → catalog/viewpoints/unassigned/views}/connected_patient_monitor_overview.sysml +1 -1
- package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +7 -5
- package/examples/embedded-infusion-pump/model/catalog/project.sysml +24 -0
- package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/embedded-infusion-pump/model/{viewpoints → catalog/viewpoints/unassigned/views}/embedded_infusion_pump_overview.sysml +1 -1
- package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +5 -5
- package/examples/functional-logical-physical/model/catalog/project.sysml +24 -0
- package/examples/functional-logical-physical/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/functional-logical-physical/model/{viewpoints → catalog/viewpoints/unassigned/views}/functional_logical_physical_overview.sysml +1 -1
- package/examples/gpca-pump/methodology/gpca_methodology.sysml +7 -8
- package/examples/gpca-pump/methodology/gpca_profiles.sysml +89 -11
- package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +19 -9
- package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +342 -100
- package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +27 -13
- package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +329 -272
- package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +57 -16
- package/examples/gpca-pump/model/catalog/gpca_context.sysml +12 -8
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +14 -10
- package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +1 -15
- package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +181 -264
- package/examples/gpca-pump/model/catalog/gpca_operational.sysml +95 -60
- package/examples/gpca-pump/model/catalog/gpca_physical.sysml +6 -11
- package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +102 -101
- package/examples/gpca-pump/model/catalog/gpca_risk.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_standards.sysml +161 -0
- package/examples/gpca-pump/model/catalog/gpca_system.sysml +47 -30
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +301 -354
- package/examples/gpca-pump/model/catalog/gpca_verification.sysml +116 -36
- package/examples/gpca-pump/model/catalog/project.sysml +26 -0
- package/examples/gpca-pump/model/catalog/viewpoints/context/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/context/views}/context_system_context_view.sysml +4 -4
- package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/cybersecurity_cybersecurity_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_cyber_assessment_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_threat_model_view.sysml +5 -5
- package/examples/gpca-pump/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_allocation_view.sysml +2 -2
- package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_browser_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/logical/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/behavior_action_flow_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/document_architecture_description_view.sysml +8 -8
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_device_interconnect_view.sysml +5 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_logical_architecture_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_mode_state_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_system_decomposition_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/operational/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_scenario_sequence_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_use_case_view.sysml +4 -4
- package/examples/gpca-pump/model/catalog/viewpoints/physical/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/physical/views}/physical_physical_bom_view.sysml +2 -2
- package/examples/gpca-pump/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/document_dhf_index_view.sysml +8 -8
- package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/requirements_requirements_trace_view.sysml +2 -2
- package/examples/gpca-pump/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_hazard_analysis_view.sysml +8 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_rmf_view.sysml +7 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_fmea_view.sysml +3 -3
- package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_risk_chain_view.sysml +3 -3
- package/examples/gpca-pump/model/catalog/viewpoints/software/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/document_sdd_view.sysml +4 -4
- package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/software_software_architecture_view.sysml +5 -5
- package/examples/gpca-pump/model/catalog/viewpoints/usability/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/usability/views}/document_usability_view.sysml +8 -6
- package/examples/gpca-pump/model/catalog/viewpoints/verification/viewpoint.sysml +8 -0
- package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/document_vv_view.sysml +7 -5
- package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/verification_verification_coverage_view.sysml +3 -3
- package/examples/ivd-laboratory-system/model/catalog/project.sysml +24 -0
- package/examples/ivd-laboratory-system/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/ivd-laboratory-system/model/{viewpoints → catalog/viewpoints/unassigned/views}/ivd_laboratory_system_overview.sysml +1 -1
- package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +4 -2
- package/examples/manual-surgical-instrument/model/catalog/project.sysml +24 -0
- package/examples/manual-surgical-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/manual-surgical-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/manual_surgical_instrument_overview.sysml +1 -1
- package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -2
- package/examples/multidimensional-layers/model/catalog/project.sysml +24 -0
- package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/multidimensional-layers/model/{viewpoints → catalog/viewpoints/unassigned/views}/multidimensional_layers_overview.sysml +1 -1
- package/examples/nested-architecture-dsm/README.md +49 -0
- package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +179 -0
- package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +165 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +53 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +89 -0
- package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +113 -0
- package/examples/nested-architecture-dsm/model/catalog/project.sysml +28 -0
- package/examples/nested-architecture-dsm/model/catalog/traces.sysml +48 -0
- package/examples/reusable-instrument/model/catalog/project.sysml +24 -0
- package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +11 -8
- package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/reusable-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/reusable_instrument_overview.sysml +1 -1
- package/examples/ros-mobile-robot/README.md +40 -0
- package/examples/ros-mobile-robot/model/catalog/project.sysml +33 -0
- package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +296 -0
- package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +7 -0
- package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/views/ros_mobile_robot_overview.sysml +13 -0
- package/examples/software-only-medical-device/model/catalog/project.sysml +28 -0
- package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +11 -5
- package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/software-only-medical-device/model/{viewpoints → catalog/viewpoints/unassigned/views}/software_only_medical_device_overview.sysml +1 -1
- package/examples/surgical-closure-workflow/model/catalog/project.sysml +24 -0
- package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +57 -57
- package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/surgical-closure-workflow/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_closure_workflow_overview.sysml +1 -1
- package/examples/surgical-robot/model/catalog/project.sysml +24 -0
- package/examples/surgical-robot/model/catalog/surgical_robot.sysml +6 -4
- package/examples/surgical-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/surgical-robot/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_robot_overview.sysml +1 -1
- package/examples/sysml-diagram-samples/README.md +7 -0
- package/examples/sysml-diagram-samples/dhf/documents/DOC-HAR-001.md +11 -0
- package/examples/sysml-diagram-samples/memo.package.yaml +11 -5
- package/examples/sysml-diagram-samples/model/catalog/project.sysml +33 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/action_flow_view.sysml +23 -20
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/context_view.sysml +11 -11
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.viewlayout +47 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +143 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +87 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.viewlayout +94 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +109 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.viewlayout +13 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/requirements_view.sysml +6 -7
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +33 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +80 -0
- package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +48 -0
- package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/use_case_view.sysml +15 -9
- package/examples/sysml-diagram-samples/model/sysml_v2_activity_example.sysml +93 -0
- package/examples/temperature-alarm/model/catalog/project.sysml +24 -0
- package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +29 -21
- package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
- package/examples/temperature-alarm/model/{viewpoints → catalog/viewpoints/unassigned/views}/temperature_alarm_overview.sysml +1 -1
- package/examples/ui-screen-regions/README.md +117 -0
- package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +84 -0
- package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +212 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +61 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/drugSelectorRegion/drug-selector-expanded-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/mainScreenLayout/main-screen-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/settingsScreenLayout/settings-screen-2.4.1.png +0 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +51 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +27 -0
- package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +27 -0
- package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +59 -0
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +25 -0
- package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +178 -0
- package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +93 -0
- package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +75 -0
- package/examples/ui-screen-regions/model/catalog/project.sysml +45 -0
- package/examples/ui-screen-regions/model/catalog/relationships.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/traces.sysml +179 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +62 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/viewpoint.sysml +8 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +57 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +52 -0
- package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +54 -0
- package/extensions/LICENSES/MIT.txt +19 -0
- package/extensions/README.md +94 -0
- package/extensions/aadl/memo.package.yaml +18 -0
- package/extensions/aadl/src/aadl_extension.sysml +6 -0
- package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +147 -0
- package/extensions/aadl/src/methodology/aadl_methodology.sysml +17 -0
- package/extensions/aadl/src/runtime/memo_aadl_runtime.sysml +56 -0
- package/extensions/clinical/memo.package.yaml +18 -0
- package/extensions/clinical/src/methodology/clinical_methodology.sysml +22 -0
- package/extensions/cloud/memo.package.yaml +18 -0
- package/extensions/cloud/src/cloud_extension.sysml +44 -0
- package/extensions/cloud/src/methodology/cloud_methodology.sysml +17 -0
- package/extensions/container/memo.package.yaml +18 -0
- package/extensions/container/src/container_extension.sysml +37 -0
- package/extensions/container/src/methodology/container_methodology.sysml +17 -0
- package/extensions/messaging/memo.package.yaml +18 -0
- package/extensions/messaging/src/messaging_extension.sysml +64 -0
- package/extensions/messaging/src/methodology/messaging_methodology.sysml +17 -0
- package/extensions/ros/memo.package.yaml +18 -0
- package/extensions/ros/src/methodology/ros_methodology.sysml +25 -0
- package/extensions/ros/src/ros_extension.sysml +200 -0
- package/extensions/template/memo.package.yaml +17 -0
- package/extensions/template/src/extension.sysml +37 -0
- package/memo.manifest.yaml +15 -2
- package/methodologies/default/memo.package.yaml +19 -9
- package/methodologies/gpca/memo.package.yaml +18 -9
- package/ontology/memo.package.yaml +23 -8
- package/package.json +6 -6
- package/profile/memo.package.yaml +18 -9
- package/src/architecture/decisions/memo_decisions.sysml +28 -0
- package/src/architecture/functional/behavior/memo_behavior.sysml +50 -22
- package/src/architecture/functional/constraints/memo_constraints.sysml +3 -2
- package/src/architecture/functional/functions/memo_functions.sysml +93 -43
- package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +46 -24
- package/src/architecture/implementation/software/structure/memo_software_structure.sysml +52 -12
- package/src/architecture/implementation/ui/memo_ui.sysml +276 -53
- package/src/architecture/logical/interfaces/memo_interfaces.sysml +64 -13
- package/src/architecture/logical/structure/memo_logical_structure.sysml +92 -35
- package/src/architecture/operational/activities/memo_activities.sysml +10 -4
- package/src/architecture/operational/context/actors/memo_actors.sysml +5 -8
- package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +13 -30
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +42 -16
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +57 -23
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +35 -26
- package/src/architecture/operational/workflows/memo_workflows.sysml +28 -15
- package/src/architecture/realization/deployment/memo_deployment.sysml +111 -16
- package/src/architecture/realization/physical/memo_physical_architecture.sysml +27 -2
- package/src/artifacts/configuration_management/memo_configuration_management.sysml +35 -0
- package/src/artifacts/core/memo_controlled_artifacts.sysml +35 -0
- package/src/artifacts/documents/risk_management/memo_risk_management.sysml +12 -0
- package/src/artifacts/standards/cfr_21_820.sysml +116 -0
- package/src/artifacts/standards/fda_cybersecurity_2023.sysml +80 -0
- package/src/artifacts/standards/iec_60601_1.sysml +149 -0
- package/src/artifacts/standards/iec_60601_1_2.sysml +56 -0
- package/src/artifacts/standards/iec_60812.sysml +51 -0
- package/src/artifacts/standards/iec_62304.sysml +210 -0
- package/src/artifacts/standards/iec_62366_1.sysml +113 -0
- package/src/artifacts/standards/iec_81001_5_1.sysml +84 -0
- package/src/artifacts/standards/iso_13485.sysml +113 -0
- package/src/artifacts/standards/iso_14971.sysml +94 -0
- package/src/artifacts/standards/iso_iec_ieee_42010.sysml +42 -0
- package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml +132 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-input.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-output.md +5 -5
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-review.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-validation.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-verification.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/dhf-index.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/transfer-plan.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/user-needs.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-plan.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-report.md +4 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/incident-response.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/postmarket-surveillance.md +3 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/security-arch.md +2 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/threat-model.md +4 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/vuln-assessment.md +4 -3
- package/src/artifacts/templates/dhf/iec-60601/hrs.md +170 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/detailed-design.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/integration-test.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sad.md +6 -5
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sbom.md +3 -2
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sdp.md +5 -4
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/soup.md +4 -2
- package/src/artifacts/templates/dhf/iec-62304/srs.md +172 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sw-traceability.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/system-test.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/summative-eval.md +1 -1
- package/src/artifacts/templates/dhf/iec-62366/task-analysis.md +93 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ue-plan.md +1 -1
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/urra.md +3 -3
- package/src/artifacts/templates/dhf/iso-14971/fmea.md +116 -0
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/har.md +3 -3
- package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmp.md +2 -2
- package/src/artifacts/templates/dhf/system/sad.md +173 -0
- package/src/artifacts/templates/dhf/system/standards-checklist.md +87 -0
- package/src/artifacts/templates/dhf/system/standards-traceability.md +125 -0
- package/src/artifacts/templates/dhf/system/syrs.md +128 -0
- package/src/assurance/cybersecurity/memo_cybersecurity.sysml +39 -20
- package/src/assurance/human_factors/memo_human_factors.sysml +29 -22
- package/src/assurance/requirements/memo_requirements.sysml +5 -2
- package/src/assurance/requirements/needs/memo_needs.sysml +1 -1
- package/src/assurance/safety_risk/analysis/memo_fmea.sysml +118 -13
- package/src/assurance/safety_risk/memo_risk.sysml +78 -7
- package/src/assurance/safety_risk/postmarket_surveillance/memo_postmarket_surveillance.sysml +27 -0
- package/src/assurance/verification_validation/clinical_evaluation/memo_clinical_evaluation.sysml +11 -0
- package/src/assurance/verification_validation/memo_assurance.sysml +17 -21
- package/src/core/annotations/memo_annotations.sysml +96 -0
- package/src/core/common/memo_common.sysml +140 -18
- package/src/core/consistency_rules/consistency_rules.sysml +7 -0
- package/src/core/dimensions/dimensions.sysml +17 -1
- package/src/core/enumerations/memo_enumerations.sysml +101 -20
- package/src/core/methodology_scope/methodology_scope.sysml +7 -15
- package/src/core/relationships/memo_relationships.sysml +199 -194
- package/src/memo_namespaces.sysml +127 -67
- package/src/methodology/core/memo_core.sysml +69 -2
- package/src/methodology/profiles/memo_profiles.sysml +31 -41
- package/src/methodology/workflow/memo_workflow.sysml +7 -2
- package/src/rules/closure/closure_rules.sysml +104 -31
- package/src/rules/coverage/coverage_rules.sysml +4 -256
- package/src/rules/crosslayer/cross_layer_rules.sysml +6 -15
- package/src/rules/lifecycle/lifecycle_rules.sysml +4 -39
- package/src/rules/ontology/ontology_invariants.sysml +243 -74
- package/src/rules/quantitative/quantitative_rules.sysml +8 -8
- package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +10 -3
- package/src/viewpoints/clinical/clinical_viewpoint.sysml +4 -2
- package/src/viewpoints/clinical/{clinical_evidence_view → views/clinical_evidence_view}/clinical_evidence_view.sysml +2 -2
- package/src/viewpoints/context/context_viewpoint.sysml +4 -2
- package/src/viewpoints/context/{system_context_view → views/system_context_view}/system_context_view.sysml +2 -2
- package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +4 -2
- package/src/viewpoints/cybersecurity/{cybersecurity_assessment_view → views/cybersecurity_assessment_view}/cybersecurity_assessment_view.sysml +2 -2
- package/src/viewpoints/cybersecurity/{threat_model_view → views/threat_model_view}/threat_model_view.sysml +2 -2
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +5 -0
- package/src/viewpoints/functional/functional_viewpoint.sysml +4 -2
- package/src/viewpoints/functional/{function_allocation_view → views/function_allocation_view}/function_allocation_view.sysml +3 -3
- package/src/viewpoints/functional/{system_functional_tree_view → views/system_functional_tree_view}/system_functional_tree_view.sysml +3 -3
- package/src/viewpoints/logical/logical_viewpoint.sysml +3 -1
- package/src/viewpoints/logical/{logical_architecture_view → views/logical_architecture_view}/logical_architecture_view.sysml +2 -2
- package/src/viewpoints/operational/operational_viewpoint.sysml +4 -2
- package/src/viewpoints/operational/{use_case_view → views/use_case_view}/use_case_view.sysml +3 -3
- package/src/viewpoints/physical/physical_viewpoint.sysml +3 -1
- package/src/viewpoints/physical/{network_topology_view → views/network_topology_view}/network_topology_view.sysml +2 -2
- package/src/viewpoints/physical/{physical_bom_view → views/physical_bom_view}/physical_bom_view.sysml +2 -2
- package/src/viewpoints/rendering/memo_rendering.sysml +354 -0
- package/src/viewpoints/requirements/requirements_viewpoint.sysml +3 -1
- package/src/viewpoints/requirements/{requirements_traceability_view → views/requirements_traceability_view}/requirements_traceability_view.sysml +2 -2
- package/src/viewpoints/risk/risk_viewpoint.sysml +3 -1
- package/src/viewpoints/risk/{risk_chain_view → views/risk_chain_view}/risk_chain_view.sysml +2 -2
- package/src/viewpoints/software/software_viewpoint.sysml +3 -1
- package/src/viewpoints/software/{software_architecture_view → views/software_architecture_view}/software_architecture_view.sysml +2 -2
- package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +28 -0
- package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +23 -0
- package/src/viewpoints/usability/usability_viewpoint.sysml +3 -1
- package/src/viewpoints/usability/{usability_engineering_view → views/usability_engineering_view}/usability_engineering_view.sysml +2 -2
- package/src/viewpoints/verification/verification_viewpoint.sysml +4 -2
- package/src/viewpoints/verification/{verification_coverage_view → views/verification_coverage_view}/verification_coverage_view.sysml +3 -3
- package/templates/connected-device/memo.package.yaml +11 -5
- package/templates/connected-device/model/catalog/project.sysml +28 -0
- package/templates/connected-device/syside.toml +1 -1
- package/templates/default/memo.package.yaml +11 -5
- package/templates/default/model/catalog/project.sysml +28 -0
- package/templates/default/syside.toml +1 -1
- package/templates/infusion-pump/memo.package.yaml +11 -5
- package/templates/infusion-pump/model/catalog/project.sysml +28 -0
- package/templates/infusion-pump/syside.toml +1 -1
- package/templates/monitoring-device/memo.package.yaml +11 -5
- package/templates/monitoring-device/model/catalog/project.sysml +28 -0
- package/templates/monitoring-device/syside.toml +1 -1
- package/templates/samd/memo.package.yaml +11 -5
- package/templates/samd/model/catalog/project.sysml +28 -0
- package/templates/samd/syside.toml +1 -1
- package/examples/connected-patient-monitor/model/connected_patient_monitor.sysml +0 -3
- package/examples/embedded-infusion-pump/model/embedded_infusion_pump.sysml +0 -3
- package/examples/extensions/README.md +0 -16
- package/examples/extensions/clinical/memo.package.yaml +0 -9
- package/examples/extensions/clinical/src/methodology/clinical_methodology.sysml +0 -14
- package/examples/extensions/template/memo.package.yaml +0 -9
- package/examples/extensions/template/src/extension.sysml +0 -15
- package/examples/functional-logical-physical/model/functional_logical_physical.sysml +0 -3
- package/examples/gpca-pump/memo.config.yaml +0 -9
- package/examples/gpca-pump/methodology/gpca_scope.sysml +0 -25
- package/examples/ivd-laboratory-system/model/ivd_laboratory_system.sysml +0 -3
- package/examples/manual-surgical-instrument/model/manual_surgical_instrument.sysml +0 -3
- package/examples/multidimensional-layers/model/multidimensional_layers.sysml +0 -4
- package/examples/reusable-instrument/model/reusable_instrument.sysml +0 -4
- package/examples/software-only-medical-device/model/software_only_medical_device.sysml +0 -4
- package/examples/surgical-closure-workflow/model/surgical_closure_workflow.sysml +0 -4
- package/examples/surgical-robot/model/surgical_robot.sysml +0 -4
- package/examples/sysml-diagram-samples/model/samples/functional_flow_view.sysml +0 -164
- package/examples/sysml-diagram-samples/model/samples/interconnection_view.sysml +0 -94
- package/examples/sysml-diagram-samples/model/samples/operational_behaviour_view.sysml +0 -135
- package/examples/sysml-diagram-samples/model/samples/state_transition_view.sysml +0 -109
- package/examples/sysml-diagram-samples/model/samples/tree_view.sysml +0 -56
- package/examples/temperature-alarm/model/temperature_alarm.sysml +0 -4
- package/ontology/memo.rendering.yaml +0 -84
- package/src/compliance/artifacts/memo_artifacts.sysml +0 -12
- package/src/compliance/change/memo_change.sysml +0 -17
- package/src/compliance/dhf-templates/iec-62304/srs.md +0 -138
- package/src/compliance/dhf-templates/iec-62366/task-analysis.md +0 -57
- package/src/compliance/dhf-templates/iso-14971/fmea.md +0 -93
- package/src/compliance/document_views/memo_document_views.sysml +0 -7
- package/src/compliance/iso14971/risk_management_file.sysml +0 -16
- package/src/compliance/postmarket/memo_postmarket.sysml +0 -16
- /package/{examples/extensions → extensions}/clinical/src/clinical_extension.sysml +0 -0
- /package/{examples/extensions → extensions}/clinical/src/procedures/memo_clinical_procedures.sysml +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/change-record.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/change-control.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/formative-eval.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ui-spec.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/use-spec.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/fta.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-benefit.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-matrix.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmr.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/approval-block.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/document-control-header.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/references-section.md +0 -0
- /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/revision-history-table.md +0 -0
- /package/templates/connected-device/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/connected-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/connected-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/default/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/default/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/default/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/infusion-pump/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/infusion-pump/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/infusion-pump/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/monitoring-device/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/monitoring-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/monitoring-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
- /package/templates/samd/{src → model/catalog}/architecture/system.sysml +0 -0
- /package/templates/samd/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
- /package/templates/samd/{src → model/catalog}/assurance/requirements.sysml +0 -0
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attribute :>> statement = "The system shall always be in only one of the following modes: OFF (default mode), IDLE, PAUSED, BASAL, SQUARE BOLUS or PATIENT BOLUS.";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.1 (REQ 1)";
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attribute :>> statement = "If there are mode transitions without change in flow rates between the two modes, the system shall transition within Max_Mode_Change_Duration_const.";
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attribute :>> statement = "If there are mode transitions with change in flow rates between the two modes, the system shall change from the current mode flow rate to the new mode flow rate at a rate not more than Max_Rateof_Flow_Change_const or within Max_Mode_Change_Duration_const, whichever achieves the new desired flow rate the quickest.";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.1 (REQ 3)";
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attribute :>> statement = "The system shall transition from OFF mode to ON > IDLE mode when System_start_prog is commanded. At this transition, the variables in App. A.4 shall be set to their default values.";
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attribute :>> statement = "While in ON mode, when System_stop_prog is commanded, the system shall stop infusion, cancel all notifications and transition to OFF mode.";
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attribute :>> acceptanceCriteria = "First Infusion_initiate_prog displays saved values; therapy starts only after a second Infusion_initiate_prog.";
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attribute :>> statement = "While in ON mode, the system shall allow visual and audio notification as described in §4.3.";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 11)";
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attribute :>> statement = "While in ON mode, when the second Infusion_initiate_prog is commanded as per REQ 9 and Inhibited_Infusion_macro = FALSE, the system shall reset Actual_Infusion_Duration_macro = 0 and Actual_Volume_Infused_macro = 0 and shall transition to ON > THERAPY > ACTIVE > BASAL mode.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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+
attribute :>> status = ElementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Actual_Infusion_Duration_macro = 0 AND Actual_Volume_Infused_macro = 0 AND mode = ON > THERAPY > ACTIVE > BASAL";
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attribute :>> subjectDescription = "ON mode transitions";
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532
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.2 (REQ 12)";
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@@ -537,7 +538,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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537
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attribute :>> statement = "While in ON mode, when the second Infusion_initiate_prog is commanded as per REQ 9 and Inhibited_Infusion_macro = TRUE, the system shall reset Actual_Infusion_Duration_macro = 0 and Actual_Volume_Infused_macro = 0, shall transition to ON > THERAPY > PAUSED mode and perform actions as described in REQ 59 for 'Infusion Inhibited'.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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-
attribute :>>
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+
attribute :>> status = ElementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro = TRUE => mode = ON > THERAPY > PAUSED and 'Infusion Inhibited' actions taken";
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attribute :>> subjectDescription = "ON mode transitions";
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543
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.2 (REQ 13)";
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@@ -550,7 +551,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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550
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attribute :>> statement = "While in IDLE mode, the system shall not deliver any drug.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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-
attribute :>>
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+
attribute :>> status = ElementStatusKind::approved;
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attribute :>> acceptanceCriteria = "FlowRate_output = 0";
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attribute :>> subjectDescription = "ON > IDLE mode";
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556
557
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.4.1 (REQ 14)";
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@@ -561,7 +562,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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561
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attribute :>> statement = "While in IDLE mode for more than Max_IDLE_Duration_const, the system shall take actions as defined in REQ 59 for 'IDLE Time'.";
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563
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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-
attribute :>>
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+
attribute :>> status = ElementStatusKind::approved;
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attribute :>> acceptanceCriteria = "time in IDLE > Max_IDLE_Duration_const => 'IDLE Time' actions taken";
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566
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attribute :>> subjectDescription = "ON > IDLE mode";
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567
568
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.4.1 (REQ 15)";
|
|
@@ -574,7 +575,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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574
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|
attribute :>> statement = "While in THERAPY mode, the system shall deliver the drug as per the respective sub-mode's programmed flow rate, FlowRate_Mode_macro, within a tolerance of Tolerance_Max_const.";
|
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575
576
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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577
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attribute :>> concernKind = ConcernKind::safety;
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-
attribute :>>
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+
attribute :>> status = ElementStatusKind::approved;
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578
579
|
attribute :>> acceptanceCriteria = "FlowRate_output < FlowRate_Mode_macro + Tolerance_Max_const";
|
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579
580
|
attribute :>> subjectDescription = "ON > THERAPY mode";
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580
581
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 16)";
|
|
@@ -585,7 +586,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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585
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attribute :>> statement = "While in THERAPY mode, the system shall take actions as defined in REQ 59 for 'Under Infusion FlowRate' if the output flow rate falls below the mode flow rate beyond the tolerance windows.";
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586
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|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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-
attribute :>>
|
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+
attribute :>> status = ElementStatusKind::approved;
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590
|
attribute :>> acceptanceCriteria = "FlowRate_output < FlowRate_Mode_macro - Tolerance_Min_const for more than Max_Duration_UnderInfusion_const OR FlowRate_output < FlowRate_Mode_macro - Tolerance_Max_const OR FlowRate_output < FlowRate_lo_hd";
|
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590
591
|
attribute :>> subjectDescription = "ON > THERAPY mode";
|
|
591
592
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 17)";
|
|
@@ -596,7 +597,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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|
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596
597
|
attribute :>> statement = "While in THERAPY mode, when the current volume of drug in the reservoir is less than Low_Reservoir_const, the system shall perform the actions defined in REQ 59 for 'Low Reservoir'.";
|
|
597
598
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
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598
599
|
attribute :>> concernKind = ConcernKind::safety;
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599
|
-
attribute :>>
|
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600
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+
attribute :>> status = ElementStatusKind::approved;
|
|
600
601
|
attribute :>> acceptanceCriteria = "reservoir volume < Low_Reservoir_const => 'Low Reservoir' actions taken";
|
|
601
602
|
attribute :>> subjectDescription = "ON > THERAPY mode";
|
|
602
603
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 18)";
|
|
@@ -607,7 +608,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
607
608
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform the actions described in REQ 59 for 'Over Infusion FlowRate' if the output flow rate exceeds the mode flow rate beyond the tolerance windows.";
|
|
608
609
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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|
609
610
|
attribute :>> concernKind = ConcernKind::safety;
|
|
610
|
-
attribute :>>
|
|
611
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
611
612
|
attribute :>> acceptanceCriteria = "FlowRate_output > FlowRate_Mode_macro + Tolerance_Min_const for more than Max_Duration_OverInfusion_const OR FlowRate_output > FlowRate_Mode_macro + Tolerance_Max_const OR FlowRate_output > FlowRate_hi_hd";
|
|
612
613
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
613
614
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 19)";
|
|
@@ -618,7 +619,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
618
619
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and take the actions described in REQ 59 for 'Over Infusion VTBI' if the actual volume infused exceeds the drug-database maximum VTBI.";
|
|
619
620
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
620
621
|
attribute :>> concernKind = ConcernKind::safety;
|
|
621
|
-
attribute :>>
|
|
622
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
622
623
|
attribute :>> acceptanceCriteria = "Actual_Volume_Infused_macro > VTBI_hi_hd";
|
|
623
624
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
624
625
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 20)";
|
|
@@ -629,7 +630,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
629
630
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform the actions defined in REQ 59 for 'Air embolism' if an air bubble of a volume larger than Single_AirBubble_Volume_const flows through the hose, or the sum of volume of all air bubbles flowing through the hose exceeds Cumulative_AirBubble_Volume_const for the same time interval defined for Cumulative_AirBubble_Volume_const.";
|
|
630
631
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
631
632
|
attribute :>> concernKind = ConcernKind::safety;
|
|
632
|
-
attribute :>>
|
|
633
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
633
634
|
attribute :>> acceptanceCriteria = "single bubble volume > Single_AirBubble_Volume_const OR cumulative bubble volume > Cumulative_AirBubble_Volume_const";
|
|
634
635
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
635
636
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 21)";
|
|
@@ -640,7 +641,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
640
641
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform actions defined in REQ 59 for 'Reverse Delivery' if there is continuous reverse delivery for more than Rev_Delivery_Continuous_Duration_const, or the cumulative time of all reverse delivery episodes exceeds Rev_Delivery_Cumulative_Duration_const.";
|
|
641
642
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
642
643
|
attribute :>> concernKind = ConcernKind::safety;
|
|
643
|
-
attribute :>>
|
|
644
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
644
645
|
attribute :>> acceptanceCriteria = "continuous reverse delivery > Rev_Delivery_Continuous_Duration_const OR cumulative reverse delivery > Rev_Delivery_Cumulative_Duration_const";
|
|
645
646
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
646
647
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 22)";
|
|
@@ -651,7 +652,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
651
652
|
attribute :>> statement = "While in THERAPY mode and if the volume of drug in the reservoir is less than Empty_Reservoir_const, the system shall transition to PAUSED mode and perform actions as listed in REQ 59 for 'Empty Reservoir'.";
|
|
652
653
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
653
654
|
attribute :>> concernKind = ConcernKind::safety;
|
|
654
|
-
attribute :>>
|
|
655
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
655
656
|
attribute :>> acceptanceCriteria = "reservoir volume < Empty_Reservoir_const => mode = PAUSED and 'Empty Reservoir' actions taken";
|
|
656
657
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
657
658
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 23)";
|
|
@@ -664,7 +665,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
664
665
|
attribute :>> statement = "While in ACTIVE mode, the system shall schedule to start a SQUARE BOLUS every Interval_sbolus_prog and end after Duration_sbolus_prog during the Duration_total_prog.";
|
|
665
666
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
666
667
|
attribute :>> concernKind = ConcernKind::safety;
|
|
667
|
-
attribute :>>
|
|
668
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
668
669
|
attribute :>> acceptanceCriteria = "Square boluses are auto-scheduled by the system every Interval_sbolus_prog for Duration_sbolus_prog; no external trigger is required.";
|
|
669
670
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
670
671
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 24)";
|
|
@@ -675,7 +676,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
675
676
|
attribute :>> statement = "While in ACTIVE mode, when BolusRequest_prog, the system shall ignore the patient bolus request (BolusRequest_prog = FALSE) if: (1) Inhibited_Infusion_macro = TRUE, OR (2) Inhibited_PatientBolus_macro = TRUE, OR (3) the interval between the most recent PATIENT BOLUS mode end time and the current BolusRequest_prog time violates LockOutPeriod_pbolus_prog, OR (4) the total number of delivered patient boluses for the current prescription violates the programmed maximum number of patient boluses, OR (5) the system is currently in PATIENT BOLUS mode.";
|
|
676
677
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
677
678
|
attribute :>> concernKind = ConcernKind::safety;
|
|
678
|
-
attribute :>>
|
|
679
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
679
680
|
attribute :>> acceptanceCriteria = "Source formal conditions: (3) (BolusRequest_prog time - most recent PATIENT BOLUS end time) > LockOutPeriod_pbolus_prog; (4) sum of occurrences of all PATIENT BOLUS modes > NumberMax_pbolus_prog (source prose and formal expressions are inconsistent; transcribed as written).";
|
|
680
681
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
681
682
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 25)";
|
|
@@ -686,7 +687,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
686
687
|
attribute :>> statement = "While in ACTIVE mode, the system shall perform the actions described in REQ 59 for 'Frequent Bolus Requests' if the condition described in REQ 25.3 or REQ 25.5 occurs.";
|
|
687
688
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
688
689
|
attribute :>> concernKind = ConcernKind::safety;
|
|
689
|
-
attribute :>>
|
|
690
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
690
691
|
attribute :>> acceptanceCriteria = "REQ 25 condition 3 or 5 => 'Frequent Bolus Requests' actions taken";
|
|
691
692
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
692
693
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 26)";
|
|
@@ -697,7 +698,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
697
698
|
attribute :>> statement = "While in ACTIVE mode, the system shall perform the actions described in REQ 59 for 'Bolus Exceeded' if the condition described in REQ 25.4 occurs.";
|
|
698
699
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
699
700
|
attribute :>> concernKind = ConcernKind::safety;
|
|
700
|
-
attribute :>>
|
|
701
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
701
702
|
attribute :>> acceptanceCriteria = "REQ 25 condition 4 => 'Bolus Exceeded' actions taken";
|
|
702
703
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
703
704
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 27)";
|
|
@@ -708,7 +709,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
708
709
|
attribute :>> statement = "While in ACTIVE mode, the system shall transition to IDLE and perform actions described in REQ 59 for 'Infusion Complete' if the actual duration of infusion is greater than or equal to the programmed prescription total duration, or the total volume infused is greater than or equal to the programmed prescription maximum VTBI.";
|
|
709
710
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
710
711
|
attribute :>> concernKind = ConcernKind::safety;
|
|
711
|
-
attribute :>>
|
|
712
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
712
713
|
attribute :>> acceptanceCriteria = "Actual_Infusion_Duration_macro >= Duration_total_prog OR Actual_Volume_Infused_macro >= VTBI_total_prog";
|
|
713
714
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
714
715
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 28)";
|
|
@@ -719,7 +720,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
719
720
|
attribute :>> statement = "While in ACTIVE mode, when Infusion_inhibit_prog, the system shall transition to PAUSED mode and perform actions described in REQ 59 for 'Infusion Manually Inhibited'.";
|
|
720
721
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
721
722
|
attribute :>> concernKind = ConcernKind::safety;
|
|
722
|
-
attribute :>>
|
|
723
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
723
724
|
attribute :>> acceptanceCriteria = "Infusion_inhibit_prog => mode = PAUSED and 'Infusion Manually Inhibited' actions taken";
|
|
724
725
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
725
726
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 29)";
|
|
@@ -730,7 +731,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
730
731
|
attribute :>> statement = "While in ACTIVE mode, when Inhibited_Infusion_macro = TRUE, Inhibited_Bolus_macro = TRUE and Inhibited_PatientBolus_macro = TRUE, the system shall transition to PAUSED mode.";
|
|
731
732
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
732
733
|
attribute :>> concernKind = ConcernKind::safety;
|
|
733
|
-
attribute :>>
|
|
734
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
734
735
|
attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro AND Inhibited_Bolus_macro AND Inhibited_PatientBolus_macro => mode = PAUSED";
|
|
735
736
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
736
737
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 30)";
|
|
@@ -741,7 +742,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
741
742
|
attribute :>> statement = "While in BASAL mode, when SQUARE BOLUS is initiated as described in REQ 24, the system shall transition to SQUARE BOLUS mode if (1) Inhibited_Bolus_macro = FALSE, AND (2) Inhibited_Infusion_macro = FALSE, AND (3) either there is no BolusRequest_prog, or there is a BolusRequest_prog and at least one of the conditions listed in REQ 25 is true.";
|
|
742
743
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
743
744
|
attribute :>> concernKind = ConcernKind::safety;
|
|
744
|
-
attribute :>>
|
|
745
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
745
746
|
attribute :>> acceptanceCriteria = "NOT Inhibited_Bolus_macro AND NOT Inhibited_Infusion_macro AND (no BolusRequest_prog OR a REQ 25 ignore condition holds)";
|
|
746
747
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
747
748
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 31)";
|
|
@@ -752,7 +753,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
752
753
|
attribute :>> statement = "While in BASAL mode, the system shall transition to PATIENT BOLUS mode when BolusRequest_prog and none of the conditions listed in REQ 25 are true.";
|
|
753
754
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
754
755
|
attribute :>> concernKind = ConcernKind::safety;
|
|
755
|
-
attribute :>>
|
|
756
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
756
757
|
attribute :>> acceptanceCriteria = "BolusRequest_prog AND no REQ 25 ignore condition holds => mode = PATIENT BOLUS";
|
|
757
758
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
758
759
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 32)";
|
|
@@ -763,7 +764,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
763
764
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall transition to PATIENT BOLUS mode if BolusRequest_prog and none of the conditions listed in REQ 25 are true.";
|
|
764
765
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
765
766
|
attribute :>> concernKind = ConcernKind::safety;
|
|
766
|
-
attribute :>>
|
|
767
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
767
768
|
attribute :>> acceptanceCriteria = "BolusRequest_prog AND no REQ 25 ignore condition holds => mode = PATIENT BOLUS";
|
|
768
769
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
769
770
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 33)";
|
|
@@ -774,7 +775,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
774
775
|
attribute :>> statement = "While in SQUARE BOLUS mode, if Inhibited_Bolus_macro = TRUE or the SQUARE BOLUS is scheduled to end (as described in REQ 24), the system shall transition to BASAL mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) there is no BolusRequest_prog, or BolusRequest_prog and at least one of the conditions listed in REQ 25 is true.";
|
|
775
776
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
776
777
|
attribute :>> concernKind = ConcernKind::safety;
|
|
777
|
-
attribute :>>
|
|
778
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
778
779
|
attribute :>> acceptanceCriteria = "(Inhibited_Bolus_macro OR scheduled end) AND NOT Inhibited_Infusion_macro AND (no BolusRequest_prog OR a REQ 25 ignore condition holds) => mode = BASAL";
|
|
779
780
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
780
781
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 34)";
|
|
@@ -785,7 +786,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
785
786
|
attribute :>> statement = "While in PATIENT BOLUS mode, when Inhibited_PatientBolus_macro = TRUE or the total duration in the current PATIENT BOLUS mode is greater than or equal to Duration_pbolus_prog, the system shall stop the PATIENT BOLUS delivery and transition to BASAL mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) no SQUARE BOLUS is scheduled to be in progress at the time of transition, OR (3) a SQUARE BOLUS is scheduled to be in progress at the time of transition and Inhibited_Bolus_macro = TRUE.";
|
|
786
787
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
787
788
|
attribute :>> concernKind = ConcernKind::safety;
|
|
788
|
-
attribute :>>
|
|
789
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
789
790
|
attribute :>> acceptanceCriteria = "(Inhibited_PatientBolus_macro OR patient-bolus duration >= Duration_pbolus_prog) AND NOT Inhibited_Infusion_macro AND (no square bolus scheduled OR (square bolus scheduled AND Inhibited_Bolus_macro)) => mode = BASAL";
|
|
790
791
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
791
792
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 35)";
|
|
@@ -796,7 +797,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
796
797
|
attribute :>> statement = "While in PATIENT BOLUS mode, when Inhibited_PatientBolus_macro = TRUE or the total duration in the current PATIENT BOLUS mode is greater than or equal to Duration_pbolus_prog, the system shall stop the PATIENT BOLUS delivery and transition to SQUARE BOLUS mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) a SQUARE BOLUS is scheduled to be in progress at the time of transition, AND (3) Inhibited_Bolus_macro = FALSE.";
|
|
797
798
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
798
799
|
attribute :>> concernKind = ConcernKind::safety;
|
|
799
|
-
attribute :>>
|
|
800
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
800
801
|
attribute :>> acceptanceCriteria = "(Inhibited_PatientBolus_macro OR patient-bolus duration >= Duration_pbolus_prog) AND NOT Inhibited_Infusion_macro AND square bolus scheduled AND NOT Inhibited_Bolus_macro => mode = SQUARE BOLUS";
|
|
801
802
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
802
803
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 36)";
|
|
@@ -807,7 +808,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
807
808
|
attribute :>> statement = "While in BASAL mode, if Inhibited_Infusion_macro = TRUE, the system shall transition to PAUSE mode.";
|
|
808
809
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
809
810
|
attribute :>> concernKind = ConcernKind::safety;
|
|
810
|
-
attribute :>>
|
|
811
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
811
812
|
attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro => mode = PAUSED";
|
|
812
813
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
813
814
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 37)";
|
|
@@ -818,7 +819,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
818
819
|
attribute :>> statement = "While in PATIENT BOLUS mode, the system shall transition to PAUSE mode if Inhibited_PatientBolus_macro = TRUE and Inhibited_Infusion_macro = TRUE.";
|
|
819
820
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
820
821
|
attribute :>> concernKind = ConcernKind::safety;
|
|
821
|
-
attribute :>>
|
|
822
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
822
823
|
attribute :>> acceptanceCriteria = "Inhibited_PatientBolus_macro AND Inhibited_Infusion_macro => mode = PAUSED";
|
|
823
824
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
824
825
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 38)";
|
|
@@ -829,7 +830,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
829
830
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall transition to PAUSE mode if Inhibited_Bolus_macro = TRUE and Inhibited_Infusion_macro = TRUE.";
|
|
830
831
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
831
832
|
attribute :>> concernKind = ConcernKind::safety;
|
|
832
|
-
attribute :>>
|
|
833
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
833
834
|
attribute :>> acceptanceCriteria = "Inhibited_Bolus_macro AND Inhibited_Infusion_macro => mode = PAUSED";
|
|
834
835
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
835
836
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 39)";
|
|
@@ -842,7 +843,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
842
843
|
attribute :>> statement = "While in BASAL mode, the system shall deliver the drug at a flow rate FlowRate_basal_prog with a variation up to Tolerance_Max_const.";
|
|
843
844
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
844
845
|
attribute :>> concernKind = ConcernKind::safety;
|
|
845
|
-
attribute :>>
|
|
846
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
846
847
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_basal_prog";
|
|
847
848
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > BASAL mode";
|
|
848
849
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.7.1 (REQ 40)";
|
|
@@ -853,7 +854,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
853
854
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall deliver the drug at a flow rate FlowRate_sbolus_prog with a variation up to Tolerance_Max_const.";
|
|
854
855
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
855
856
|
attribute :>> concernKind = ConcernKind::safety;
|
|
856
|
-
attribute :>>
|
|
857
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
857
858
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_sbolus_prog";
|
|
858
859
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > SQUARE BOLUS mode";
|
|
859
860
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.8.1 (REQ 41)";
|
|
@@ -864,7 +865,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
864
865
|
attribute :>> statement = "While in PATIENT BOLUS mode, the system shall deliver the drug at a flow rate FlowRate_pbolus_prog with a variation up to Tolerance_Max_const.";
|
|
865
866
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
866
867
|
attribute :>> concernKind = ConcernKind::safety;
|
|
867
|
-
attribute :>>
|
|
868
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
868
869
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_pbolus_prog";
|
|
869
870
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > PATIENT BOLUS mode";
|
|
870
871
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.9.1 (REQ 42)";
|
|
@@ -877,7 +878,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
877
878
|
attribute :>> statement = "While in PAUSED mode, the system shall allow drug infusion at a flow rate FlowRate_kvo_hd with a variation up to Tolerance_Max_const, to keep the vein open when infusion is paused.";
|
|
878
879
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
879
880
|
attribute :>> concernKind = ConcernKind::safety;
|
|
880
|
-
attribute :>>
|
|
881
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
881
882
|
attribute :>> acceptanceCriteria = "FlowRate_Mode_macro = FlowRate_kvo_hd; FlowRate_output within Tolerance_Max_const of FlowRate_kvo_hd (KVO flow, not zero)";
|
|
882
883
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
883
884
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 43)";
|
|
@@ -888,7 +889,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
888
889
|
attribute :>> statement = "While in PAUSED mode for more than Max_PAUSED_Duration_const, the system shall perform actions as described in REQ 59 for 'PAUSED Time'.";
|
|
889
890
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
890
891
|
attribute :>> concernKind = ConcernKind::safety;
|
|
891
|
-
attribute :>>
|
|
892
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
892
893
|
attribute :>> acceptanceCriteria = "time in PAUSED > Max_PAUSED_Duration_const => 'PAUSED Time' actions taken";
|
|
893
894
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
894
895
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 44)";
|
|
@@ -899,7 +900,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
899
900
|
attribute :>> statement = "While in PAUSED mode, when Infusion_initiate_prog and Inhibited_Infusion_macro = TRUE, the system shall not perform any transition.";
|
|
900
901
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
901
902
|
attribute :>> concernKind = ConcernKind::safety;
|
|
902
|
-
attribute :>>
|
|
903
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
903
904
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog AND Inhibited_Infusion_macro => mode unchanged";
|
|
904
905
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
905
906
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 45)";
|
|
@@ -910,7 +911,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
910
911
|
attribute :>> statement = "While in PAUSED mode, when Infusion_initiate_prog and Inhibited_Infusion_macro = FALSE, the system shall transition to ON > THERAPY > ACTIVE > BASAL mode.";
|
|
911
912
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
912
913
|
attribute :>> concernKind = ConcernKind::safety;
|
|
913
|
-
attribute :>>
|
|
914
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
914
915
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog AND NOT Inhibited_Infusion_macro => mode = ON > THERAPY > ACTIVE > BASAL";
|
|
915
916
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode transitions";
|
|
916
917
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.2 (REQ 46)";
|
|
@@ -921,7 +922,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
921
922
|
attribute :>> statement = "While in PAUSED mode, when Infusion_inhibit_prog, the system shall transition to ON > IDLE mode and perform actions as described in REQ 59 for 'Infusion Stopped Manually'.";
|
|
922
923
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
923
924
|
attribute :>> concernKind = ConcernKind::safety;
|
|
924
|
-
attribute :>>
|
|
925
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
925
926
|
attribute :>> acceptanceCriteria = "Infusion_inhibit_prog => mode = ON > IDLE and 'Infusion Stopped Manually' actions taken";
|
|
926
927
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode transitions";
|
|
927
928
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.2 (REQ 47)";
|
|
@@ -934,7 +935,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
934
935
|
attribute :>> statement = "When in ON mode, if DataConfig_prog as described in REQ 8, the system shall display the saved prescription and reservoir initial volume values or their default values (if there are no saved prescription and reservoir initial volume values) in the order listed in §3.1.1 and §3.1.3.";
|
|
935
936
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
936
937
|
attribute :>> concernKind = ConcernKind::usability;
|
|
937
|
-
attribute :>>
|
|
938
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
938
939
|
attribute :>> acceptanceCriteria = "Displayed values equal saved values (or defaults) in the interface-specified order.";
|
|
939
940
|
attribute :>> subjectDescription = "Data configuration";
|
|
940
941
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 48)";
|
|
@@ -945,7 +946,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
945
946
|
attribute :>> statement = "When the prescription and reservoir initial volume data are displayed as described in REQ 48, the system shall allow editing the values one at a time in the order they are displayed.";
|
|
946
947
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
947
948
|
attribute :>> concernKind = ConcernKind::usability;
|
|
948
|
-
attribute :>>
|
|
949
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
949
950
|
attribute :>> acceptanceCriteria = "Exactly one value is editable at a time, in display order.";
|
|
950
951
|
attribute :>> subjectDescription = "Data configuration";
|
|
951
952
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 49)";
|
|
@@ -956,7 +957,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
956
957
|
attribute :>> statement = "When the values are modified as described in REQ 49, the system shall allow infusion initiation with the new set of values (Infusion_initiate_prog).";
|
|
957
958
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
958
959
|
attribute :>> concernKind = ConcernKind::usability;
|
|
959
|
-
attribute :>>
|
|
960
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
960
961
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog is accepted with the modified value set.";
|
|
961
962
|
attribute :>> subjectDescription = "Data configuration";
|
|
962
963
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 50)";
|
|
@@ -967,7 +968,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
967
968
|
attribute :>> statement = "When Infusion_initiate_prog as described in REQ 50, the system shall validate if all the values are consistent with the conditions specified in their respective Type Condition fields in §3.1.1 and §3.1.3.";
|
|
968
969
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
969
970
|
attribute :>> concernKind = ConcernKind::safety;
|
|
970
|
-
attribute :>>
|
|
971
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
971
972
|
attribute :>> acceptanceCriteria = "Every entered value satisfies its Type Condition constraints before saving.";
|
|
972
973
|
attribute :>> subjectDescription = "Data configuration";
|
|
973
974
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 51)";
|
|
@@ -978,7 +979,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
978
979
|
attribute :>> statement = "When the system is validating data as described in REQ 51, if the system is unable to access the drug database safe values, the system shall not save the values and perform actions as described in REQ 59 for 'Drug database not reachable'.";
|
|
979
980
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
980
981
|
attribute :>> concernKind = ConcernKind::safety;
|
|
981
|
-
attribute :>>
|
|
982
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
982
983
|
attribute :>> acceptanceCriteria = "Database unreachable => values not saved and 'Drug database not reachable' actions taken";
|
|
983
984
|
attribute :>> subjectDescription = "Data configuration";
|
|
984
985
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 52)";
|
|
@@ -989,7 +990,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
989
990
|
attribute :>> statement = "When the system is validating data as described in REQ 51, if any of the drug database safe values listed in §3.5 is not present, the system shall not perform the validation with respect to that missing field, perform actions as described in REQ 59 for 'Drug safe value not present' and continue validation.";
|
|
990
991
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
991
992
|
attribute :>> concernKind = ConcernKind::safety;
|
|
992
|
-
attribute :>>
|
|
993
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
993
994
|
attribute :>> acceptanceCriteria = "Missing safe value => that field's validation skipped, 'Drug safe value not present' actions taken, validation continues";
|
|
994
995
|
attribute :>> subjectDescription = "Data configuration";
|
|
995
996
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 53)";
|
|
@@ -1000,7 +1001,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1000
1001
|
attribute :>> statement = "If there are no notifications from REQ 51 and REQ 52, the system shall save the prescription values, clear all the notifications previously generated by REQ 51, REQ 52 and REQ 53 if any, and allow initiate infusion with the new values as described in REQ 9.";
|
|
1001
1002
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1002
1003
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1003
|
-
attribute :>>
|
|
1004
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1004
1005
|
attribute :>> acceptanceCriteria = "Validation clean => values saved, prior validation notifications cleared, initiation enabled per REQ 9.";
|
|
1005
1006
|
attribute :>> subjectDescription = "Data configuration";
|
|
1006
1007
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 54)";
|
|
@@ -1011,7 +1012,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1011
1012
|
attribute :>> statement = "If REQ 51 or REQ 52 had generated a notification, the system shall not save the prescription values, allow the clinician to edit the values of the fields as described in REQ 49 and then repeat steps from REQ 50 until all validations are passed as described in REQ 54.";
|
|
1012
1013
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1013
1014
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1014
|
-
attribute :>>
|
|
1015
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1015
1016
|
attribute :>> acceptanceCriteria = "Validation notification present => values not saved; edit-and-revalidate loop until clean.";
|
|
1016
1017
|
attribute :>> subjectDescription = "Data configuration";
|
|
1017
1018
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 55)";
|
|
@@ -1022,7 +1023,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1022
1023
|
attribute :>> statement = "While data configuration is in progress, the system shall remain in its current mode with the currently active prescription values, until infusion is initiated with the new prescription values as described in REQ 54.";
|
|
1023
1024
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1024
1025
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1025
|
-
attribute :>>
|
|
1026
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1026
1027
|
attribute :>> acceptanceCriteria = "Mode and active prescription are unchanged during configuration.";
|
|
1027
1028
|
attribute :>> subjectDescription = "Data configuration";
|
|
1028
1029
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 56)";
|
|
@@ -1033,7 +1034,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1033
1034
|
attribute :>> statement = "When the clinician has attempted to configure the data for more than Config_Warning_Duration_const continuously, the system shall perform actions as described in REQ 59 for 'Config Time'.";
|
|
1034
1035
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1035
1036
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1036
|
-
attribute :>>
|
|
1037
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1037
1038
|
attribute :>> acceptanceCriteria = "continuous configuration time > Config_Warning_Duration_const => 'Config Time' actions taken";
|
|
1038
1039
|
attribute :>> subjectDescription = "Data configuration";
|
|
1039
1040
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 57)";
|
|
@@ -1044,7 +1045,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1044
1045
|
attribute :>> statement = "When the clinician has attempted to configure the data for more than Max_Config_Duration_const continuously, the system shall clear all unsaved prescription values and shall perform actions as described in REQ 59 for 'Unsaved Configuration Cleared'.";
|
|
1045
1046
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1046
1047
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1047
|
-
attribute :>>
|
|
1048
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1048
1049
|
attribute :>> acceptanceCriteria = "continuous configuration time > Max_Config_Duration_const => unsaved values cleared ('Unsaved Configuration Cleared' is referenced by the source but absent from the REQ 59 table — a documented source inconsistency).";
|
|
1049
1050
|
attribute :>> subjectDescription = "Data configuration";
|
|
1050
1051
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 58)";
|
|
@@ -1057,7 +1058,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1057
1058
|
attribute :>> statement = "The system shall perform all the actions listed in the notification action table for the respective notification. The table defines, for each of the 20 notifications, its priority (High/Med/Low) and the actions Visual, Audio, Inhibit Infusion, Inhibit Square Bolus, Inhibit Patient Bolus, and Stop Bolus. Notification requirements have higher precedence over all other requirements in the system.";
|
|
1058
1059
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1059
1060
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1060
|
-
attribute :>>
|
|
1061
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1061
1062
|
attribute :>> acceptanceCriteria = "For every raised notification, the actions equal the NOTIF-01..NOTIF-20 table row: Inhibit Infusion => Inhibited_Infusion_macro = TRUE; Inhibit Square Bolus => Inhibited_Bolus_macro = TRUE; Inhibit Patient Bolus => Inhibited_PatientBolus_macro = TRUE; Stop Bolus => stop all boluses in progress.";
|
|
1062
1063
|
attribute :>> subjectDescription = "Notification handling (see NOTIF-01..NOTIF-20)";
|
|
1063
1064
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 59)";
|
|
@@ -1068,7 +1069,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1068
1069
|
attribute :>> statement = "When more than one notification having different priorities occurs at the same time, the system shall take actions listed for the highest priority notification.";
|
|
1069
1070
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1070
1071
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1071
|
-
attribute :>>
|
|
1072
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1072
1073
|
attribute :>> acceptanceCriteria = "Simultaneous notifications with different priorities => actions of the highest priority notification are taken.";
|
|
1073
1074
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1074
1075
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 60)";
|
|
@@ -1079,7 +1080,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1079
1080
|
attribute :>> statement = "When more than one notification having same priorities and different set of actions occurs at the same time, the system shall take actions listed for the most restrictive notification.";
|
|
1080
1081
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1081
1082
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1082
|
-
attribute :>>
|
|
1083
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1083
1084
|
attribute :>> acceptanceCriteria = "Order of restriction: Inhibit All Infusion > Inhibit Square Bolus > Inhibit Patient Bolus.";
|
|
1084
1085
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1085
1086
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 61)";
|
|
@@ -1090,7 +1091,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1090
1091
|
attribute :>> statement = "When more than one notification having same priorities and same set of actions occurs at the same time, the system will take actions for the notification that has the most restrictive actions as listed in REQ 59.";
|
|
1091
1092
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1092
1093
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1093
|
-
attribute :>>
|
|
1094
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1094
1095
|
attribute :>> acceptanceCriteria = "Tie on priority and actions => REQ 59 restriction ordering breaks the tie.";
|
|
1095
1096
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1096
1097
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 62)";
|
|
@@ -1101,7 +1102,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1101
1102
|
attribute :>> statement = "While a low priority or less restrictive notification is in effect and a higher priority or more restrictive same-priority notification occurs, the system shall take actions for the high priority or more restrictive notification as listed in REQ 59.";
|
|
1102
1103
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1103
1104
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1104
|
-
attribute :>>
|
|
1105
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1105
1106
|
attribute :>> acceptanceCriteria = "In-effect notification is superseded by a higher-priority or more restrictive notification.";
|
|
1106
1107
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1107
1108
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 63)";
|
|
@@ -1112,7 +1113,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1112
1113
|
attribute :>> statement = "While a high priority notification is in effect and a low priority notification occurs, the system shall only add the notification to the active notification list and shall not take any other actions for the low priority notification.";
|
|
1113
1114
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1114
1115
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1115
|
-
attribute :>>
|
|
1116
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1116
1117
|
attribute :>> acceptanceCriteria = "Lower-priority notification is listed but its actions are not taken while a higher-priority notification is in effect.";
|
|
1117
1118
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1118
1119
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 64)";
|
|
@@ -1123,7 +1124,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1123
1124
|
attribute :>> statement = "The system shall allow the clinician to cancel the active notifications, starting from the first in the list, one at a time (Notification_cancel_prog).";
|
|
1124
1125
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1125
1126
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1126
|
-
attribute :>>
|
|
1127
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1127
1128
|
attribute :>> acceptanceCriteria = "Cancellation proceeds one notification at a time from the head of the list.";
|
|
1128
1129
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1129
1130
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 65)";
|
|
@@ -1134,7 +1135,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1134
1135
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system shall cancel and clear the restrictions for that notification: Inhibited_Infusion_macro = FALSE, Inhibited_Bolus_macro = FALSE, Inhibited_PatientBolus_macro = FALSE, and cancel and clear the corresponding audio notification.";
|
|
1135
1136
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1136
1137
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1137
|
-
attribute :>>
|
|
1138
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1138
1139
|
attribute :>> acceptanceCriteria = "After cancel: Inhibited_Infusion_macro = FALSE AND Inhibited_Bolus_macro = FALSE AND Inhibited_PatientBolus_macro = FALSE AND audio cleared for that notification.";
|
|
1139
1140
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1140
1141
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 66)";
|
|
@@ -1145,7 +1146,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1145
1146
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system takes actions for the next active notification in order of priority and descending order of occurrence.";
|
|
1146
1147
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1147
1148
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1148
|
-
attribute :>>
|
|
1149
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1149
1150
|
attribute :>> acceptanceCriteria = "After cancel, the next active notification (by priority, then recency) becomes the notification in effect.";
|
|
1150
1151
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1151
1152
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 67)";
|
|
@@ -1158,7 +1159,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1158
1159
|
attribute :>> statement = "The system shall display all active notifications in order of priority and descending order of occurrence (Notification_Visual_output).";
|
|
1159
1160
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1160
1161
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1161
|
-
attribute :>>
|
|
1162
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1162
1163
|
attribute :>> acceptanceCriteria = "Notification_Visual_output lists active notifications ordered by priority, then most recent first.";
|
|
1163
1164
|
attribute :>> subjectDescription = "Visual notification";
|
|
1164
1165
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 68)";
|
|
@@ -1169,7 +1170,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1169
1170
|
attribute :>> statement = "The system shall display the name of all the active notifications and the time of the occurrence.";
|
|
1170
1171
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1171
1172
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1172
|
-
attribute :>>
|
|
1173
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1173
1174
|
attribute :>> acceptanceCriteria = "Every active notification is shown with name and occurrence time.";
|
|
1174
1175
|
attribute :>> subjectDescription = "Visual notification";
|
|
1175
1176
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 69)";
|
|
@@ -1180,7 +1181,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1180
1181
|
attribute :>> statement = "When more than one notification occurs at the same time, the system shall display all the notifications as per REQ 68.";
|
|
1181
1182
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1182
1183
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1183
|
-
attribute :>>
|
|
1184
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1184
1185
|
attribute :>> acceptanceCriteria = "Simultaneous notifications are all displayed in REQ 68 order.";
|
|
1185
1186
|
attribute :>> subjectDescription = "Visual notification";
|
|
1186
1187
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 70)";
|
|
@@ -1191,7 +1192,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1191
1192
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system shall remove the notification from the list and shall display the list of remaining notifications.";
|
|
1192
1193
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1193
1194
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1194
|
-
attribute :>>
|
|
1195
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1195
1196
|
attribute :>> acceptanceCriteria = "Cancelled notification disappears from the displayed list; remaining list stays displayed.";
|
|
1196
1197
|
attribute :>> subjectDescription = "Visual notification";
|
|
1197
1198
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 71)";
|
|
@@ -1204,7 +1205,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1204
1205
|
attribute :>> statement = "When each notification occurs that requires an audio alarm as listed in REQ 59, the system shall produce a single audible sound of Audio_level_const, unless the audio is disabled or silenced.";
|
|
1205
1206
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1206
1207
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1207
|
-
attribute :>>
|
|
1208
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1208
1209
|
attribute :>> acceptanceCriteria = "Audio-flagged notification => one audible sound at Audio_level_const (50 db for 2 seconds per I 8) unless Disable_audio_prog is set.";
|
|
1209
1210
|
attribute :>> subjectDescription = "Audio notification";
|
|
1210
1211
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 72)";
|
|
@@ -1215,7 +1216,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1215
1216
|
attribute :>> statement = "The system shall allow the clinician to disable audible alarm, silence the alarm temporarily and enable a disabled or silenced alarm.";
|
|
1216
1217
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1217
1218
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1218
|
-
attribute :>>
|
|
1219
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1219
1220
|
attribute :>> acceptanceCriteria = "Notification_Audio_output = FALSE if Disable_audio_prog = 'PERM' (disabled) or 'TEMP' (silenced); Notification_Audio_output = TRUE if Disable_audio_prog = FALSE.";
|
|
1220
1221
|
attribute :>> subjectDescription = "Audio notification";
|
|
1221
1222
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 73)";
|
|
@@ -1226,7 +1227,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1226
1227
|
attribute :>> statement = "If Disable_audio_prog = 'PERM' or 'TEMP', the system shall not produce audible alarm until it is enabled (Disable_audio_prog = FALSE).";
|
|
1227
1228
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1228
1229
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1229
|
-
attribute :>>
|
|
1230
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1230
1231
|
attribute :>> acceptanceCriteria = "No audible alarm while Disable_audio_prog is 'PERM' or 'TEMP'.";
|
|
1231
1232
|
attribute :>> subjectDescription = "Audio notification";
|
|
1232
1233
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 74)";
|
|
@@ -1237,7 +1238,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1237
1238
|
attribute :>> statement = "If Disable_audio_prog = 'TEMP', the system shall automatically enable it (Disable_audio_prog = FALSE) after Audio_Enable_Duration_const minutes.";
|
|
1238
1239
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1239
1240
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1240
|
-
attribute :>>
|
|
1241
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1241
1242
|
attribute :>> acceptanceCriteria = "Temporary silence expires after Audio_Enable_Duration_const (30) minutes.";
|
|
1242
1243
|
attribute :>> subjectDescription = "Audio notification";
|
|
1243
1244
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 75)";
|
|
@@ -1248,7 +1249,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1248
1249
|
attribute :>> statement = "For every notification with audio alarm that is active for more than Audio_Enable_Duration_const minutes, the system shall produce audible sound as described in REQ 72.";
|
|
1249
1250
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1250
1251
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1251
|
-
attribute :>>
|
|
1252
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1252
1253
|
attribute :>> acceptanceCriteria = "Audio-flagged notification active > Audio_Enable_Duration_const minutes => REQ 72 sound re-produced.";
|
|
1253
1254
|
attribute :>> subjectDescription = "Audio notification";
|
|
1254
1255
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 76)";
|
|
@@ -1261,7 +1262,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1261
1262
|
attribute :>> statement = "The system shall log all the operational and error data when the system is in ON mode.";
|
|
1262
1263
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1263
1264
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1264
|
-
attribute :>>
|
|
1265
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1265
1266
|
attribute :>> acceptanceCriteria = "Operational log and error log are recorded whenever the system is in ON mode.";
|
|
1266
1267
|
attribute :>> subjectDescription = "Logging";
|
|
1267
1268
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 77)";
|
|
@@ -1272,7 +1273,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1272
1273
|
attribute :>> statement = "While in ON mode, every Log_Interval_const minutes or when a mode transition occurs, the system shall record the following information in an 'Operational log': (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) Patient ID, (4) prescription information, (5) current mode of the system, (6) current flow rate of the system.";
|
|
1273
1274
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1274
1275
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1275
|
-
attribute :>>
|
|
1276
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1276
1277
|
attribute :>> acceptanceCriteria = "Operational log entries appear every Log_Interval_const (5) minutes and on every mode transition, with all six fields.";
|
|
1277
1278
|
attribute :>> subjectDescription = "Logging";
|
|
1278
1279
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 78)";
|
|
@@ -1283,7 +1284,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1283
1284
|
attribute :>> statement = "When infusion is completed as per REQ 28, the system shall record the following information in addition to the information listed in REQ 78 in the 'Operational log': (1) total volume infused for that prescription, (2) total duration of infusion for that prescription (total duration in ACTIVE mode).";
|
|
1284
1285
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1285
1286
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1286
|
-
attribute :>>
|
|
1287
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1287
1288
|
attribute :>> acceptanceCriteria = "Infusion-complete log entry includes total volume infused and total ACTIVE-mode duration.";
|
|
1288
1289
|
attribute :>> subjectDescription = "Logging";
|
|
1289
1290
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 79)";
|
|
@@ -1294,7 +1295,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1294
1295
|
attribute :>> statement = "When any notification condition listed in REQ 59 occurs, the system shall record the following information in an error log: (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) notification description, (4) current mode of the system, (5) remaining drug volume.";
|
|
1295
1296
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1296
1297
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1297
|
-
attribute :>>
|
|
1298
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1298
1299
|
attribute :>> acceptanceCriteria = "Every REQ 59 notification produces an error log entry with all five fields.";
|
|
1299
1300
|
attribute :>> subjectDescription = "Logging";
|
|
1300
1301
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 80)";
|
|
@@ -1305,7 +1306,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1305
1306
|
attribute :>> statement = "When a notification is cancelled as described in REQ 66, the system shall record the following information in the 'Operational log': (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) description of the notification cancelled.";
|
|
1306
1307
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1307
1308
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1308
|
-
attribute :>>
|
|
1309
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1309
1310
|
attribute :>> acceptanceCriteria = "Every notification cancellation produces an operational log entry with all three fields.";
|
|
1310
1311
|
attribute :>> subjectDescription = "Logging";
|
|
1311
1312
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 81)";
|
|
@@ -1318,7 +1319,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1318
1319
|
attribute :>> statement = "The system shall allow only authorized clinicians to configure the system.";
|
|
1319
1320
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1320
1321
|
attribute :>> concernKind = ConcernKind::cybersecurity;
|
|
1321
|
-
attribute :>>
|
|
1322
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1322
1323
|
attribute :>> acceptanceCriteria = "Configuration is rejected for unauthorized users.";
|
|
1323
1324
|
attribute :>> subjectDescription = "System configuration access";
|
|
1324
1325
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.5 (REQ 82)";
|
|
@@ -1331,7 +1332,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1331
1332
|
attribute :>> statement = "The system shall be unbreakable if it is dropped on a laminate floor from y m of height with no additional force than gravity.";
|
|
1332
1333
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1333
1334
|
attribute :>> concernKind = ConcernKind::reliability;
|
|
1334
|
-
attribute :>>
|
|
1335
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1335
1336
|
attribute :>> acceptanceCriteria = "Drop from height y m (value left open by the source) onto laminate floor causes no breakage.";
|
|
1336
1337
|
attribute :>> subjectDescription = "GPCA enclosure";
|
|
1337
1338
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 83)";
|
|
@@ -1342,7 +1343,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1342
1343
|
attribute :>> statement = "The system shall be waterproof to non-acidic liquid of less than x ml on any side of the pump for a maximum of 2 hours.";
|
|
1343
1344
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1344
1345
|
attribute :>> concernKind = ConcernKind::reliability;
|
|
1345
|
-
attribute :>>
|
|
1346
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1346
1347
|
attribute :>> acceptanceCriteria = "Exposure to < x ml (value left open by the source) non-acidic liquid for up to 2 hours causes no ingress failure.";
|
|
1347
1348
|
attribute :>> subjectDescription = "GPCA enclosure";
|
|
1348
1349
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 84)";
|
|
@@ -1353,7 +1354,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1353
1354
|
attribute :>> statement = "The system shall persist the most recent 30 days of error log data and 15 days of operational log data.";
|
|
1354
1355
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1355
1356
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1356
|
-
attribute :>>
|
|
1357
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1357
1358
|
attribute :>> acceptanceCriteria = "error log retention >= Error_Log_Retention (30 days); operational log retention >= Operational_Log_Retention (15 days)";
|
|
1358
1359
|
attribute :>> subjectDescription = "Logging";
|
|
1359
1360
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 85)";
|
|
@@ -1364,7 +1365,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1364
1365
|
attribute :>> statement = "The system shall persist the last saved prescription data for 15 days.";
|
|
1365
1366
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1366
1367
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1367
|
-
attribute :>>
|
|
1368
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1368
1369
|
attribute :>> acceptanceCriteria = "saved prescription retention >= Prescription_Persist_Duration (15 days)";
|
|
1369
1370
|
attribute :>> subjectDescription = "Prescription storage";
|
|
1370
1371
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 86)";
|
|
@@ -1381,7 +1382,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1381
1382
|
attribute :>> statement = "When a prescription parameter is entered, the system shall reject values outside drug-library hard limits and shall require explicit confirmation for values outside soft limits.";
|
|
1382
1383
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1383
1384
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1384
|
-
attribute :>>
|
|
1385
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1385
1386
|
attribute :>> acceptanceCriteria = "Hard-limit violations cannot be saved; soft-limit violations require a distinct confirmation step; both are logged.";
|
|
1386
1387
|
attribute :>> subjectDescription = "Config";
|
|
1387
1388
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1400,7 +1401,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1400
1401
|
attribute :>> statement = "On power-up, the system shall complete a self test of CPU, memory, watchdog, and safety sensors before permitting therapy, and shall remain locked out of therapy if any check fails.";
|
|
1401
1402
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1402
1403
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1403
|
-
attribute :>>
|
|
1404
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1404
1405
|
attribute :>> acceptanceCriteria = "Failed POST inhibits all infusion modes and raises a High-priority notification.";
|
|
1405
1406
|
attribute :>> subjectDescription = "System_Monitor and Top_Level_Mode";
|
|
1406
1407
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1419,7 +1420,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1419
1420
|
attribute :>> statement = "If all power is lost, the system shall retain the confirmed prescription and event log, and on power restoration shall resume therapy only after clinician confirmation.";
|
|
1420
1421
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1421
1422
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1422
|
-
attribute :>>
|
|
1423
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1423
1424
|
attribute :>> acceptanceCriteria = "Stored prescription checksum verifies after power cycle; therapy does not auto-resume. Retention durations remain governed by REQ-CS-85/86.";
|
|
1424
1425
|
attribute :>> subjectDescription = "Config and Top_Level_Mode";
|
|
1425
1426
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1439,7 +1440,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1439
1440
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1440
1441
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1441
1442
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1442
|
-
attribute :>>
|
|
1443
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1443
1444
|
attribute :>> acceptanceCriteria = "Occlusion above threshold pauses infusion within one execution step and annunciates. Complements REQ-CS-17 under-infusion detection with a direct pressure measurement.";
|
|
1444
1445
|
attribute :>> subjectDescription = "Alarm and Infusion_Manager";
|
|
1445
1446
|
attribute :>> actorDescription = "patient";
|
|
@@ -1454,7 +1455,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1454
1455
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1455
1456
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1456
1457
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1457
|
-
attribute :>>
|
|
1458
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1458
1459
|
attribute :>> acceptanceCriteria = "Flow command forced to zero whenever door state is open; notification raised on transition during ACTIVE.";
|
|
1459
1460
|
attribute :>> subjectDescription = "Infusion_Manager";
|
|
1460
1461
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1474,7 +1475,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1474
1475
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1475
1476
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1476
1477
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1477
|
-
attribute :>>
|
|
1478
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1478
1479
|
attribute :>> acceptanceCriteria = "Cumulative delivered volume in every one-hour window is at or below the prescribed maximum. Complements the CriSys total-VTBI ceiling (REQ-CS-20, REQ-CS-28).";
|
|
1479
1480
|
attribute :>> subjectDescription = "Infusion_Manager";
|
|
1480
1481
|
attribute :>> actorDescription = "patient";
|
|
@@ -1489,7 +1490,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1489
1490
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1490
1491
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1491
1492
|
attribute :>> safetyClass = SafetyClassKind::B;
|
|
1492
|
-
attribute :>>
|
|
1493
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1493
1494
|
attribute :>> acceptanceCriteria = "Modification of a stored log entry is detectable. Log content and cadence are governed by REQ-CS-77..81; retention by REQ-CS-85.";
|
|
1494
1495
|
attribute :>> subjectDescription = "Logging";
|
|
1495
1496
|
attribute :>> actorDescription = "clinician and auditor";
|
|
@@ -1504,7 +1505,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1504
1505
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1505
1506
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1506
1507
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1507
|
-
attribute :>>
|
|
1508
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1508
1509
|
attribute :>> acceptanceCriteria = "Induced CPU hang results in zero flow and alarm within the watchdog timeout.";
|
|
1509
1510
|
attribute :>> subjectDescription = "System_Monitor and watchdog hardware";
|
|
1510
1511
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1524,7 +1525,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1524
1525
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1525
1526
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1526
1527
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1527
|
-
attribute :>>
|
|
1528
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1528
1529
|
attribute :>> acceptanceCriteria = "Continuous assertion beyond 60 s produces no bolus and raises a notification. Complements REQ-CS-25/26 request-level filtering with an input-failure check.";
|
|
1529
1530
|
attribute :>> subjectDescription = "Infusion_Manager";
|
|
1530
1531
|
attribute :>> actorDescription = "patient";
|
|
@@ -1539,7 +1540,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1539
1540
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1540
1541
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1541
1542
|
attribute :>> safetyClass = SafetyClassKind::C;
|
|
1542
|
-
attribute :>>
|
|
1543
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1543
1544
|
attribute :>> acceptanceCriteria = "Injected flow deviation beyond Tolerance_Min_const (5 %) sustained past Max_Duration_OverInfusion_const pauses therapy and annunciates; detection is independent of motor control.";
|
|
1544
1545
|
attribute :>> subjectDescription = "Alarm and Infusion_Manager";
|
|
1545
1546
|
attribute :>> actorDescription = "patient";
|
|
@@ -1553,7 +1554,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1553
1554
|
attribute :>> statement = "The pump mechanism shall deliver programmed volumes with an accuracy of plus or minus Tolerance_Min_const (5 percent) over the full rate range, so that the system-level flow tolerances of REQ-CS-16 are achievable.";
|
|
1554
1555
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1555
1556
|
attribute :>> concernKind = ConcernKind::performance;
|
|
1556
|
-
attribute :>>
|
|
1557
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1557
1558
|
attribute :>> acceptanceCriteria = "Gravimetric bench test across min/nominal/max rates within ±5% (Tolerance_Min_const).";
|
|
1558
1559
|
attribute :>> subjectDescription = "PumpMotorAssembly";
|
|
1559
1560
|
attribute :>> actorDescription = "patient";
|
|
@@ -1568,7 +1569,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1568
1569
|
attribute :>> statement = "The audible annunciator shall produce notification tones at the sound level defined by Audio_level_const (50 db for 2 seconds per interface spec I 8), distinguishable by priority.";
|
|
1569
1570
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1570
1571
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1571
|
-
attribute :>>
|
|
1572
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1572
1573
|
attribute :>> acceptanceCriteria = "Calibrated SPL measurement meets Audio_level_const for each priority tone.";
|
|
1573
1574
|
attribute :>> subjectDescription = "AudibleAlarmAnnunciator";
|
|
1574
1575
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1583,7 +1584,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1583
1584
|
attribute :>> statement = "The battery shall sustain nominal therapy and alarm annunciation for at least 4 hours after loss of mains power.";
|
|
1584
1585
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1585
1586
|
attribute :>> concernKind = ConcernKind::reliability;
|
|
1586
|
-
attribute :>>
|
|
1587
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1587
1588
|
attribute :>> acceptanceCriteria = "Discharge test at nominal rate exceeds 4 h with low-battery warning at 30 min remaining.";
|
|
1588
1589
|
attribute :>> subjectDescription = "BatteryPack";
|
|
1589
1590
|
attribute :>> actorDescription = "clinician";
|
|
@@ -1598,7 +1599,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1598
1599
|
attribute :>> statement = "The fluid path shall include a mechanical anti-free-flow valve that blocks gravity flow whenever the administration set is disengaged from the pumping mechanism.";
|
|
1599
1600
|
attribute :>> sourceKind = RequirementSourceKind::extension;
|
|
1600
1601
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1601
|
-
attribute :>>
|
|
1602
|
+
attribute :>> status = ElementStatusKind::approved;
|
|
1602
1603
|
attribute :>> acceptanceCriteria = "No measurable flow under gravity head with set disengaged and door open.";
|
|
1603
1604
|
attribute :>> subjectDescription = "AntiFreeFlowValve";
|
|
1604
1605
|
attribute :>> actorDescription = "patient";
|