@memoarchitect/ontology 0.7.0 → 0.8.24

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.
Files changed (270) hide show
  1. package/README.md +4 -2
  2. package/examples/connected-patient-monitor/memo.package.yaml +3 -0
  3. package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +1 -1
  4. package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/views/connected_patient_monitor_overview.sysml +1 -1
  5. package/examples/embedded-infusion-pump/memo.package.yaml +3 -0
  6. package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +8 -6
  7. package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/views/embedded_infusion_pump_overview.sysml +1 -1
  8. package/examples/functional-logical-physical/memo.package.yaml +3 -0
  9. package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +6 -6
  10. package/examples/functional-logical-physical/model/catalog/viewpoints/unassigned/views/functional_logical_physical_overview.sysml +1 -1
  11. package/examples/gpca-pump/memo.package.yaml +3 -0
  12. package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +18 -8
  13. package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +341 -99
  14. package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +25 -11
  15. package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +328 -271
  16. package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +52 -11
  17. package/examples/gpca-pump/model/catalog/gpca_context.sysml +14 -3
  18. package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +8 -5
  19. package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +175 -259
  20. package/examples/gpca-pump/model/catalog/gpca_operational.sysml +97 -103
  21. package/examples/gpca-pump/model/catalog/gpca_physical.sysml +5 -10
  22. package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +101 -100
  23. package/examples/gpca-pump/model/catalog/gpca_standards.sysml +161 -0
  24. package/examples/gpca-pump/model/catalog/gpca_system.sysml +17 -17
  25. package/examples/gpca-pump/model/catalog/gpca_trace.sysml +274 -334
  26. package/examples/gpca-pump/model/catalog/gpca_verification.sysml +115 -35
  27. package/examples/gpca-pump/model/catalog/project.sysml +5 -0
  28. package/examples/gpca-pump/model/catalog/viewpoints/context/views/context_system_context_view.sysml +2 -4
  29. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/cybersecurity_cybersecurity_view.sysml +2 -4
  30. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_cyber_assessment_view.sysml +1 -4
  31. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_threat_model_view.sysml +2 -5
  32. package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_allocation_view.sysml +1 -3
  33. package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_browser_view.sysml +1 -3
  34. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/behavior_action_flow_view.sysml +1 -3
  35. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/document_architecture_description_view.sysml +4 -7
  36. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_device_interconnect_view.sysml +3 -5
  37. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_logical_architecture_view.sysml +1 -3
  38. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_mode_state_view.sysml +2 -4
  39. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_system_decomposition_view.sysml +1 -3
  40. package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_scenario_sequence_view.sysml +2 -4
  41. package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_use_case_view.sysml +2 -4
  42. package/examples/gpca-pump/model/catalog/viewpoints/physical/views/physical_physical_bom_view.sysml +1 -3
  43. package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/document_dhf_index_view.sysml +5 -8
  44. package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/requirements_requirements_trace_view.sysml +1 -3
  45. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_hazard_analysis_view.sysml +6 -6
  46. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_rmf_view.sysml +5 -6
  47. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_fmea_view.sysml +2 -4
  48. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_risk_chain_view.sysml +1 -3
  49. package/examples/gpca-pump/model/catalog/viewpoints/software/views/document_sdd_view.sysml +2 -5
  50. package/examples/gpca-pump/model/catalog/viewpoints/software/views/software_software_architecture_view.sysml +3 -5
  51. package/examples/gpca-pump/model/catalog/viewpoints/usability/views/document_usability_view.sysml +5 -6
  52. package/examples/gpca-pump/model/catalog/viewpoints/verification/views/document_vv_view.sysml +5 -6
  53. package/examples/gpca-pump/model/catalog/viewpoints/verification/views/verification_verification_coverage_view.sysml +2 -4
  54. package/examples/ivd-laboratory-system/memo.package.yaml +3 -0
  55. package/examples/ivd-laboratory-system/model/catalog/ivd_laboratory_system.sysml +1 -1
  56. package/examples/ivd-laboratory-system/model/catalog/viewpoints/unassigned/views/ivd_laboratory_system_overview.sysml +1 -1
  57. package/examples/manual-surgical-instrument/memo.package.yaml +3 -0
  58. package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +4 -3
  59. package/examples/manual-surgical-instrument/model/catalog/viewpoints/unassigned/views/manual_surgical_instrument_overview.sysml +1 -1
  60. package/examples/multidimensional-layers/memo.package.yaml +3 -0
  61. package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -2
  62. package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/views/multidimensional_layers_overview.sysml +0 -1
  63. package/examples/nested-architecture-dsm/memo.package.yaml +3 -0
  64. package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +133 -128
  65. package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +139 -157
  66. package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +56 -33
  67. package/examples/nested-architecture-dsm/model/catalog/traces.sysml +25 -26
  68. package/examples/reusable-instrument/memo.package.yaml +3 -0
  69. package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +16 -23
  70. package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/views/reusable_instrument_overview.sysml +0 -1
  71. package/examples/ros-mobile-robot/README.md +40 -0
  72. package/examples/ros-mobile-robot/memo.package.yaml +3 -0
  73. package/examples/ros-mobile-robot/model/catalog/project.sysml +33 -0
  74. package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +296 -0
  75. package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +7 -0
  76. package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/views/ros_mobile_robot_overview.sysml +12 -0
  77. package/examples/software-only-medical-device/memo.package.yaml +3 -0
  78. package/examples/software-only-medical-device/model/catalog/project.sysml +4 -0
  79. package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +12 -6
  80. package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/views/software_only_medical_device_overview.sysml +0 -1
  81. package/examples/surgical-closure-workflow/memo.package.yaml +3 -0
  82. package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +58 -75
  83. package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/views/surgical_closure_workflow_overview.sysml +0 -1
  84. package/examples/surgical-robot/memo.package.yaml +3 -0
  85. package/examples/surgical-robot/model/catalog/surgical_robot.sysml +1 -1
  86. package/examples/surgical-robot/model/catalog/viewpoints/unassigned/views/surgical_robot_overview.sysml +0 -1
  87. package/examples/sysml-diagram-samples/memo.package.yaml +2 -0
  88. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/action_flow_view.sysml +12 -18
  89. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.sysml +8 -11
  90. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +43 -68
  91. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +57 -68
  92. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +40 -70
  93. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/requirements_view.sysml +4 -8
  94. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +1 -20
  95. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +52 -84
  96. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +22 -33
  97. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/use_case_view.sysml +13 -10
  98. package/examples/temperature-alarm/memo.package.yaml +3 -0
  99. package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +28 -25
  100. package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/views/temperature_alarm_overview.sysml +0 -1
  101. package/examples/ui-screen-regions/memo.package.yaml +3 -0
  102. package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +57 -33
  103. package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +102 -79
  104. package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +5 -5
  105. package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +21 -6
  106. package/examples/ui-screen-regions/model/catalog/relationships.sysml +8 -0
  107. package/examples/ui-screen-regions/model/catalog/traces.sysml +28 -125
  108. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +2 -3
  109. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +1 -2
  110. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +1 -2
  111. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +1 -2
  112. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +1 -2
  113. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +1 -2
  114. package/extensions/LICENSES/MIT.txt +19 -0
  115. package/extensions/README.md +94 -0
  116. package/extensions/aadl/memo.package.yaml +18 -0
  117. package/extensions/aadl/src/aadl_extension.sysml +6 -0
  118. package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +147 -0
  119. package/extensions/aadl/src/methodology/aadl_methodology.sysml +17 -0
  120. package/extensions/aadl/src/runtime/memo_aadl_runtime.sysml +56 -0
  121. package/extensions/cloud/memo.package.yaml +18 -0
  122. package/extensions/cloud/src/cloud_extension.sysml +44 -0
  123. package/extensions/cloud/src/methodology/cloud_methodology.sysml +17 -0
  124. package/extensions/container/memo.package.yaml +18 -0
  125. package/extensions/container/src/container_extension.sysml +37 -0
  126. package/extensions/container/src/methodology/container_methodology.sysml +17 -0
  127. package/extensions/messaging/memo.package.yaml +18 -0
  128. package/extensions/messaging/src/messaging_extension.sysml +64 -0
  129. package/extensions/messaging/src/methodology/messaging_methodology.sysml +17 -0
  130. package/extensions/ros/memo.package.yaml +18 -0
  131. package/extensions/ros/src/methodology/ros_methodology.sysml +25 -0
  132. package/extensions/ros/src/ros_extension.sysml +200 -0
  133. package/extensions/template/src/extension.sysml +37 -0
  134. package/memo.manifest.yaml +13 -2
  135. package/methodologies/default/memo.package.yaml +1 -1
  136. package/methodologies/gpca/memo.package.yaml +1 -1
  137. package/ontology/memo.package.yaml +1 -1
  138. package/package.json +5 -3
  139. package/profile/memo.package.yaml +1 -1
  140. package/src/architecture/decisions/memo_decisions.sysml +23 -2
  141. package/src/architecture/functional/behavior/memo_behavior.sysml +51 -23
  142. package/src/architecture/functional/constraints/memo_constraints.sysml +3 -2
  143. package/src/architecture/functional/functions/memo_functions.sysml +93 -36
  144. package/src/architecture/implementation/hardware/common/memo_hardware_common.sysml +2 -2
  145. package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +46 -22
  146. package/src/architecture/implementation/software/structure/memo_software_structure.sysml +40 -13
  147. package/src/architecture/implementation/ui/memo_ui.sysml +83 -43
  148. package/src/architecture/logical/interfaces/memo_interfaces.sysml +64 -12
  149. package/src/architecture/logical/structure/memo_logical_structure.sysml +26 -25
  150. package/src/architecture/operational/activities/memo_activities.sysml +27 -29
  151. package/src/architecture/operational/context/actors/memo_actors.sysml +8 -10
  152. package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +16 -33
  153. package/src/architecture/operational/context/use_context/memo_use_context.sysml +42 -17
  154. package/src/architecture/operational/scenarios/memo_scenarios.sysml +36 -84
  155. package/src/architecture/operational/structure/memo_operational.sysml +42 -13
  156. package/src/architecture/operational/use_cases/memo_use_cases.sysml +35 -27
  157. package/src/architecture/operational/workflows/memo_workflows.sysml +45 -28
  158. package/src/architecture/realization/deployment/memo_deployment.sysml +115 -20
  159. package/src/architecture/realization/physical/memo_physical_architecture.sysml +29 -4
  160. package/src/artifacts/configuration_management/memo_configuration_management.sysml +16 -0
  161. package/src/artifacts/core/memo_controlled_artifacts.sysml +3 -1
  162. package/src/artifacts/standards/cfr_21_820.sysml +116 -0
  163. package/src/artifacts/standards/fda_cybersecurity_2023.sysml +80 -0
  164. package/src/artifacts/standards/iec_60601_1.sysml +149 -0
  165. package/src/artifacts/standards/iec_60601_1_2.sysml +56 -0
  166. package/src/artifacts/standards/iec_60812.sysml +51 -0
  167. package/src/artifacts/standards/iec_62304.sysml +210 -0
  168. package/src/artifacts/standards/iec_62366_1.sysml +113 -0
  169. package/src/artifacts/standards/iec_81001_5_1.sysml +84 -0
  170. package/src/artifacts/standards/iso_13485.sysml +113 -0
  171. package/src/artifacts/standards/iso_14971.sysml +94 -0
  172. package/src/artifacts/standards/iso_iec_ieee_42010.sysml +42 -0
  173. package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml +132 -0
  174. package/src/artifacts/templates/dhf/21cfr820/design-input.md +1 -1
  175. package/src/artifacts/templates/dhf/21cfr820/design-output.md +5 -5
  176. package/src/artifacts/templates/dhf/21cfr820/design-review.md +1 -1
  177. package/src/artifacts/templates/dhf/21cfr820/design-validation.md +2 -2
  178. package/src/artifacts/templates/dhf/21cfr820/design-verification.md +2 -2
  179. package/src/artifacts/templates/dhf/21cfr820/dhf-index.md +2 -2
  180. package/src/artifacts/templates/dhf/21cfr820/transfer-plan.md +1 -1
  181. package/src/artifacts/templates/dhf/21cfr820/user-needs.md +1 -1
  182. package/src/artifacts/templates/dhf/21cfr820/vv-plan.md +3 -3
  183. package/src/artifacts/templates/dhf/21cfr820/vv-report.md +4 -4
  184. package/src/artifacts/templates/dhf/fda-cybersecurity/incident-response.md +1 -1
  185. package/src/artifacts/templates/dhf/fda-cybersecurity/postmarket-surveillance.md +3 -2
  186. package/src/artifacts/templates/dhf/fda-cybersecurity/security-arch.md +2 -2
  187. package/src/artifacts/templates/dhf/fda-cybersecurity/threat-model.md +4 -4
  188. package/src/artifacts/templates/dhf/fda-cybersecurity/vuln-assessment.md +4 -3
  189. package/src/artifacts/templates/dhf/iec-60601/hrs.md +170 -0
  190. package/src/artifacts/templates/dhf/iec-62304/detailed-design.md +1 -1
  191. package/src/artifacts/templates/dhf/iec-62304/integration-test.md +3 -3
  192. package/src/artifacts/templates/dhf/iec-62304/sad.md +6 -5
  193. package/src/artifacts/templates/dhf/iec-62304/sbom.md +3 -2
  194. package/src/artifacts/templates/dhf/iec-62304/sdp.md +5 -4
  195. package/src/artifacts/templates/dhf/iec-62304/soup.md +4 -2
  196. package/src/artifacts/templates/dhf/iec-62304/srs.md +54 -20
  197. package/src/artifacts/templates/dhf/iec-62304/sw-traceability.md +3 -3
  198. package/src/artifacts/templates/dhf/iec-62304/system-test.md +1 -1
  199. package/src/artifacts/templates/dhf/iec-62366/summative-eval.md +1 -1
  200. package/src/artifacts/templates/dhf/iec-62366/task-analysis.md +40 -4
  201. package/src/artifacts/templates/dhf/iec-62366/ue-plan.md +1 -1
  202. package/src/artifacts/templates/dhf/iec-62366/urra.md +3 -3
  203. package/src/artifacts/templates/dhf/iso-14971/fmea.md +42 -19
  204. package/src/artifacts/templates/dhf/iso-14971/har.md +3 -3
  205. package/src/artifacts/templates/dhf/iso-14971/rmp.md +2 -2
  206. package/src/artifacts/templates/dhf/system/sad.md +173 -0
  207. package/src/artifacts/templates/dhf/system/standards-checklist.md +87 -0
  208. package/src/artifacts/templates/dhf/system/standards-traceability.md +125 -0
  209. package/src/artifacts/templates/dhf/system/syrs.md +128 -0
  210. package/src/assurance/cybersecurity/memo_cybersecurity.sysml +40 -21
  211. package/src/assurance/human_factors/memo_human_factors.sysml +29 -22
  212. package/src/assurance/requirements/memo_requirements.sysml +7 -20
  213. package/src/assurance/requirements/needs/memo_needs.sysml +1 -1
  214. package/src/assurance/safety_risk/analysis/memo_fmea.sysml +118 -13
  215. package/src/assurance/safety_risk/memo_risk.sysml +90 -7
  216. package/src/assurance/safety_risk/postmarket_surveillance/memo_postmarket_surveillance.sysml +16 -0
  217. package/src/assurance/verification_validation/memo_assurance.sysml +17 -21
  218. package/src/core/annotations/memo_annotations.sysml +25 -6
  219. package/src/core/common/memo_common.sysml +130 -21
  220. package/src/core/consistency_rules/consistency_rules.sysml +1 -1
  221. package/src/core/dimensions/dimensions.sysml +12 -0
  222. package/src/core/enumerations/memo_enumerations.sysml +60 -14
  223. package/src/core/relationships/memo_relationships.sysml +199 -196
  224. package/src/memo_namespaces.sysml +30 -0
  225. package/src/methodology/core/memo_core.sysml +24 -0
  226. package/src/methodology/profiles/memo_profiles.sysml +1 -1
  227. package/src/methodology/workflow/memo_workflow.sysml +5 -5
  228. package/src/rules/closure/closure_rules.sysml +20 -20
  229. package/src/rules/crosslayer/cross_layer_rules.sysml +2 -2
  230. package/src/rules/ontology/ontology_invariants.sysml +223 -11
  231. package/src/rules/quantitative/quantitative_rules.sysml +2 -2
  232. package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +30 -30
  233. package/src/viewpoints/clinical/clinical_viewpoint.sysml +2 -3
  234. package/src/viewpoints/context/context_viewpoint.sysml +2 -3
  235. package/src/viewpoints/context/views/system_context_view/system_context_view.sysml +1 -2
  236. package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +2 -4
  237. package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +46 -3
  238. package/src/viewpoints/functional/functional_viewpoint.sysml +2 -3
  239. package/src/viewpoints/functional/views/function_allocation_view/function_allocation_view.sysml +2 -3
  240. package/src/viewpoints/functional/views/system_functional_tree_view/system_functional_tree_view.sysml +2 -3
  241. package/src/viewpoints/logical/logical_viewpoint.sysml +1 -2
  242. package/src/viewpoints/logical/views/logical_architecture_view/logical_architecture_view.sysml +1 -2
  243. package/src/viewpoints/operational/operational_viewpoint.sysml +2 -3
  244. package/src/viewpoints/operational/views/use_case_view/use_case_view.sysml +2 -3
  245. package/src/viewpoints/physical/physical_viewpoint.sysml +1 -2
  246. package/src/viewpoints/physical/views/network_topology_view/network_topology_view.sysml +1 -2
  247. package/src/viewpoints/physical/views/physical_bom_view/physical_bom_view.sysml +1 -2
  248. package/src/viewpoints/requirements/requirements_viewpoint.sysml +1 -2
  249. package/src/viewpoints/requirements/views/requirements_traceability_view/requirements_traceability_view.sysml +1 -2
  250. package/src/viewpoints/risk/risk_viewpoint.sysml +1 -2
  251. package/src/viewpoints/risk/views/risk_chain_view/risk_chain_view.sysml +1 -2
  252. package/src/viewpoints/software/software_viewpoint.sysml +1 -2
  253. package/src/viewpoints/software/views/software_architecture_view/software_architecture_view.sysml +1 -2
  254. package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +2 -3
  255. package/src/viewpoints/usability/usability_viewpoint.sysml +1 -2
  256. package/src/viewpoints/verification/verification_viewpoint.sysml +2 -3
  257. package/src/viewpoints/verification/views/verification_coverage_view/verification_coverage_view.sysml +2 -3
  258. package/templates/connected-device/memo.package.yaml +2 -0
  259. package/templates/default/memo.package.yaml +2 -0
  260. package/templates/infusion-pump/memo.package.yaml +2 -0
  261. package/templates/monitoring-device/memo.package.yaml +2 -0
  262. package/templates/samd/memo.package.yaml +2 -0
  263. package/examples/extensions/README.md +0 -16
  264. package/examples/extensions/template/src/extension.sysml +0 -15
  265. package/examples/gpca-pump/gpca-pump.kpar +0 -0
  266. /package/{examples/extensions → extensions}/clinical/memo.package.yaml +0 -0
  267. /package/{examples/extensions → extensions}/clinical/src/clinical_extension.sysml +0 -0
  268. /package/{examples/extensions → extensions}/clinical/src/methodology/clinical_methodology.sysml +0 -0
  269. /package/{examples/extensions → extensions}/clinical/src/procedures/memo_clinical_procedures.sysml +0 -0
  270. /package/{examples/extensions → extensions}/template/memo.package.yaml +0 -0
@@ -1,8 +1,16 @@
1
1
  package memo_examples_gpca_pump_gpca_verification {
2
+ private import memo_examples_gpca_pump_gpca_requirements::*;
3
+ private import memo_examples_gpca_pump_gpca_formal_behavior::*;
4
+ private import memo_examples_gpca_pump_gpca_architecture::*;
5
+ private import memo_examples_gpca_pump_gpca_risk::*;
6
+ private import memo_examples_gpca_pump_gpca_behavior_modes::*;
7
+ private import memo_examples_sysml_diagram_samples_viewpoints_unassigned_views_requirements_view::*;
2
8
  private import ScalarValues::*;
9
+ private import memo_core_dimensions::*; // ElementStatusKind
3
10
 
4
11
  private import memo_assurance_verification_validation::*;
5
12
  private import memo_core_enumerations::*;
13
+ private import memo_core_common::*;
6
14
 
7
15
  // ── Verification cases ──────────────────────────────────────
8
16
  verification vcModeRange : VerificationCase {
@@ -10,112 +18,155 @@ package memo_examples_gpca_pump_gpca_verification {
10
18
  attribute :>> name = "VerifyModeRange";
11
19
  attribute :>> methodKind = VerificationMethodKind::formalProof;
12
20
  attribute :>> acceptanceCriteria = "Current_System_mode only takes valid exclusive values";
13
- attribute :>> status = "planned";
21
+ attribute :>> status = ElementStatusKind::approved;
22
+
23
+ objective { verify reqCs01; }
24
+ subject verified : Base::Anything[*] = (guaranteeExclusiveMode, gpcaDevice.gpcaSoftware.tlm, gpcaDevice.gpcaSoftware.outputBus);
14
25
  }
15
26
  verification vcLockout : VerificationCase {
16
27
  attribute :>> id = "VER-002";
17
28
  attribute :>> name = "VerifyBolusLockout";
18
29
  attribute :>> methodKind = VerificationMethodKind::test;
19
30
  attribute :>> acceptanceCriteria = "No patient bolus initiated when lockout or max bolus constraints active";
20
- attribute :>> status = "planned";
31
+ attribute :>> status = ElementStatusKind::approved;
32
+
33
+ objective { verify reqCs25; }
34
+ subject verified : Base::Anything[*] = (lockoutControl, guaranteeLockoutPreventsBolus, tcBolusResponse, gpcaDevice.gpcaSoftware.infusionMgr);
21
35
  }
22
36
  verification vcSameStepAlarm : VerificationCase {
23
37
  attribute :>> id = "VER-003";
24
38
  attribute :>> name = "VerifySameStepAlarmStop";
25
39
  attribute :>> methodKind = VerificationMethodKind::modelChecking;
26
40
  attribute :>> acceptanceCriteria = "Alarm output affects infusion in same execution step";
27
- attribute :>> status = "planned";
41
+ attribute :>> status = ElementStatusKind::approved;
42
+
43
+ objective { verify reqCs19; }
44
+ subject verified : Base::Anything[*] = (propAlarmStopsSameStep, guaranteeAlarmStopsSameStep, tcAlarmLatency, gpcaDevice.gpcaSoftware.alarm);
28
45
  }
29
46
  verification vcTemporalModeSafety : VerificationCase {
30
47
  attribute :>> id = "VER-004";
31
48
  attribute :>> name = "VerifyTemporalModeSafety";
32
49
  attribute :>> methodKind = VerificationMethodKind::modelChecking;
33
50
  attribute :>> acceptanceCriteria = "No invalid transitions and pause on critical alarms";
34
- attribute :>> status = "planned";
51
+ attribute :>> status = ElementStatusKind::approved;
52
+
53
+ objective { verify reqCs75; verify reqDoorOpen; }
54
+ subject verified : Base::Anything[*] = (propLockoutTimerMonotonic, temporalNoInvalidTransition);
35
55
  }
36
56
  verification vcAirInLine : VerificationCase {
37
57
  attribute :>> id = "VER-005";
38
58
  attribute :>> name = "VerifyAirInLineStop";
39
59
  attribute :>> methodKind = VerificationMethodKind::test;
40
60
  attribute :>> acceptanceCriteria = "Injected air above threshold pauses infusion and annunciates per the REQ 59 High-priority actions (REQ-CS-21)";
41
- attribute :>> status = "planned";
61
+ attribute :>> status = ElementStatusKind::approved;
62
+
63
+ objective { verify reqCs21; }
64
+ subject verified : Base::Anything[*] = (airDetectionControl);
42
65
  }
43
66
  verification vcOcclusion : VerificationCase {
44
67
  attribute :>> id = "VER-006";
45
68
  attribute :>> name = "VerifyOcclusionDetection";
46
69
  attribute :>> methodKind = VerificationMethodKind::test;
47
70
  attribute :>> acceptanceCriteria = "Clamped line above pressure threshold pauses infusion and annunciates (REQ-X-04)";
48
- attribute :>> status = "planned";
71
+ attribute :>> status = ElementStatusKind::approved;
72
+
73
+ objective { verify reqOcclusion; }
74
+ subject verified : Base::Anything[*] = (occlusionAlarmControl);
49
75
  }
50
76
  verification vcEmptyReservoir : VerificationCase {
51
77
  attribute :>> id = "VER-007";
52
78
  attribute :>> name = "VerifyEmptyReservoirStop";
53
79
  attribute :>> methodKind = VerificationMethodKind::test;
54
80
  attribute :>> acceptanceCriteria = "Reservoir-empty assertion transitions to PAUSED (KVO flow) and annunciates per the REQ 59 High-priority actions (REQ-CS-23)";
55
- attribute :>> status = "planned";
81
+ attribute :>> status = ElementStatusKind::approved;
82
+
83
+ objective { verify reqCs23; }
84
+ subject verified : Base::Anything[*] = (reservoirMonitorControl, gpcaDevice.gpcaSoftware.systemStatus);
56
85
  }
57
86
  verification vcPost : VerificationCase {
58
87
  attribute :>> id = "VER-008";
59
88
  attribute :>> name = "VerifyPowerOnSelfTest";
60
89
  attribute :>> methodKind = VerificationMethodKind::test;
61
90
  attribute :>> acceptanceCriteria = "Each injected POST fault (CPU, RAM, ROM, watchdog, sensors) blocks therapy and alarms (REQ-X-02)";
62
- attribute :>> status = "planned";
91
+ attribute :>> status = ElementStatusKind::approved;
92
+
93
+ objective { verify reqPost; }
94
+ subject verified : Base::Anything[*] = (gpcaDevice.gpcaSoftware.systemMonitor);
63
95
  }
64
96
  verification vcPowerLoss : VerificationCase {
65
97
  attribute :>> id = "VER-009";
66
98
  attribute :>> name = "VerifyPowerLossRetentionAndResume";
67
99
  attribute :>> methodKind = VerificationMethodKind::test;
68
100
  attribute :>> acceptanceCriteria = "Prescription and log intact after power cycle; therapy resumes only after confirmation (REQ-X-03)";
69
- attribute :>> status = "planned";
101
+ attribute :>> status = ElementStatusKind::approved;
102
+
103
+ objective { verify reqPowerLossRetention; verify reqBatteryBackup; }
70
104
  }
71
105
  verification vcWatchdog : VerificationCase {
72
106
  attribute :>> id = "VER-010";
73
107
  attribute :>> name = "VerifyWatchdogSafeState";
74
108
  attribute :>> methodKind = VerificationMethodKind::test;
75
109
  attribute :>> acceptanceCriteria = "Induced CPU hang forces zero flow and continuous alarm within 60 ms (REQ-X-08, TC-003)";
76
- attribute :>> status = "planned";
110
+ attribute :>> status = ElementStatusKind::approved;
111
+
112
+ objective { verify reqWatchdogSafeState; }
113
+ subject verified : Base::Anything[*] = (watchdogControl, tcWatchdogTimeout);
77
114
  }
78
115
  verification vcHourlyMax : VerificationCase {
79
116
  attribute :>> id = "VER-011";
80
117
  attribute :>> name = "VerifyHourlyDoseCeiling";
81
118
  attribute :>> methodKind = VerificationMethodKind::simulation;
82
119
  attribute :>> acceptanceCriteria = "Randomized bolus/basal schedules never exceed hourly maximum in sliding window (REQ-X-06)";
83
- attribute :>> status = "planned";
120
+ attribute :>> status = ElementStatusKind::approved;
121
+
122
+ objective { verify reqMaxHourlyDose; }
84
123
  }
85
124
  verification vcPumpAccuracy : VerificationCase {
86
125
  attribute :>> id = "VER-012";
87
126
  attribute :>> name = "VerifyDeliveryAccuracy";
88
127
  attribute :>> methodKind = VerificationMethodKind::test;
89
128
  attribute :>> acceptanceCriteria = "Gravimetric bench measurement within ±5% (Tolerance_Min_const) across rate range (REQ-X-11)";
90
- attribute :>> status = "planned";
129
+ attribute :>> status = ElementStatusKind::approved;
130
+
131
+ objective { verify reqPumpAccuracy; }
91
132
  }
92
133
  verification vcAlarmLoudness : VerificationCase {
93
134
  attribute :>> id = "VER-013";
94
135
  attribute :>> name = "VerifyAlarmSoundPressure";
95
136
  attribute :>> methodKind = VerificationMethodKind::test;
96
137
  attribute :>> acceptanceCriteria = "Each priority tone meets Audio_level_const, 50 db for 2 s per I 8 (REQ-X-12)";
97
- attribute :>> status = "planned";
138
+ attribute :>> status = ElementStatusKind::approved;
139
+
140
+ objective { verify reqCs72; verify reqAlarmLoudness; }
98
141
  }
99
142
  verification vcFreeFlow : VerificationCase {
100
143
  attribute :>> id = "VER-014";
101
144
  attribute :>> name = "VerifyAntiFreeFlowValve";
102
145
  attribute :>> methodKind = VerificationMethodKind::test;
103
146
  attribute :>> acceptanceCriteria = "No gravity flow with set disengaged under worst-case head height (REQ-X-14)";
104
- attribute :>> status = "planned";
147
+ attribute :>> status = ElementStatusKind::approved;
148
+
149
+ objective { verify reqFreeFlowPrevention; }
150
+ subject verified : Base::Anything[*] = (freeFlowValveControl);
105
151
  }
106
152
  verification vcStuckButton : VerificationCase {
107
153
  attribute :>> id = "VER-015";
108
154
  attribute :>> name = "VerifyStuckButtonDetection";
109
155
  attribute :>> methodKind = VerificationMethodKind::test;
110
156
  attribute :>> acceptanceCriteria = "Shorted pendant input yields no bolus and Medium-priority notification after 60 s (REQ-X-09)";
111
- attribute :>> status = "planned";
157
+ attribute :>> status = ElementStatusKind::approved;
158
+
159
+ objective { verify reqStuckButton; }
112
160
  }
113
161
  verification vcFlowCrossCheck : VerificationCase {
114
162
  attribute :>> id = "VER-016";
115
163
  attribute :>> name = "VerifyFlowCrossCheck";
116
164
  attribute :>> methodKind = VerificationMethodKind::test;
117
165
  attribute :>> acceptanceCriteria = "Injected deviation beyond Tolerance_Min_const sustained past Max_Duration_OverInfusion_const pauses therapy and annunciates (REQ-X-10)";
118
- attribute :>> status = "planned";
166
+ attribute :>> status = ElementStatusKind::approved;
167
+
168
+ objective { verify reqFlowCrossCheck; }
169
+ subject verified : Base::Anything[*] = (flowCrossCheckControl);
119
170
  }
120
171
 
121
172
  verification vcDrugLibrary : VerificationCase {
@@ -123,56 +174,74 @@ package memo_examples_gpca_pump_gpca_verification {
123
174
  attribute :>> name = "VerifyDrugLibraryEnforcement";
124
175
  attribute :>> methodKind = VerificationMethodKind::test;
125
176
  attribute :>> acceptanceCriteria = "Hard-limit entries rejected, soft-limit entries require confirmation, both logged (REQ-X-01)";
126
- attribute :>> status = "planned";
177
+ attribute :>> status = ElementStatusKind::approved;
178
+
179
+ objective { verify reqDrugLibraryLimits; }
180
+ subject verified : Base::Anything[*] = (drugLibraryControl, gpcaDevice.gpcaSoftware.config);
127
181
  }
128
182
  verification vcPrescriptionConfirm : VerificationCase {
129
183
  attribute :>> id = "VER-018";
130
184
  attribute :>> name = "VerifyPrescriptionConfirmation";
131
185
  attribute :>> methodKind = VerificationMethodKind::demonstration;
132
186
  attribute :>> acceptanceCriteria = "Therapy cannot start without distinct confirmation; displayed values equal stored values (REQ-CS-09)";
133
- attribute :>> status = "planned";
187
+ attribute :>> status = ElementStatusKind::approved;
188
+
189
+ objective { verify reqCs09; }
134
190
  }
135
191
  verification vcEventLog : VerificationCase {
136
192
  attribute :>> id = "VER-019";
137
193
  attribute :>> name = "VerifyEventLogIntegrity";
138
194
  attribute :>> methodKind = VerificationMethodKind::test;
139
195
  attribute :>> acceptanceCriteria = "Operational/error log entries per REQ-CS-78..81; tampering detectable (REQ-X-07)";
140
- attribute :>> status = "planned";
196
+ attribute :>> status = ElementStatusKind::approved;
197
+
198
+ objective { verify reqCs78; verify reqEventLogging; }
199
+ subject verified : Base::Anything[*] = (gpcaDevice.gpcaSoftware.logging);
141
200
  }
142
201
  verification vcReverseDeliveryPause : VerificationCase {
143
202
  attribute :>> id = "VER-020";
144
203
  attribute :>> name = "VerifyReverseDeliveryPause";
145
204
  attribute :>> methodKind = VerificationMethodKind::modelChecking;
146
205
  attribute :>> acceptanceCriteria = "Continuous or cumulative reverse delivery beyond the REQ-CS-22 duration limits transitions to PAUSED and raises the Reverse Delivery notification (NOTIF-04)";
147
- attribute :>> status = "planned";
206
+ attribute :>> status = ElementStatusKind::approved;
207
+
208
+ subject verified : Base::Anything[*] = (reverseDeliveryPauseControl);
148
209
  }
149
210
  verification vcAntiRefluxMechanism : VerificationCase {
150
211
  attribute :>> id = "VER-021";
151
212
  attribute :>> name = "VerifyContinuousReverseDeliveryPrevention";
152
213
  attribute :>> methodKind = VerificationMethodKind::test;
153
214
  attribute :>> acceptanceCriteria = "During normal use and single fault condition, continuous reverse delivery is not possible (IEC 601-2-24 basis per GPCA safety requirements)";
154
- attribute :>> status = "planned";
215
+ attribute :>> status = ElementStatusKind::approved;
216
+
217
+ subject verified : Base::Anything[*] = (antiRefluxDesignControl);
155
218
  }
156
219
  verification vcVtbiCeiling : VerificationCase {
157
220
  attribute :>> id = "VER-022";
158
221
  attribute :>> name = "VerifyVtbiCeilingPause";
159
222
  attribute :>> methodKind = VerificationMethodKind::modelChecking;
160
223
  attribute :>> acceptanceCriteria = "Actual volume infused above the drug-database maximum VTBI transitions to PAUSED with flow at most KVO (REQ-CS-20, AGREE GP-008) and raises NOTIF-06";
161
- attribute :>> status = "planned";
224
+ attribute :>> status = ElementStatusKind::approved;
225
+
226
+ subject verified : Base::Anything[*] = (vtbiLimitPauseControl);
162
227
  }
163
228
  verification vcInfusionComplete : VerificationCase {
164
229
  attribute :>> id = "VER-023";
165
230
  attribute :>> name = "VerifyInfusionCompleteStop";
166
231
  attribute :>> methodKind = VerificationMethodKind::test;
167
232
  attribute :>> acceptanceCriteria = "Reaching prescribed total duration or maximum VTBI transitions ACTIVE to IDLE with Infusion Complete actions (REQ-CS-28)";
168
- attribute :>> status = "planned";
233
+ attribute :>> status = ElementStatusKind::approved;
234
+
235
+ subject verified : Base::Anything[*] = (infusionCompleteControl);
169
236
  }
170
237
  verification vcDoorInterlock : VerificationCase {
171
238
  attribute :>> id = "VER-024";
172
239
  attribute :>> name = "VerifyDoorOpenDeliveryInhibit";
173
240
  attribute :>> methodKind = VerificationMethodKind::test;
174
241
  attribute :>> acceptanceCriteria = "Door open during THERAPY limits flow to at most KVO and raises a notification (AGREE GP-011; REQ-X-05)";
175
- attribute :>> status = "planned";
242
+ attribute :>> status = ElementStatusKind::approved;
243
+
244
+ subject verified : Base::Anything[*] = (doorInterlockControl);
176
245
  }
177
246
 
178
247
  // ── Validation cases (design validation / IEC 62366) ────────
@@ -194,7 +263,8 @@ package memo_examples_gpca_pump_gpca_verification {
194
263
  }
195
264
 
196
265
  // ── Test artifacts and evidence ─────────────────────────────
197
- part testReportLockout : TestArtifact {
266
+ part testReportLockout : MemoEvidence {
267
+ attribute :>> evidenceKind = EvidenceKind::testArtifact;
198
268
  attribute :>> id = "TEST-001";
199
269
  attribute :>> name = "BolusLockoutTestReport";
200
270
  attribute :>> version = "0.1";
@@ -202,7 +272,8 @@ package memo_examples_gpca_pump_gpca_verification {
202
272
  attribute :>> artifactKind = ArtifactKind::testReport;
203
273
  attribute :>> resultSummary = "planned";
204
274
  }
205
- part testProtocolSafetySuite : TestArtifact {
275
+ part testProtocolSafetySuite : MemoEvidence {
276
+ attribute :>> evidenceKind = EvidenceKind::testArtifact;
206
277
  attribute :>> id = "TEST-002";
207
278
  attribute :>> name = "SafetyAlarmTestProtocol";
208
279
  attribute :>> version = "0.1";
@@ -210,7 +281,8 @@ package memo_examples_gpca_pump_gpca_verification {
210
281
  attribute :>> artifactKind = ArtifactKind::testProtocol;
211
282
  attribute :>> resultSummary = "covers VER-005..VER-010, VER-015, VER-016, VER-020, VER-022..VER-024";
212
283
  }
213
- part evidenceLockout : Evidence {
284
+ part evidenceLockout : MemoEvidence {
285
+ attribute :>> evidenceKind = EvidenceKind::evidence;
214
286
  attribute :>> id = "EVD-001";
215
287
  attribute :>> name = "BolusLockoutEvidence";
216
288
  attribute :>> version = "0.1";
@@ -218,7 +290,8 @@ package memo_examples_gpca_pump_gpca_verification {
218
290
  attribute :>> evidenceType = "verification evidence";
219
291
  attribute :>> integrityStatus = "draft";
220
292
  }
221
- part evidenceModeRange : Evidence {
293
+ part evidenceModeRange : MemoEvidence {
294
+ attribute :>> evidenceKind = EvidenceKind::evidence;
222
295
  attribute :>> id = "EVD-002";
223
296
  attribute :>> name = "ModeRangeEvidence";
224
297
  attribute :>> version = "0.1";
@@ -226,7 +299,8 @@ package memo_examples_gpca_pump_gpca_verification {
226
299
  attribute :>> evidenceType = "formal proof evidence";
227
300
  attribute :>> integrityStatus = "draft";
228
301
  }
229
- part evidenceSameStepAlarm : Evidence {
302
+ part evidenceSameStepAlarm : MemoEvidence {
303
+ attribute :>> evidenceKind = EvidenceKind::evidence;
230
304
  attribute :>> id = "EVD-003";
231
305
  attribute :>> name = "SameStepAlarmEvidence";
232
306
  attribute :>> version = "0.1";
@@ -234,7 +308,8 @@ package memo_examples_gpca_pump_gpca_verification {
234
308
  attribute :>> evidenceType = "model checking evidence";
235
309
  attribute :>> integrityStatus = "draft";
236
310
  }
237
- part evidenceTemporalModeSafety : Evidence {
311
+ part evidenceTemporalModeSafety : MemoEvidence {
312
+ attribute :>> evidenceKind = EvidenceKind::evidence;
238
313
  attribute :>> id = "EVD-004";
239
314
  attribute :>> name = "TemporalModeSafetyEvidence";
240
315
  attribute :>> version = "0.1";
@@ -242,7 +317,8 @@ package memo_examples_gpca_pump_gpca_verification {
242
317
  attribute :>> evidenceType = "model checking evidence";
243
318
  attribute :>> integrityStatus = "draft";
244
319
  }
245
- part evidenceSafetyAlarmSuite : Evidence {
320
+ part evidenceSafetyAlarmSuite : MemoEvidence {
321
+ attribute :>> evidenceKind = EvidenceKind::evidence;
246
322
  attribute :>> id = "EVD-005";
247
323
  attribute :>> name = "SafetyAlarmSuiteEvidence";
248
324
  attribute :>> version = "0.1";
@@ -250,7 +326,8 @@ package memo_examples_gpca_pump_gpca_verification {
250
326
  attribute :>> evidenceType = "bench test evidence for alarm-driven safe states";
251
327
  attribute :>> integrityStatus = "draft";
252
328
  }
253
- part evidenceUsability : Evidence {
329
+ part evidenceUsability : MemoEvidence {
330
+ attribute :>> evidenceKind = EvidenceKind::evidence;
254
331
  attribute :>> id = "EVD-006";
255
332
  attribute :>> name = "SummativeUsabilityEvidence";
256
333
  attribute :>> version = "0.1";
@@ -258,7 +335,8 @@ package memo_examples_gpca_pump_gpca_verification {
258
335
  attribute :>> evidenceType = "summative usability report per IEC 62366-1";
259
336
  attribute :>> integrityStatus = "draft";
260
337
  }
261
- part evidenceHardwareBench : Evidence {
338
+ part evidenceHardwareBench : MemoEvidence {
339
+ attribute :>> evidenceKind = EvidenceKind::evidence;
262
340
  attribute :>> id = "EVD-008";
263
341
  attribute :>> name = "HardwareBenchEvidence";
264
342
  attribute :>> version = "0.1";
@@ -266,7 +344,8 @@ package memo_examples_gpca_pump_gpca_verification {
266
344
  attribute :>> evidenceType = "bench evidence for alarm loudness and anti-free-flow valve";
267
345
  attribute :>> integrityStatus = "draft";
268
346
  }
269
- part evidenceDoseProgramming : Evidence {
347
+ part evidenceDoseProgramming : MemoEvidence {
348
+ attribute :>> evidenceKind = EvidenceKind::evidence;
270
349
  attribute :>> id = "EVD-009";
271
350
  attribute :>> name = "DoseProgrammingEvidence";
272
351
  attribute :>> version = "0.1";
@@ -274,7 +353,8 @@ package memo_examples_gpca_pump_gpca_verification {
274
353
  attribute :>> evidenceType = "test evidence for prescription limits, confirmation, dose ceiling, and event log";
275
354
  attribute :>> integrityStatus = "draft";
276
355
  }
277
- part evidenceDeliveryAccuracy : Evidence {
356
+ part evidenceDeliveryAccuracy : MemoEvidence {
357
+ attribute :>> evidenceKind = EvidenceKind::evidence;
278
358
  attribute :>> id = "EVD-007";
279
359
  attribute :>> name = "DeliveryAccuracyEvidence";
280
360
  attribute :>> version = "0.1";
@@ -17,5 +17,10 @@ package memo_examples_gpca_pump_project {
17
17
  ref :>> selectedMethodology = gpcaMethodDefinition;
18
18
  // The project adds nothing to the methodology's selection.
19
19
  attribute :>> scopeMode = ScopeModeKind::explicit;
20
+ // The submission regimes this device targets. `memo standards check`
21
+ // reads this to decide which standards are required: an EU + US launch
22
+ // pulls in both the harmonised IEC/ISO packs and 21 CFR Part 820,
23
+ // where a CE-only project would not be asked for the FDA clauses.
24
+ attribute :>> regulatoryRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::FDA_510k);
20
25
  }
21
26
  }
@@ -18,7 +18,6 @@ package memo_examples_gpca_pump_viewpoints_context_views_context_system_context_
18
18
  attribute depth = 2;
19
19
  attribute :>> id = "VIEW-CTX-101";
20
20
  attribute :>> name = "GPCA_SystemContextView";
21
- attribute :>> title = "GPCA System Context View";
22
21
  attribute :>> shortDescription = "Actors, use contexts, and external entities at the GPCA system boundary.";
23
22
  attribute :>> description = "Shows the CriSys Fig 2.1 boundary: patient, clinician, prescription, drug reservoir, needle, hospital pharmacy database, and hospital environment around the pump, with directional data flows, physical drug-path connections, and the intended use anchoring the boundary.";
24
23
  attribute :>> outputKind = (ViewOutputKind::diagram);
@@ -28,16 +27,15 @@ package memo_examples_gpca_pump_viewpoints_context_views_context_system_context_
28
27
  attribute :>> dataSourceDescription = "GPCA context layer: actors, use contexts, intended use, operational entities";
29
28
  attribute :>> autoPopulate = true;
30
29
  attribute :>> queryDescription = "Include actors, use contexts, intended use, and external operational entities.";
31
- attribute :>> documentUsage = ("Architecture Description", "Usability Engineering File");
32
30
  part :>> selectionQuery {
33
31
  attribute :>> id = "QRY-CTX-101";
34
32
  attribute :>> name = "GPCA_SystemContextQuery";
35
33
  attribute :>> includeElementKinds = ("Actor", "UseContext", "IntendedUse", "ReasonablyForeseeableMisuse", "OperationalEntity");
36
- attribute :>> includeRelationshipKinds = ("InteractsWith", "ExchangesWith", "ConnectsPhysically", "Governs", "AppliesInContext");
34
+ attribute :>> includeRelationshipKinds = ("InteractsWith", "flow", "connect", "Governs", "AppliesInContext");
37
35
  attribute :>> includeLayers = ("context", "operational");
38
36
  attribute :>> selectionExpression = "product == 'GPCA'";
39
37
  attribute :>> rationaleText = "Auto-populate the GPCA context view from the context layer.";
40
38
  }
41
- part :>> viewpointDefinition = contextViewpoint;
39
+ ref :>> viewpointDefinition = contextViewpoint;
42
40
  }
43
41
  }
@@ -19,7 +19,6 @@ package memo_examples_gpca_pump_viewpoints_cybersecurity_views_cybersecurity_cyb
19
19
  attribute depth = 2;
20
20
  attribute :>> id = "VIEW-CYB-001";
21
21
  attribute :>> name = "GPCA_CybersecurityView";
22
- attribute :>> title = "GPCA Cybersecurity View";
23
22
  attribute :>> shortDescription = "Shows GPCA assets, trust boundaries, threats, vulnerabilities, and mitigations.";
24
23
  attribute :>> description = "Product-specific cybersecurity view intended for secure product development and cross-reference into cybersecurity risk documentation.";
25
24
  attribute :>> outputKind = (ViewOutputKind::diagram);
@@ -29,16 +28,15 @@ package memo_examples_gpca_pump_viewpoints_cybersecurity_views_cybersecurity_cyb
29
28
  attribute :>> dataSourceDescription = "GPCA cyber assets, threat scenarios, and trace links";
30
29
  attribute :>> autoPopulate = true;
31
30
  attribute :>> queryDescription = "Include cyber assets, trust boundaries, threats, vulnerabilities, cyber hazards, cyber risks, mitigations, security requirements, and verification.";
32
- attribute :>> documentUsage = ("Threat Model", "Cybersecurity Risk Assessment", "QMSR");
33
31
  part :>> selectionQuery {
34
32
  attribute :>> id = "QRY-CYB-001";
35
33
  attribute :>> name = "GPCA_CybersecurityQuery";
36
- attribute :>> includeElementKinds = ("CybersecurityAsset", "Threat", "Vulnerability", "CyberHazard", "CyberRisk", "CyberMitigation", "SecurityRequirement", "TrustBoundary", "ThreatScenario");
34
+ attribute :>> includeElementKinds = ("CybersecurityAsset", "Threat", "Vulnerability", "CyberHazard", "CyberRisk", "CyberMitigation", "SecurityRequirement", "TrustBoundary", "OperativeScenario[scenarioKind=threat]");
37
35
  attribute :>> includeLayers = ("cybersecurity", "risk", "assurance");
38
36
  attribute :>> includeConcerns = (ConcernKind::cybersecurity, ConcernKind::privacy, ConcernKind::safety);
39
37
  attribute :>> selectionExpression = "product == 'GPCA'";
40
38
  attribute :>> rationaleText = "Auto-populate the GPCA cybersecurity view from the cyber layer and cross-layer trace model.";
41
39
  }
42
- part :>> viewpointDefinition = cybersecurityViewpoint;
40
+ ref :>> viewpointDefinition = cybersecurityViewpoint;
43
41
  }
44
42
  }
@@ -10,15 +10,12 @@ package memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_cyber_as
10
10
  expose memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_cyber_assessment_view::*;
11
11
  attribute :>> id = "DOC-003";
12
12
  attribute :>> name = "GPCAMemoCybersecurityAssessmentView";
13
- attribute :>> title = "GPCA Cybersecurity Assessment View";
14
13
  attribute :>> shortDescription = "Cybersecurity risk-assessment-oriented document view for GPCA.";
15
14
  attribute :>> description = "Captures GPCA cyber risks, mitigations, security requirements, verification, and safety/privacy traceability for cybersecurity assessment records.";
16
15
  attribute :>> version = "0.1";
17
16
  attribute :>> lifecycleState = LifecycleStateKind::development;
18
17
  attribute :>> marketScope = "generic";
19
- attribute :>> documentUsage = ("Cybersecurity Risk Assessment", "RMF", "QMSR");
20
- attribute :>> sectionIdentifier = "CYB-RA";
21
- part :>> viewpointDefinition = cybersecurityViewpoint;
18
+ ref :>> viewpointDefinition = cybersecurityViewpoint;
22
19
  part :>> selectionQuery {
23
20
  attribute :>> id = "QRY-DOC-009";
24
21
  attribute :>> name = "cyberAssessmentViewQuery";
@@ -10,19 +10,16 @@ package memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_threat_m
10
10
  expose memo_examples_gpca_pump_viewpoints_cybersecurity_views_document_threat_model_view::*;
11
11
  attribute :>> id = "DOC-002";
12
12
  attribute :>> name = "GPCACyberThreatModelView";
13
- attribute :>> title = "GPCA Cybersecurity Threat Model View";
14
13
  attribute :>> shortDescription = "Threat-model-oriented document view for GPCA.";
15
14
  attribute :>> description = "Captures GPCA cyber assets, trust boundaries, threats, threat scenarios, vulnerabilities, and mitigations for secure product development records.";
16
15
  attribute :>> version = "0.1";
17
16
  attribute :>> lifecycleState = LifecycleStateKind::development;
18
17
  attribute :>> marketScope = "generic";
19
- attribute :>> documentUsage = ("Threat Model", "QMSR");
20
- attribute :>> sectionIdentifier = "CYB-TM";
21
- part :>> viewpointDefinition = cybersecurityViewpoint;
18
+ ref :>> viewpointDefinition = cybersecurityViewpoint;
22
19
  part :>> selectionQuery {
23
20
  attribute :>> id = "QRY-DOC-008";
24
21
  attribute :>> name = "threatModelViewQuery";
25
- attribute :>> includeElementKinds = ("Threat", "ThreatScenario", "Vulnerability", "CybersecurityAsset", "TrustBoundary", "AttackSurface", "CyberMitigation", "SecurityRequirement");
22
+ attribute :>> includeElementKinds = ("Threat", "OperativeScenario[scenarioKind=threat]", "Vulnerability", "CybersecurityAsset", "TrustBoundary", "AttackSurface", "CyberMitigation", "SecurityRequirement");
26
23
  attribute :>> includeRelationshipKinds = ("ThreatenedBy", "Exploits", "RealizedByScenario", "CrossesTrustBoundary", "Mitigates", "DerivesCyberRequirement");
27
24
  attribute :>> rationaleText = "Declares what this document-backed view renders; the web renderer is presentation-only.";
28
25
  }
@@ -18,7 +18,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
18
18
  attribute depth = 2;
19
19
  attribute :>> id = "VIEW-FUN-102";
20
20
  attribute :>> name = "GPCA_FunctionAllocationView";
21
- attribute :>> title = "GPCA Function Allocation View";
22
21
  attribute :>> shortDescription = "Allocation of logical functions to software components and hardware assemblies.";
23
22
  attribute :>> outputKind = (ViewOutputKind::matrix);
24
23
  attribute :>> presentationKind = (PresentationKind::traceMatrix);
@@ -27,7 +26,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
27
26
  attribute :>> dataSourceDescription = "AllocatedTo links between functions and architecture elements";
28
27
  attribute :>> autoPopulate = true;
29
28
  attribute :>> queryDescription = "Include logical functions with their AllocatedTo targets.";
30
- attribute :>> documentUsage = ("SDD", "Architecture Description");
31
29
  part :>> selectionQuery {
32
30
  attribute :>> id = "QRY-FUN-102";
33
31
  attribute :>> name = "GPCA_FunctionAllocationQuery";
@@ -37,6 +35,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
37
35
  attribute :>> selectionExpression = "product == 'GPCA'";
38
36
  attribute :>> rationaleText = "Show complete function-to-component allocation coverage.";
39
37
  }
40
- part :>> viewpointDefinition = functionalViewpoint;
38
+ ref :>> viewpointDefinition = functionalViewpoint;
41
39
  }
42
40
  }
@@ -18,7 +18,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
18
18
  attribute depth = 2;
19
19
  attribute :>> id = "VIEW-FUN-103";
20
20
  attribute :>> name = "GPCA_FunctionBrowserView";
21
- attribute :>> title = "GPCA Function Browser";
22
21
  attribute :>> shortDescription = "Membership tree over the functions layer: logical functions, flows, and the exchange item definitions, grouped by kind.";
23
22
  attribute :>> description = "Browser view (SysML v2 browser view kind) exposing the functions-layer membership hierarchy as a first-class view: the eleven logical functions, the logical flows connecting them, and the data/control definitions they exchange — with kind icons, expand/collapse, and filtering.";
24
23
  attribute :>> outputKind = (ViewOutputKind::diagram);
@@ -27,7 +26,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
27
26
  attribute :>> dataSourceDescription = "GPCA logical functions, flows, and exchange item definitions";
28
27
  attribute :>> autoPopulate = true;
29
28
  attribute :>> queryDescription = "Include the functions layer's functions, flows, and exchange item definitions.";
30
- attribute :>> documentUsage = ("SDD");
31
29
  part :>> selectionQuery {
32
30
  attribute :>> id = "QRY-FUN-103";
33
31
  attribute :>> name = "GPCA_FunctionBrowserQuery";
@@ -36,6 +34,6 @@ package memo_examples_gpca_pump_viewpoints_functional_views_functional_function_
36
34
  attribute :>> selectionExpression = "product == 'GPCA'";
37
35
  attribute :>> rationaleText = "Auto-populate the function browser from the functions layer.";
38
36
  }
39
- part :>> viewpointDefinition = functionalViewpoint;
37
+ ref :>> viewpointDefinition = functionalViewpoint;
40
38
  }
41
39
  }
@@ -18,7 +18,6 @@ package memo_examples_gpca_pump_viewpoints_logical_views_behavior_action_flow_vi
18
18
  attribute depth = 2;
19
19
  attribute :>> id = "VIEW-BHV-003";
20
20
  attribute :>> name = "GPCA_InfusionDeliveryActionFlowView";
21
- attribute :>> title = "GPCA Infusion Delivery Action Flow";
22
21
  attribute :>> shortDescription = "The 20 ms execution-step pipeline from sensor acquisition through alarm evaluation and dose limiting to pump actuation and event logging.";
23
22
  attribute :>> description = "Action flow over the infusionDeliveryFlow composite action: typed action steps with in/out parameters, item flows carrying the DD/CD exchange items, succession ordering from start to done, and swimlane allocation onto the logical architecture (sensors, alarm, infusion manager, pump motor, logging).";
24
23
  attribute :>> outputKind = (ViewOutputKind::diagram);
@@ -28,7 +27,6 @@ package memo_examples_gpca_pump_viewpoints_logical_views_behavior_action_flow_vi
28
27
  attribute :>> dataSourceDescription = "GPCA infusion delivery composite action, item flows, and successions";
29
28
  attribute :>> autoPopulate = true;
30
29
  attribute :>> queryDescription = "Include the nested action usages of the infusion delivery flow with their flows and successions.";
31
- attribute :>> documentUsage = ("SDD");
32
30
  part :>> selectionQuery {
33
31
  attribute :>> id = "QRY-BHV-103";
34
32
  attribute :>> name = "GPCA_ActionFlowQuery";
@@ -36,6 +34,6 @@ package memo_examples_gpca_pump_viewpoints_logical_views_behavior_action_flow_vi
36
34
  attribute :>> selectionExpression = "product == 'GPCA'";
37
35
  attribute :>> rationaleText = "Auto-populate the action flow view from the behavior layer's action usages.";
38
36
  }
39
- part :>> viewpointDefinition = logicalArchitectureViewpoint;
37
+ ref :>> viewpointDefinition = logicalArchitectureViewpoint;
40
38
  }
41
39
  }
@@ -11,7 +11,6 @@ package memo_examples_gpca_pump_viewpoints_logical_views_document_architecture_d
11
11
  expose memo_examples_gpca_pump_viewpoints_logical_views_document_architecture_description_view::*;
12
12
  attribute :>> id = "DOC-005";
13
13
  attribute :>> name = "ArchitectureDescriptionView";
14
- attribute :>> title = "GPCA System Architecture Description View";
15
14
  attribute :>> shortDescription = "ISO/IEC/IEEE 42010 architecture description across all layers.";
16
15
  attribute :>> description = "Aggregates context, operational, functional, logical, software, and physical layers with their views and correspondences for the system architecture description.";
17
16
  attribute :>> version = "0.1";
@@ -19,16 +18,14 @@ package memo_examples_gpca_pump_viewpoints_logical_views_document_architecture_d
19
18
  attribute :>> viewKind = DocumentViewKind::architectureDescription;
20
19
  attribute :>> generationRule = "Include all architecture layers, functional chains, interfaces, and the physical BOM with cross-layer allocations";
21
20
  attribute :>> marketScope = "generic";
22
- attribute :>> documentUsage = ("Architecture Description", "DHF");
23
- attribute :>> sectionIdentifier = "AD";
24
- part vpLogicalArchitecture :> viewpointDefinition = logicalArchitectureViewpoint;
25
- part vpSoftware :> viewpointDefinition = softwareViewpoint;
26
- part vpPhysical :> viewpointDefinition = physicalViewpoint;
21
+ ref vpLogicalArchitecture :> viewpointDefinition = logicalArchitectureViewpoint;
22
+ ref vpSoftware :> viewpointDefinition = softwareViewpoint;
23
+ ref vpPhysical :> viewpointDefinition = physicalViewpoint;
27
24
  part :>> selectionQuery {
28
25
  attribute :>> id = "QRY-DOC-005";
29
26
  attribute :>> name = "architectureDescriptionViewQuery";
30
27
  attribute :>> includeElementKinds = ("LogicalComponent", "SystemFunction", "ComponentExchange", "SoftwareSystem", "SoftwareModule", "HardwareAssembly", "ProcessingNode", "PhysicalPort", "FunctionalFlow", "FunctionalFlowStep");
31
- attribute :>> includeRelationshipKinds = ("Composes", "AllocatedTo", "Realizes", "BindsToInterface", "InvolvesFunction", "Precedes", "DeploysTo", "HostedBy");
28
+ attribute :>> includeRelationshipKinds = ("Composes", "AllocatedTo", "Realizes", "BindsToInterface", "Performs", "Succession", "DeploysTo", "HostedBy");
32
29
  attribute :>> rationaleText = "Declares what this document-backed view renders; the web renderer is presentation-only.";
33
30
  }
34
31
  }
@@ -18,26 +18,24 @@ package memo_examples_gpca_pump_viewpoints_logical_views_logical_device_intercon
18
18
  attribute depth = 2;
19
19
  attribute :>> id = "VIEW-LOG-003";
20
20
  attribute :>> name = "GPCA_DeviceInterconnectView";
21
- attribute :>> title = "GPCA Device Interconnect View";
22
21
  attribute :>> shortDescription = "AADL device-level interconnection: GPCA_HW_Sensors, GPCA_SW, and GPCA_HW_Actuators with their declared boundary features.";
23
22
  attribute :>> description = "Source-faithful interconnection view of GPCA_Device.Impl: exactly the three AADL subcomponents (GPCA_HW_Sensors, GPCA_SW, GPCA_HW_Actuators), the device and subsystem boundary ports, and the twelve declared port connections. MEMO physical-design additions such as the controller board, power sources, enclosure, and individual sensors/actuators are intentionally excluded because the published AADL v2.0 model does not declare them as GPCA_Device.Impl subcomponents. Drill into GPCA_SW to inspect its eight subcomponents and 42 internal connections; use the connection-density control to switch between bundled summary and full fidelity.";
24
23
  attribute :>> outputKind = (ViewOutputKind::diagram);
25
24
  attribute :>> presentationKind = (PresentationKind::internalDiagram);
26
25
  attribute :>> viewKind = DiagramViewKind::interconnection;
27
26
  attribute :>> diagramType = "ibd";
28
- attribute :>> dataSourceDescription = "GPCA hardware assemblies, software system, software components, boundary ports, and the ExchangesWith/Composes topology";
27
+ attribute :>> dataSourceDescription = "GPCA hardware assemblies, software system, software components, boundary ports, and the flow/bind/Composes topology";
29
28
  attribute :>> autoPopulate = true;
30
29
  attribute :>> queryDescription = "Include hardware assemblies, the software system with its components and boundary ports, and the exchange topology between them.";
31
- attribute :>> documentUsage = ("SDD", "Architecture Description", "QMSR");
32
30
  part :>> selectionQuery {
33
31
  attribute :>> id = "QRY-LOG-003";
34
32
  attribute :>> name = "GPCA_DeviceInterconnectQuery";
35
33
  attribute :>> includeElementIds = ("gpcaDevice", "gpcaDeviceSensors", "gpcaSoftware", "gpcaActuators", "devOpCmdIn", "devDbIn", "devPresIn", "devPatientIn", "devGpcaOut", "snsOpCmdIn", "snsDbIn", "snsPresIn", "snsPatientIn", "snsOpCmdOut", "snsPresOut", "snsPatientOut", "snsSensorOut", "snsConstOut", "snsDbOut", "portOpCmdIn", "portPresIn", "portPatientIn", "portSensorIn", "portConstIn", "portDbIn", "portGpcaSwOut", "actGpcaSwIn", "actGpcaOut", "tlm", "systemStatus", "alarm", "config", "infusionMgr", "systemMonitor", "logging", "outputBus");
36
- attribute :>> includeRelationshipKinds = ("ExchangesWith", "Composes");
34
+ attribute :>> includeRelationshipKinds = ("flow", "bind", "Composes");
37
35
  attribute :>> includeLayers = ("logical_structure", "software_structure", "interfaces");
38
36
  attribute :>> selectionExpression = "product == 'GPCA'";
39
37
  attribute :>> rationaleText = "Render the device interconnect: parts with boundary ports as nodes, AADL connections as typed connectors, composition as nesting.";
40
38
  }
41
- part :>> viewpointDefinition = logicalArchitectureViewpoint;
39
+ ref :>> viewpointDefinition = logicalArchitectureViewpoint;
42
40
  }
43
41
  }