@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.
Files changed (394) hide show
  1. package/README.md +4 -2
  2. package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +1 -1
  3. package/examples/connected-patient-monitor/model/catalog/project.sysml +24 -0
  4. package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  5. package/examples/connected-patient-monitor/model/{viewpoints → catalog/viewpoints/unassigned/views}/connected_patient_monitor_overview.sysml +1 -1
  6. package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +7 -5
  7. package/examples/embedded-infusion-pump/model/catalog/project.sysml +24 -0
  8. package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  9. package/examples/embedded-infusion-pump/model/{viewpoints → catalog/viewpoints/unassigned/views}/embedded_infusion_pump_overview.sysml +1 -1
  10. package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +5 -5
  11. package/examples/functional-logical-physical/model/catalog/project.sysml +24 -0
  12. package/examples/functional-logical-physical/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  13. package/examples/functional-logical-physical/model/{viewpoints → catalog/viewpoints/unassigned/views}/functional_logical_physical_overview.sysml +1 -1
  14. package/examples/gpca-pump/methodology/gpca_methodology.sysml +7 -8
  15. package/examples/gpca-pump/methodology/gpca_profiles.sysml +89 -11
  16. package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +19 -9
  17. package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +342 -100
  18. package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +27 -13
  19. package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +329 -272
  20. package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +57 -16
  21. package/examples/gpca-pump/model/catalog/gpca_context.sysml +12 -8
  22. package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +14 -10
  23. package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +1 -15
  24. package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +181 -264
  25. package/examples/gpca-pump/model/catalog/gpca_operational.sysml +95 -60
  26. package/examples/gpca-pump/model/catalog/gpca_physical.sysml +6 -11
  27. package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +102 -101
  28. package/examples/gpca-pump/model/catalog/gpca_risk.sysml +1 -1
  29. package/examples/gpca-pump/model/catalog/gpca_standards.sysml +161 -0
  30. package/examples/gpca-pump/model/catalog/gpca_system.sysml +47 -30
  31. package/examples/gpca-pump/model/catalog/gpca_trace.sysml +301 -354
  32. package/examples/gpca-pump/model/catalog/gpca_verification.sysml +116 -36
  33. package/examples/gpca-pump/model/catalog/project.sysml +26 -0
  34. package/examples/gpca-pump/model/catalog/viewpoints/context/viewpoint.sysml +8 -0
  35. package/examples/gpca-pump/model/{views → catalog/viewpoints/context/views}/context_system_context_view.sysml +4 -4
  36. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/viewpoint.sysml +8 -0
  37. package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/cybersecurity_cybersecurity_view.sysml +4 -4
  38. package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_cyber_assessment_view.sysml +4 -4
  39. package/examples/gpca-pump/model/{views → catalog/viewpoints/cybersecurity/views}/document_threat_model_view.sysml +5 -5
  40. package/examples/gpca-pump/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
  41. package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_allocation_view.sysml +2 -2
  42. package/examples/gpca-pump/model/{views → catalog/viewpoints/functional/views}/functional_function_browser_view.sysml +3 -3
  43. package/examples/gpca-pump/model/catalog/viewpoints/logical/viewpoint.sysml +8 -0
  44. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/behavior_action_flow_view.sysml +3 -3
  45. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/document_architecture_description_view.sysml +8 -8
  46. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_device_interconnect_view.sysml +5 -5
  47. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_logical_architecture_view.sysml +3 -3
  48. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_mode_state_view.sysml +4 -4
  49. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_system_decomposition_view.sysml +3 -3
  50. package/examples/gpca-pump/model/catalog/viewpoints/operational/viewpoint.sysml +8 -0
  51. package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_scenario_sequence_view.sysml +3 -3
  52. package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_use_case_view.sysml +4 -4
  53. package/examples/gpca-pump/model/catalog/viewpoints/physical/viewpoint.sysml +8 -0
  54. package/examples/gpca-pump/model/{views → catalog/viewpoints/physical/views}/physical_physical_bom_view.sysml +2 -2
  55. package/examples/gpca-pump/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
  56. package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/document_dhf_index_view.sysml +8 -8
  57. package/examples/gpca-pump/model/{views → catalog/viewpoints/requirements/views}/requirements_requirements_trace_view.sysml +2 -2
  58. package/examples/gpca-pump/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
  59. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_hazard_analysis_view.sysml +8 -5
  60. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_rmf_view.sysml +7 -5
  61. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_fmea_view.sysml +3 -3
  62. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_risk_chain_view.sysml +3 -3
  63. package/examples/gpca-pump/model/catalog/viewpoints/software/viewpoint.sysml +8 -0
  64. package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/document_sdd_view.sysml +4 -4
  65. package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/software_software_architecture_view.sysml +5 -5
  66. package/examples/gpca-pump/model/catalog/viewpoints/usability/viewpoint.sysml +8 -0
  67. package/examples/gpca-pump/model/{views → catalog/viewpoints/usability/views}/document_usability_view.sysml +8 -6
  68. package/examples/gpca-pump/model/catalog/viewpoints/verification/viewpoint.sysml +8 -0
  69. package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/document_vv_view.sysml +7 -5
  70. package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/verification_verification_coverage_view.sysml +3 -3
  71. package/examples/ivd-laboratory-system/model/catalog/project.sysml +24 -0
  72. package/examples/ivd-laboratory-system/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  73. package/examples/ivd-laboratory-system/model/{viewpoints → catalog/viewpoints/unassigned/views}/ivd_laboratory_system_overview.sysml +1 -1
  74. package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +4 -2
  75. package/examples/manual-surgical-instrument/model/catalog/project.sysml +24 -0
  76. package/examples/manual-surgical-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  77. package/examples/manual-surgical-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/manual_surgical_instrument_overview.sysml +1 -1
  78. package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -2
  79. package/examples/multidimensional-layers/model/catalog/project.sysml +24 -0
  80. package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  81. package/examples/multidimensional-layers/model/{viewpoints → catalog/viewpoints/unassigned/views}/multidimensional_layers_overview.sysml +1 -1
  82. package/examples/nested-architecture-dsm/README.md +49 -0
  83. package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +179 -0
  84. package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +165 -0
  85. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +53 -0
  86. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +89 -0
  87. package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +113 -0
  88. package/examples/nested-architecture-dsm/model/catalog/project.sysml +28 -0
  89. package/examples/nested-architecture-dsm/model/catalog/traces.sysml +48 -0
  90. package/examples/reusable-instrument/model/catalog/project.sysml +24 -0
  91. package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +11 -8
  92. package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  93. package/examples/reusable-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/reusable_instrument_overview.sysml +1 -1
  94. package/examples/ros-mobile-robot/README.md +40 -0
  95. package/examples/ros-mobile-robot/model/catalog/project.sysml +33 -0
  96. package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +296 -0
  97. package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +7 -0
  98. package/examples/ros-mobile-robot/model/catalog/viewpoints/unassigned/views/ros_mobile_robot_overview.sysml +13 -0
  99. package/examples/software-only-medical-device/model/catalog/project.sysml +28 -0
  100. package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +11 -5
  101. package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  102. package/examples/software-only-medical-device/model/{viewpoints → catalog/viewpoints/unassigned/views}/software_only_medical_device_overview.sysml +1 -1
  103. package/examples/surgical-closure-workflow/model/catalog/project.sysml +24 -0
  104. package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +57 -57
  105. package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  106. package/examples/surgical-closure-workflow/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_closure_workflow_overview.sysml +1 -1
  107. package/examples/surgical-robot/model/catalog/project.sysml +24 -0
  108. package/examples/surgical-robot/model/catalog/surgical_robot.sysml +6 -4
  109. package/examples/surgical-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  110. package/examples/surgical-robot/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_robot_overview.sysml +1 -1
  111. package/examples/sysml-diagram-samples/README.md +7 -0
  112. package/examples/sysml-diagram-samples/dhf/documents/DOC-HAR-001.md +11 -0
  113. package/examples/sysml-diagram-samples/memo.package.yaml +11 -5
  114. package/examples/sysml-diagram-samples/model/catalog/project.sysml +33 -0
  115. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  116. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/action_flow_view.sysml +23 -20
  117. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/context_view.sysml +11 -11
  118. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.viewlayout +47 -0
  119. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +143 -0
  120. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +87 -0
  121. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.viewlayout +94 -0
  122. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +109 -0
  123. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.viewlayout +13 -0
  124. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/requirements_view.sysml +6 -7
  125. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +33 -0
  126. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +80 -0
  127. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +48 -0
  128. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/use_case_view.sysml +15 -9
  129. package/examples/sysml-diagram-samples/model/sysml_v2_activity_example.sysml +93 -0
  130. package/examples/temperature-alarm/model/catalog/project.sysml +24 -0
  131. package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +29 -21
  132. package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  133. package/examples/temperature-alarm/model/{viewpoints → catalog/viewpoints/unassigned/views}/temperature_alarm_overview.sysml +1 -1
  134. package/examples/ui-screen-regions/README.md +117 -0
  135. package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +84 -0
  136. package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +212 -0
  137. package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +61 -0
  138. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/drugSelectorRegion/drug-selector-expanded-2.4.1.png +0 -0
  139. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/mainScreenLayout/main-screen-2.4.1.png +0 -0
  140. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/settingsScreenLayout/settings-screen-2.4.1.png +0 -0
  141. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +51 -0
  142. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +27 -0
  143. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +27 -0
  144. package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +59 -0
  145. package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +25 -0
  146. package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +178 -0
  147. package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +93 -0
  148. package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +75 -0
  149. package/examples/ui-screen-regions/model/catalog/project.sysml +45 -0
  150. package/examples/ui-screen-regions/model/catalog/relationships.sysml +8 -0
  151. package/examples/ui-screen-regions/model/catalog/traces.sysml +179 -0
  152. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
  153. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +62 -0
  154. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
  155. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +62 -0
  156. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
  157. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +62 -0
  158. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/viewpoint.sysml +8 -0
  159. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +57 -0
  160. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +52 -0
  161. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +54 -0
  162. package/extensions/LICENSES/MIT.txt +19 -0
  163. package/extensions/README.md +94 -0
  164. package/extensions/aadl/memo.package.yaml +18 -0
  165. package/extensions/aadl/src/aadl_extension.sysml +6 -0
  166. package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +147 -0
  167. package/extensions/aadl/src/methodology/aadl_methodology.sysml +17 -0
  168. package/extensions/aadl/src/runtime/memo_aadl_runtime.sysml +56 -0
  169. package/extensions/clinical/memo.package.yaml +18 -0
  170. package/extensions/clinical/src/methodology/clinical_methodology.sysml +22 -0
  171. package/extensions/cloud/memo.package.yaml +18 -0
  172. package/extensions/cloud/src/cloud_extension.sysml +44 -0
  173. package/extensions/cloud/src/methodology/cloud_methodology.sysml +17 -0
  174. package/extensions/container/memo.package.yaml +18 -0
  175. package/extensions/container/src/container_extension.sysml +37 -0
  176. package/extensions/container/src/methodology/container_methodology.sysml +17 -0
  177. package/extensions/messaging/memo.package.yaml +18 -0
  178. package/extensions/messaging/src/messaging_extension.sysml +64 -0
  179. package/extensions/messaging/src/methodology/messaging_methodology.sysml +17 -0
  180. package/extensions/ros/memo.package.yaml +18 -0
  181. package/extensions/ros/src/methodology/ros_methodology.sysml +25 -0
  182. package/extensions/ros/src/ros_extension.sysml +200 -0
  183. package/extensions/template/memo.package.yaml +17 -0
  184. package/extensions/template/src/extension.sysml +37 -0
  185. package/memo.manifest.yaml +15 -2
  186. package/methodologies/default/memo.package.yaml +19 -9
  187. package/methodologies/gpca/memo.package.yaml +18 -9
  188. package/ontology/memo.package.yaml +23 -8
  189. package/package.json +6 -6
  190. package/profile/memo.package.yaml +18 -9
  191. package/src/architecture/decisions/memo_decisions.sysml +28 -0
  192. package/src/architecture/functional/behavior/memo_behavior.sysml +50 -22
  193. package/src/architecture/functional/constraints/memo_constraints.sysml +3 -2
  194. package/src/architecture/functional/functions/memo_functions.sysml +93 -43
  195. package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +46 -24
  196. package/src/architecture/implementation/software/structure/memo_software_structure.sysml +52 -12
  197. package/src/architecture/implementation/ui/memo_ui.sysml +276 -53
  198. package/src/architecture/logical/interfaces/memo_interfaces.sysml +64 -13
  199. package/src/architecture/logical/structure/memo_logical_structure.sysml +92 -35
  200. package/src/architecture/operational/activities/memo_activities.sysml +10 -4
  201. package/src/architecture/operational/context/actors/memo_actors.sysml +5 -8
  202. package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +13 -30
  203. package/src/architecture/operational/context/use_context/memo_use_context.sysml +42 -16
  204. package/src/architecture/operational/scenarios/memo_scenarios.sysml +57 -23
  205. package/src/architecture/operational/use_cases/memo_use_cases.sysml +35 -26
  206. package/src/architecture/operational/workflows/memo_workflows.sysml +28 -15
  207. package/src/architecture/realization/deployment/memo_deployment.sysml +111 -16
  208. package/src/architecture/realization/physical/memo_physical_architecture.sysml +27 -2
  209. package/src/artifacts/configuration_management/memo_configuration_management.sysml +35 -0
  210. package/src/artifacts/core/memo_controlled_artifacts.sysml +35 -0
  211. package/src/artifacts/documents/risk_management/memo_risk_management.sysml +12 -0
  212. package/src/artifacts/standards/cfr_21_820.sysml +116 -0
  213. package/src/artifacts/standards/fda_cybersecurity_2023.sysml +80 -0
  214. package/src/artifacts/standards/iec_60601_1.sysml +149 -0
  215. package/src/artifacts/standards/iec_60601_1_2.sysml +56 -0
  216. package/src/artifacts/standards/iec_60812.sysml +51 -0
  217. package/src/artifacts/standards/iec_62304.sysml +210 -0
  218. package/src/artifacts/standards/iec_62366_1.sysml +113 -0
  219. package/src/artifacts/standards/iec_81001_5_1.sysml +84 -0
  220. package/src/artifacts/standards/iso_13485.sysml +113 -0
  221. package/src/artifacts/standards/iso_14971.sysml +94 -0
  222. package/src/artifacts/standards/iso_iec_ieee_42010.sysml +42 -0
  223. package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml +132 -0
  224. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-input.md +1 -1
  225. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-output.md +5 -5
  226. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-review.md +1 -1
  227. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-validation.md +2 -2
  228. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-verification.md +2 -2
  229. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/dhf-index.md +2 -2
  230. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/transfer-plan.md +1 -1
  231. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/user-needs.md +1 -1
  232. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-plan.md +3 -3
  233. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-report.md +4 -4
  234. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/incident-response.md +1 -1
  235. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/postmarket-surveillance.md +3 -2
  236. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/security-arch.md +2 -2
  237. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/threat-model.md +4 -4
  238. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/vuln-assessment.md +4 -3
  239. package/src/artifacts/templates/dhf/iec-60601/hrs.md +170 -0
  240. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/detailed-design.md +1 -1
  241. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/integration-test.md +3 -3
  242. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sad.md +6 -5
  243. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sbom.md +3 -2
  244. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sdp.md +5 -4
  245. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/soup.md +4 -2
  246. package/src/artifacts/templates/dhf/iec-62304/srs.md +172 -0
  247. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sw-traceability.md +3 -3
  248. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/system-test.md +1 -1
  249. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/summative-eval.md +1 -1
  250. package/src/artifacts/templates/dhf/iec-62366/task-analysis.md +93 -0
  251. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ue-plan.md +1 -1
  252. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/urra.md +3 -3
  253. package/src/artifacts/templates/dhf/iso-14971/fmea.md +116 -0
  254. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/har.md +3 -3
  255. package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmp.md +2 -2
  256. package/src/artifacts/templates/dhf/system/sad.md +173 -0
  257. package/src/artifacts/templates/dhf/system/standards-checklist.md +87 -0
  258. package/src/artifacts/templates/dhf/system/standards-traceability.md +125 -0
  259. package/src/artifacts/templates/dhf/system/syrs.md +128 -0
  260. package/src/assurance/cybersecurity/memo_cybersecurity.sysml +39 -20
  261. package/src/assurance/human_factors/memo_human_factors.sysml +29 -22
  262. package/src/assurance/requirements/memo_requirements.sysml +5 -2
  263. package/src/assurance/requirements/needs/memo_needs.sysml +1 -1
  264. package/src/assurance/safety_risk/analysis/memo_fmea.sysml +118 -13
  265. package/src/assurance/safety_risk/memo_risk.sysml +78 -7
  266. package/src/assurance/safety_risk/postmarket_surveillance/memo_postmarket_surveillance.sysml +27 -0
  267. package/src/assurance/verification_validation/clinical_evaluation/memo_clinical_evaluation.sysml +11 -0
  268. package/src/assurance/verification_validation/memo_assurance.sysml +17 -21
  269. package/src/core/annotations/memo_annotations.sysml +96 -0
  270. package/src/core/common/memo_common.sysml +140 -18
  271. package/src/core/consistency_rules/consistency_rules.sysml +7 -0
  272. package/src/core/dimensions/dimensions.sysml +17 -1
  273. package/src/core/enumerations/memo_enumerations.sysml +101 -20
  274. package/src/core/methodology_scope/methodology_scope.sysml +7 -15
  275. package/src/core/relationships/memo_relationships.sysml +199 -194
  276. package/src/memo_namespaces.sysml +127 -67
  277. package/src/methodology/core/memo_core.sysml +69 -2
  278. package/src/methodology/profiles/memo_profiles.sysml +31 -41
  279. package/src/methodology/workflow/memo_workflow.sysml +7 -2
  280. package/src/rules/closure/closure_rules.sysml +104 -31
  281. package/src/rules/coverage/coverage_rules.sysml +4 -256
  282. package/src/rules/crosslayer/cross_layer_rules.sysml +6 -15
  283. package/src/rules/lifecycle/lifecycle_rules.sysml +4 -39
  284. package/src/rules/ontology/ontology_invariants.sysml +243 -74
  285. package/src/rules/quantitative/quantitative_rules.sysml +8 -8
  286. package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +10 -3
  287. package/src/viewpoints/clinical/clinical_viewpoint.sysml +4 -2
  288. package/src/viewpoints/clinical/{clinical_evidence_view → views/clinical_evidence_view}/clinical_evidence_view.sysml +2 -2
  289. package/src/viewpoints/context/context_viewpoint.sysml +4 -2
  290. package/src/viewpoints/context/{system_context_view → views/system_context_view}/system_context_view.sysml +2 -2
  291. package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +4 -2
  292. package/src/viewpoints/cybersecurity/{cybersecurity_assessment_view → views/cybersecurity_assessment_view}/cybersecurity_assessment_view.sysml +2 -2
  293. package/src/viewpoints/cybersecurity/{threat_model_view → views/threat_model_view}/threat_model_view.sysml +2 -2
  294. package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +5 -0
  295. package/src/viewpoints/functional/functional_viewpoint.sysml +4 -2
  296. package/src/viewpoints/functional/{function_allocation_view → views/function_allocation_view}/function_allocation_view.sysml +3 -3
  297. package/src/viewpoints/functional/{system_functional_tree_view → views/system_functional_tree_view}/system_functional_tree_view.sysml +3 -3
  298. package/src/viewpoints/logical/logical_viewpoint.sysml +3 -1
  299. package/src/viewpoints/logical/{logical_architecture_view → views/logical_architecture_view}/logical_architecture_view.sysml +2 -2
  300. package/src/viewpoints/operational/operational_viewpoint.sysml +4 -2
  301. package/src/viewpoints/operational/{use_case_view → views/use_case_view}/use_case_view.sysml +3 -3
  302. package/src/viewpoints/physical/physical_viewpoint.sysml +3 -1
  303. package/src/viewpoints/physical/{network_topology_view → views/network_topology_view}/network_topology_view.sysml +2 -2
  304. package/src/viewpoints/physical/{physical_bom_view → views/physical_bom_view}/physical_bom_view.sysml +2 -2
  305. package/src/viewpoints/rendering/memo_rendering.sysml +354 -0
  306. package/src/viewpoints/requirements/requirements_viewpoint.sysml +3 -1
  307. package/src/viewpoints/requirements/{requirements_traceability_view → views/requirements_traceability_view}/requirements_traceability_view.sysml +2 -2
  308. package/src/viewpoints/risk/risk_viewpoint.sysml +3 -1
  309. package/src/viewpoints/risk/{risk_chain_view → views/risk_chain_view}/risk_chain_view.sysml +2 -2
  310. package/src/viewpoints/software/software_viewpoint.sysml +3 -1
  311. package/src/viewpoints/software/{software_architecture_view → views/software_architecture_view}/software_architecture_view.sysml +2 -2
  312. package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +28 -0
  313. package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +23 -0
  314. package/src/viewpoints/usability/usability_viewpoint.sysml +3 -1
  315. package/src/viewpoints/usability/{usability_engineering_view → views/usability_engineering_view}/usability_engineering_view.sysml +2 -2
  316. package/src/viewpoints/verification/verification_viewpoint.sysml +4 -2
  317. package/src/viewpoints/verification/{verification_coverage_view → views/verification_coverage_view}/verification_coverage_view.sysml +3 -3
  318. package/templates/connected-device/memo.package.yaml +11 -5
  319. package/templates/connected-device/model/catalog/project.sysml +28 -0
  320. package/templates/connected-device/syside.toml +1 -1
  321. package/templates/default/memo.package.yaml +11 -5
  322. package/templates/default/model/catalog/project.sysml +28 -0
  323. package/templates/default/syside.toml +1 -1
  324. package/templates/infusion-pump/memo.package.yaml +11 -5
  325. package/templates/infusion-pump/model/catalog/project.sysml +28 -0
  326. package/templates/infusion-pump/syside.toml +1 -1
  327. package/templates/monitoring-device/memo.package.yaml +11 -5
  328. package/templates/monitoring-device/model/catalog/project.sysml +28 -0
  329. package/templates/monitoring-device/syside.toml +1 -1
  330. package/templates/samd/memo.package.yaml +11 -5
  331. package/templates/samd/model/catalog/project.sysml +28 -0
  332. package/templates/samd/syside.toml +1 -1
  333. package/examples/connected-patient-monitor/model/connected_patient_monitor.sysml +0 -3
  334. package/examples/embedded-infusion-pump/model/embedded_infusion_pump.sysml +0 -3
  335. package/examples/extensions/README.md +0 -16
  336. package/examples/extensions/clinical/memo.package.yaml +0 -9
  337. package/examples/extensions/clinical/src/methodology/clinical_methodology.sysml +0 -14
  338. package/examples/extensions/template/memo.package.yaml +0 -9
  339. package/examples/extensions/template/src/extension.sysml +0 -15
  340. package/examples/functional-logical-physical/model/functional_logical_physical.sysml +0 -3
  341. package/examples/gpca-pump/memo.config.yaml +0 -9
  342. package/examples/gpca-pump/methodology/gpca_scope.sysml +0 -25
  343. package/examples/ivd-laboratory-system/model/ivd_laboratory_system.sysml +0 -3
  344. package/examples/manual-surgical-instrument/model/manual_surgical_instrument.sysml +0 -3
  345. package/examples/multidimensional-layers/model/multidimensional_layers.sysml +0 -4
  346. package/examples/reusable-instrument/model/reusable_instrument.sysml +0 -4
  347. package/examples/software-only-medical-device/model/software_only_medical_device.sysml +0 -4
  348. package/examples/surgical-closure-workflow/model/surgical_closure_workflow.sysml +0 -4
  349. package/examples/surgical-robot/model/surgical_robot.sysml +0 -4
  350. package/examples/sysml-diagram-samples/model/samples/functional_flow_view.sysml +0 -164
  351. package/examples/sysml-diagram-samples/model/samples/interconnection_view.sysml +0 -94
  352. package/examples/sysml-diagram-samples/model/samples/operational_behaviour_view.sysml +0 -135
  353. package/examples/sysml-diagram-samples/model/samples/state_transition_view.sysml +0 -109
  354. package/examples/sysml-diagram-samples/model/samples/tree_view.sysml +0 -56
  355. package/examples/temperature-alarm/model/temperature_alarm.sysml +0 -4
  356. package/ontology/memo.rendering.yaml +0 -84
  357. package/src/compliance/artifacts/memo_artifacts.sysml +0 -12
  358. package/src/compliance/change/memo_change.sysml +0 -17
  359. package/src/compliance/dhf-templates/iec-62304/srs.md +0 -138
  360. package/src/compliance/dhf-templates/iec-62366/task-analysis.md +0 -57
  361. package/src/compliance/dhf-templates/iso-14971/fmea.md +0 -93
  362. package/src/compliance/document_views/memo_document_views.sysml +0 -7
  363. package/src/compliance/iso14971/risk_management_file.sysml +0 -16
  364. package/src/compliance/postmarket/memo_postmarket.sysml +0 -16
  365. /package/{examples/extensions → extensions}/clinical/src/clinical_extension.sysml +0 -0
  366. /package/{examples/extensions → extensions}/clinical/src/procedures/memo_clinical_procedures.sysml +0 -0
  367. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/change-record.md +0 -0
  368. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/change-control.md +0 -0
  369. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/formative-eval.md +0 -0
  370. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ui-spec.md +0 -0
  371. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/use-spec.md +0 -0
  372. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/fta.md +0 -0
  373. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-benefit.md +0 -0
  374. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-matrix.md +0 -0
  375. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmr.md +0 -0
  376. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/approval-block.md +0 -0
  377. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/document-control-header.md +0 -0
  378. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/references-section.md +0 -0
  379. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/revision-history-table.md +0 -0
  380. /package/templates/connected-device/{src → model/catalog}/architecture/system.sysml +0 -0
  381. /package/templates/connected-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  382. /package/templates/connected-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
  383. /package/templates/default/{src → model/catalog}/architecture/system.sysml +0 -0
  384. /package/templates/default/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  385. /package/templates/default/{src → model/catalog}/assurance/requirements.sysml +0 -0
  386. /package/templates/infusion-pump/{src → model/catalog}/architecture/system.sysml +0 -0
  387. /package/templates/infusion-pump/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  388. /package/templates/infusion-pump/{src → model/catalog}/assurance/requirements.sysml +0 -0
  389. /package/templates/monitoring-device/{src → model/catalog}/architecture/system.sysml +0 -0
  390. /package/templates/monitoring-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  391. /package/templates/monitoring-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
  392. /package/templates/samd/{src → model/catalog}/architecture/system.sysml +0 -0
  393. /package/templates/samd/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  394. /package/templates/samd/{src → model/catalog}/assurance/requirements.sysml +0 -0
@@ -27,14 +27,6 @@ package memo_core_enumerations {
27
27
  enum medium;
28
28
  enum low;
29
29
  }
30
- enum def RequirementStatusKind {
31
- enum draft;
32
- enum approved;
33
- enum implemented;
34
- enum verified;
35
- enum validated;
36
- enum retired;
37
- }
38
30
  enum def RequirementNotationKind {
39
31
  enum freeText;
40
32
  enum ears;
@@ -68,6 +60,31 @@ package memo_core_enumerations {
68
60
  enum mechanical;
69
61
  enum fluidic;
70
62
  }
63
+ // AADL (SAE AS5506) port category. Distinct from InterfaceKind, which says
64
+ // WHAT crosses a port; this says HOW it is delivered, and the difference is
65
+ // safety-relevant: when a deadline is missed a `data` port overwrites the
66
+ // last sample and loses it, while an `event` or `eventData` port queues,
67
+ // and a queue that outgrows its bound is a different failure with a
68
+ // different mitigation. MEMO carried the distinction on items and not on
69
+ // ports, so neither failure could be argued about at the boundary where it
70
+ // happens.
71
+ enum def PortCategoryKind {
72
+ doc /* Sampled. The reader sees the most recent value; a missed
73
+ * deadline drops a sample and never blocks. */
74
+ enum data;
75
+ doc /* Queued signal with no payload. A missed deadline grows the
76
+ * queue; overflow is the failure to bound.
77
+ *
78
+ * Quoted because `event` is reserved in SysML v2 — the same
79
+ * treatment GovernKind's `'use'` already gets. AADL's word is kept
80
+ * rather than paraphrased to `queued`: it is the term the standard
81
+ * and every AADL tool use, and a renamed one would not survive a
82
+ * round trip. */
83
+ enum 'event';
84
+ doc /* Queued signal carrying a payload — the queueing semantics of
85
+ * `event` with the value of `data`. */
86
+ enum eventData;
87
+ }
71
88
  enum def FlowKind {
72
89
  enum information;
73
90
  enum command;
@@ -79,11 +96,26 @@ package memo_core_enumerations {
79
96
  enum audit;
80
97
  enum power;
81
98
  }
99
+ // Direction of a flow across a boundary.
100
+ //
101
+ // Track A2 removed this from PORTS: a port usage says `in` / `out` /
102
+ // `inout` natively, which is the language's own spelling and the only one
103
+ // a conforming tool reads. The enum survives because four non-port
104
+ // constructs still carry a direction and none of them is a port, so none
105
+ // of them can use the keyword:
106
+ //
107
+ // Interface.direction / .directionality (interface def)
108
+ // LogicalConnector.direction (connection def)
109
+ // LogicalExchange.direction (part def)
110
+ // ComponentExchange.direction (part def)
111
+ // OperationalInteraction.direction (part def)
112
+ //
113
+ // Deleting it would have cost those five their direction; the reinvention
114
+ // was only ever the port case.
82
115
  enum def DirectionKind {
83
116
  enum input;
84
117
  enum output;
85
118
  enum inputOutput;
86
- enum bidirectional;
87
119
  }
88
120
  enum def CriticalityKind {
89
121
  enum low;
@@ -119,6 +151,25 @@ package memo_core_enumerations {
119
151
  enum formalProof;
120
152
  enum modelChecking;
121
153
  }
154
+ // The submission regime a project targets, and the regimes a standard has
155
+ // standing in. This is the axis that decides which clauses a project is
156
+ // required to claim: `required(project)` is the clauses of every standard
157
+ // whose `appliesToRegime` intersects the regimes the project's
158
+ // ProjectMethodBinding declares.
159
+ //
160
+ // The members are spelled as the regulatory designations themselves rather
161
+ // than in the lowerCamel convention the rest of this file uses. All 44 DHF
162
+ // templates already carry these exact strings in `required_for`, and any
163
+ // transformation between the enum and those arrays would be a hardcoded
164
+ // spelling map in TypeScript — the one thing the standards axis exists to
165
+ // avoid. One vocabulary, one spelling, declared here.
166
+ enum def RegulatoryRegimeKind {
167
+ enum CE;
168
+ enum MDR;
169
+ enum UKCA;
170
+ enum FDA_510k;
171
+ enum FDA_PMA;
172
+ }
122
173
  enum def ArtifactKind {
123
174
  enum plan;
124
175
  enum requirementSpecification;
@@ -192,11 +243,11 @@ package memo_core_enumerations {
192
243
  enum SDD;
193
244
  enum RMF;
194
245
  enum VV;
195
- enum ArchitectureDescription;
196
- enum CybersecurityAssessment;
197
- enum ThreatModel;
198
- enum Clinical;
199
- enum Usability;
246
+ enum architectureDescription;
247
+ enum cybersecurityAssessment;
248
+ enum threatModel;
249
+ enum clinical;
250
+ enum usability;
200
251
  }
201
252
  enum def SchedulingPolicyKind {
202
253
  enum nonRealTime;
@@ -206,12 +257,6 @@ package memo_core_enumerations {
206
257
  enum deadlineMonotonic;
207
258
  enum EDF;
208
259
  }
209
- enum def LinkStatusKind {
210
- enum planned;
211
- enum active;
212
- enum verified;
213
- enum obsolete;
214
- }
215
260
  enum def BehaviorPropertyKind {
216
261
  enum stateInvariant;
217
262
  enum transitionRule;
@@ -264,6 +309,29 @@ package memo_core_enumerations {
264
309
  enum crossLayer;
265
310
  enum quantitative;
266
311
  }
312
+ // How far a methodology may tailor a rule. `invariant` rules hold the
313
+ // ontology's own consistency and may only change in an ontology release;
314
+ // `assurance` and `methodology` rules may be disabled or replaced through
315
+ // an explicit RulePolicy carrying rationale and authority.
316
+ enum def RuleTailoringKind {
317
+ enum invariant;
318
+ enum assurance;
319
+ enum methodology;
320
+ }
321
+ enum def RuleDispositionKind {
322
+ enum enabled;
323
+ enum disabled;
324
+ enum replaced;
325
+ }
326
+ // Whether a methodology's inclusion lists are the whole selection or a
327
+ // deliberate subset. An empty list under `explicit` selects nothing; it
328
+ // never means "everything". `allAvailable` is the only way to say "all",
329
+ // and it is always deliberate. (SysML v2 reserves `all`, so the literal is
330
+ // spelled `allAvailable`.)
331
+ enum def ScopeModeKind {
332
+ enum allAvailable;
333
+ enum explicit;
334
+ }
267
335
  enum def WorkflowStageKind {
268
336
  enum context;
269
337
  enum requirements;
@@ -337,6 +405,9 @@ package memo_core_enumerations {
337
405
  enum riskTable;
338
406
  enum traceMatrix;
339
407
  enum narrativeSection;
408
+ // A captured screen with its regions drawn over it — the presentation
409
+ // of the geometry view kind.
410
+ enum screenLayout;
340
411
  enum custom;
341
412
  }
342
413
  enum def DeploymentKind {
@@ -570,4 +641,14 @@ package memo_core_enumerations {
570
641
  enum actionCategory;
571
642
  enum memoryRecall;
572
643
  }
644
+ // Lifecycle of a review remark on a model element. `rejected` is a closed
645
+ // state with a stated reason, not a deletion: a design review that
646
+ // considered a point and declined it is a record the DHF wants to keep.
647
+ enum def CommentStatusKind {
648
+ enum open;
649
+ enum acknowledged;
650
+ enum addressed;
651
+ enum resolved;
652
+ enum rejected;
653
+ }
573
654
  }
@@ -1,25 +1,17 @@
1
1
  // Methodology scope helpers.
2
- // Instances use repeated scalar attribute usages to enumerate set entries, for
3
- // example: `attribute :>> includedArchLayer = "operational";`.
2
+ //
3
+ // `MethodologyScope` and `MethodologyLayerSet` were removed when the semantic
4
+ // contract flipped. A methodology's effective selection is declared on
5
+ // `MethodologyDefinition` itself — `scopeMode` plus the `included*` lists — so
6
+ // that one element answers "what is in scope". A second scope part sitting
7
+ // beside the methodology meant two authorities for the same question, and the
8
+ // tools read the one the methodology definition did not declare.
4
9
  package memo_core_methodology_scope {
5
10
  private import ScalarValues::*;
6
11
 
7
12
  private import memo_core_common::*;
8
13
  private import memo_core_dimensions::*;
9
14
 
10
- part def MethodologyLayerSet specializes MemoPart {
11
- attribute setName : String;
12
- attribute layer : String;
13
- }
14
-
15
- part def MethodologyScope specializes MemoPart {
16
- attribute scopeName : String;
17
- attribute includedArchLayer : String[0..*];
18
- // Qualified package names may resolve to MEMO, project, supplier, or
19
- // other externally provided ontology modules.
20
- attribute includedModule : String[0..*];
21
- }
22
-
23
15
  part def ElementKindAlias specializes MemoPart {
24
16
  attribute methodTerm : String;
25
17
  attribute concreteKind : String;