@memoarchitect/ontology 0.6.5 → 0.7.0

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 (319) hide show
  1. package/README.md +1 -1
  2. package/examples/connected-patient-monitor/model/catalog/project.sysml +24 -0
  3. package/examples/connected-patient-monitor/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  4. package/examples/connected-patient-monitor/model/{viewpoints → catalog/viewpoints/unassigned/views}/connected_patient_monitor_overview.sysml +1 -1
  5. package/examples/embedded-infusion-pump/model/catalog/project.sysml +24 -0
  6. package/examples/embedded-infusion-pump/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  7. package/examples/embedded-infusion-pump/model/{viewpoints → catalog/viewpoints/unassigned/views}/embedded_infusion_pump_overview.sysml +1 -1
  8. package/examples/extensions/clinical/memo.package.yaml +18 -9
  9. package/examples/extensions/clinical/src/methodology/clinical_methodology.sysml +10 -2
  10. package/examples/extensions/template/memo.package.yaml +17 -9
  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/gpca-pump.kpar +0 -0
  15. package/examples/gpca-pump/methodology/gpca_methodology.sysml +7 -8
  16. package/examples/gpca-pump/methodology/gpca_profiles.sysml +89 -11
  17. package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +1 -1
  18. package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +1 -1
  19. package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +2 -2
  20. package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +1 -1
  21. package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +5 -5
  22. package/examples/gpca-pump/model/catalog/gpca_context.sysml +3 -8
  23. package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +6 -6
  24. package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +1 -15
  25. package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +7 -6
  26. package/examples/gpca-pump/model/catalog/gpca_operational.sysml +19 -8
  27. package/examples/gpca-pump/model/catalog/gpca_physical.sysml +2 -2
  28. package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +1 -1
  29. package/examples/gpca-pump/model/catalog/gpca_risk.sysml +1 -1
  30. package/examples/gpca-pump/model/catalog/gpca_system.sysml +34 -30
  31. package/examples/gpca-pump/model/catalog/gpca_trace.sysml +27 -23
  32. package/examples/gpca-pump/model/catalog/gpca_verification.sysml +1 -1
  33. package/examples/gpca-pump/model/catalog/project.sysml +21 -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 +3 -3
  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 +3 -3
  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 +4 -4
  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 +7 -7
  46. package/examples/gpca-pump/model/{views → catalog/viewpoints/logical/views}/logical_device_interconnect_view.sysml +3 -3
  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 +3 -3
  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 +2 -2
  52. package/examples/gpca-pump/model/{views → catalog/viewpoints/operational/views}/operational_use_case_view.sysml +3 -3
  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 +6 -6
  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 +3 -3
  60. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/document_rmf_view.sysml +3 -3
  61. package/examples/gpca-pump/model/{views → catalog/viewpoints/risk/views}/risk_fmea_view.sysml +2 -2
  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 +3 -3
  65. package/examples/gpca-pump/model/{views → catalog/viewpoints/software/views}/software_software_architecture_view.sysml +3 -3
  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 +4 -4
  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 +3 -3
  70. package/examples/gpca-pump/model/{views → catalog/viewpoints/verification/views}/verification_verification_coverage_view.sysml +2 -2
  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 +1 -0
  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/project.sysml +24 -0
  79. package/examples/multidimensional-layers/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  80. package/examples/multidimensional-layers/model/{viewpoints → catalog/viewpoints/unassigned/views}/multidimensional_layers_overview.sysml +1 -1
  81. package/examples/nested-architecture-dsm/README.md +49 -0
  82. package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +174 -0
  83. package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +183 -0
  84. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +53 -0
  85. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +89 -0
  86. package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +90 -0
  87. package/examples/nested-architecture-dsm/model/catalog/project.sysml +28 -0
  88. package/examples/nested-architecture-dsm/model/catalog/traces.sysml +49 -0
  89. package/examples/reusable-instrument/model/catalog/project.sysml +24 -0
  90. package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +7 -6
  91. package/examples/reusable-instrument/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  92. package/examples/reusable-instrument/model/{viewpoints → catalog/viewpoints/unassigned/views}/reusable_instrument_overview.sysml +1 -1
  93. package/examples/software-only-medical-device/model/catalog/project.sysml +24 -0
  94. package/examples/software-only-medical-device/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  95. package/examples/software-only-medical-device/model/{viewpoints → catalog/viewpoints/unassigned/views}/software_only_medical_device_overview.sysml +1 -1
  96. package/examples/surgical-closure-workflow/model/catalog/project.sysml +24 -0
  97. package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +23 -19
  98. package/examples/surgical-closure-workflow/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  99. package/examples/surgical-closure-workflow/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_closure_workflow_overview.sysml +1 -1
  100. package/examples/surgical-robot/model/catalog/project.sysml +24 -0
  101. package/examples/surgical-robot/model/catalog/surgical_robot.sysml +5 -3
  102. package/examples/surgical-robot/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  103. package/examples/surgical-robot/model/{viewpoints → catalog/viewpoints/unassigned/views}/surgical_robot_overview.sysml +1 -1
  104. package/examples/sysml-diagram-samples/README.md +7 -0
  105. package/examples/sysml-diagram-samples/dhf/documents/DOC-HAR-001.md +11 -0
  106. package/examples/sysml-diagram-samples/memo.package.yaml +11 -5
  107. package/examples/sysml-diagram-samples/model/catalog/project.sysml +33 -0
  108. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  109. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/action_flow_view.sysml +18 -10
  110. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/context_view.sysml +4 -2
  111. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.viewlayout +47 -0
  112. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/functional_flow_view.sysml +23 -20
  113. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/interconnection_view.sysml +17 -14
  114. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.viewlayout +94 -0
  115. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/operational_behaviour_view.sysml +23 -20
  116. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.viewlayout +13 -0
  117. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/requirements_view.sysml +3 -1
  118. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +51 -0
  119. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/state_transition_view.sysml +3 -1
  120. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/tree_view.sysml +3 -1
  121. package/examples/sysml-diagram-samples/model/{samples → catalog/viewpoints/unassigned/views}/use_case_view.sysml +3 -1
  122. package/examples/sysml-diagram-samples/model/sysml_v2_activity_example.sysml +93 -0
  123. package/examples/temperature-alarm/model/catalog/project.sysml +24 -0
  124. package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +2 -1
  125. package/examples/temperature-alarm/model/catalog/viewpoints/unassigned/viewpoint.sysml +9 -0
  126. package/examples/temperature-alarm/model/{viewpoints → catalog/viewpoints/unassigned/views}/temperature_alarm_overview.sysml +1 -1
  127. package/examples/ui-screen-regions/README.md +117 -0
  128. package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +60 -0
  129. package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +189 -0
  130. package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +61 -0
  131. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/drugSelectorRegion/drug-selector-expanded-2.4.1.png +0 -0
  132. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/mainScreenLayout/main-screen-2.4.1.png +0 -0
  133. package/examples/ui-screen-regions/model/catalog/artifacts/assets/screen-captures/settingsScreenLayout/settings-screen-2.4.1.png +0 -0
  134. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +51 -0
  135. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +27 -0
  136. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +27 -0
  137. package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +59 -0
  138. package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +25 -0
  139. package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +178 -0
  140. package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +93 -0
  141. package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +60 -0
  142. package/examples/ui-screen-regions/model/catalog/project.sysml +45 -0
  143. package/examples/ui-screen-regions/model/catalog/traces.sysml +276 -0
  144. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/viewpoint.sysml +8 -0
  145. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +62 -0
  146. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/viewpoint.sysml +8 -0
  147. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +62 -0
  148. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/viewpoint.sysml +8 -0
  149. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +62 -0
  150. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/viewpoint.sysml +8 -0
  151. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +57 -0
  152. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +52 -0
  153. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +54 -0
  154. package/memo.manifest.yaml +2 -0
  155. package/methodologies/default/memo.package.yaml +19 -9
  156. package/methodologies/gpca/memo.package.yaml +18 -9
  157. package/ontology/memo.package.yaml +23 -8
  158. package/package.json +2 -4
  159. package/profile/memo.package.yaml +18 -9
  160. package/src/architecture/decisions/memo_decisions.sysml +7 -0
  161. package/src/architecture/functional/behavior/memo_behavior.sysml +1 -1
  162. package/src/architecture/functional/functions/memo_functions.sysml +5 -12
  163. package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +1 -3
  164. package/src/architecture/implementation/software/structure/memo_software_structure.sysml +18 -5
  165. package/src/architecture/implementation/ui/memo_ui.sysml +210 -27
  166. package/src/architecture/logical/interfaces/memo_interfaces.sysml +1 -2
  167. package/src/architecture/logical/structure/memo_logical_structure.sysml +71 -15
  168. package/src/architecture/operational/activities/memo_activities.sysml +0 -1
  169. package/src/architecture/operational/scenarios/memo_scenarios.sysml +2 -2
  170. package/src/architecture/operational/workflows/memo_workflows.sysml +0 -6
  171. package/src/{compliance/change/memo_change.sysml → artifacts/configuration_management/memo_configuration_management.sysml} +5 -3
  172. package/src/artifacts/core/memo_controlled_artifacts.sysml +33 -0
  173. package/src/artifacts/documents/risk_management/memo_risk_management.sysml +12 -0
  174. package/src/assurance/cybersecurity/memo_cybersecurity.sysml +1 -1
  175. package/src/assurance/human_factors/memo_human_factors.sysml +1 -1
  176. package/src/assurance/safety_risk/postmarket_surveillance/memo_postmarket_surveillance.sysml +11 -0
  177. package/src/assurance/verification_validation/clinical_evaluation/memo_clinical_evaluation.sysml +11 -0
  178. package/src/assurance/verification_validation/memo_assurance.sysml +1 -1
  179. package/src/core/annotations/memo_annotations.sysml +77 -0
  180. package/src/core/common/memo_common.sysml +20 -3
  181. package/src/core/consistency_rules/consistency_rules.sysml +7 -0
  182. package/src/core/dimensions/dimensions.sysml +5 -1
  183. package/src/core/enumerations/memo_enumerations.sysml +41 -6
  184. package/src/core/methodology_scope/methodology_scope.sysml +7 -15
  185. package/src/core/relationships/memo_relationships.sysml +4 -2
  186. package/src/memo_namespaces.sysml +97 -67
  187. package/src/methodology/core/memo_core.sysml +45 -2
  188. package/src/methodology/profiles/memo_profiles.sysml +30 -40
  189. package/src/methodology/workflow/memo_workflow.sysml +7 -2
  190. package/src/rules/closure/closure_rules.sysml +104 -31
  191. package/src/rules/coverage/coverage_rules.sysml +4 -256
  192. package/src/rules/crosslayer/cross_layer_rules.sysml +6 -15
  193. package/src/rules/lifecycle/lifecycle_rules.sysml +4 -39
  194. package/src/rules/ontology/ontology_invariants.sysml +30 -73
  195. package/src/rules/quantitative/quantitative_rules.sysml +8 -8
  196. package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +7 -0
  197. package/src/viewpoints/clinical/clinical_viewpoint.sysml +3 -1
  198. package/src/viewpoints/clinical/{clinical_evidence_view → views/clinical_evidence_view}/clinical_evidence_view.sysml +2 -2
  199. package/src/viewpoints/context/context_viewpoint.sysml +3 -1
  200. package/src/viewpoints/context/{system_context_view → views/system_context_view}/system_context_view.sysml +2 -2
  201. package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +3 -1
  202. package/src/viewpoints/cybersecurity/{cybersecurity_assessment_view → views/cybersecurity_assessment_view}/cybersecurity_assessment_view.sysml +2 -2
  203. package/src/viewpoints/cybersecurity/{threat_model_view → views/threat_model_view}/threat_model_view.sysml +2 -2
  204. package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +4 -0
  205. package/src/viewpoints/functional/functional_viewpoint.sysml +3 -1
  206. package/src/viewpoints/functional/{function_allocation_view → views/function_allocation_view}/function_allocation_view.sysml +2 -2
  207. package/src/viewpoints/functional/{system_functional_tree_view → views/system_functional_tree_view}/system_functional_tree_view.sysml +2 -2
  208. package/src/viewpoints/logical/logical_viewpoint.sysml +3 -1
  209. package/src/viewpoints/logical/{logical_architecture_view → views/logical_architecture_view}/logical_architecture_view.sysml +2 -2
  210. package/src/viewpoints/operational/operational_viewpoint.sysml +3 -1
  211. package/src/viewpoints/operational/{use_case_view → views/use_case_view}/use_case_view.sysml +2 -2
  212. package/src/viewpoints/physical/physical_viewpoint.sysml +3 -1
  213. package/src/viewpoints/physical/{network_topology_view → views/network_topology_view}/network_topology_view.sysml +2 -2
  214. package/src/viewpoints/physical/{physical_bom_view → views/physical_bom_view}/physical_bom_view.sysml +2 -2
  215. package/src/viewpoints/rendering/memo_rendering.sysml +354 -0
  216. package/src/viewpoints/requirements/requirements_viewpoint.sysml +3 -1
  217. package/src/viewpoints/requirements/{requirements_traceability_view → views/requirements_traceability_view}/requirements_traceability_view.sysml +2 -2
  218. package/src/viewpoints/risk/risk_viewpoint.sysml +3 -1
  219. package/src/viewpoints/risk/{risk_chain_view → views/risk_chain_view}/risk_chain_view.sysml +2 -2
  220. package/src/viewpoints/software/software_viewpoint.sysml +3 -1
  221. package/src/viewpoints/software/{software_architecture_view → views/software_architecture_view}/software_architecture_view.sysml +2 -2
  222. package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +28 -0
  223. package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +23 -0
  224. package/src/viewpoints/usability/usability_viewpoint.sysml +3 -1
  225. package/src/viewpoints/usability/{usability_engineering_view → views/usability_engineering_view}/usability_engineering_view.sysml +2 -2
  226. package/src/viewpoints/verification/verification_viewpoint.sysml +3 -1
  227. package/src/viewpoints/verification/{verification_coverage_view → views/verification_coverage_view}/verification_coverage_view.sysml +2 -2
  228. package/templates/connected-device/memo.package.yaml +11 -5
  229. package/templates/connected-device/model/catalog/project.sysml +28 -0
  230. package/templates/connected-device/syside.toml +1 -1
  231. package/templates/default/memo.package.yaml +11 -5
  232. package/templates/default/model/catalog/project.sysml +28 -0
  233. package/templates/default/syside.toml +1 -1
  234. package/templates/infusion-pump/memo.package.yaml +11 -5
  235. package/templates/infusion-pump/model/catalog/project.sysml +28 -0
  236. package/templates/infusion-pump/syside.toml +1 -1
  237. package/templates/monitoring-device/memo.package.yaml +11 -5
  238. package/templates/monitoring-device/model/catalog/project.sysml +28 -0
  239. package/templates/monitoring-device/syside.toml +1 -1
  240. package/templates/samd/memo.package.yaml +11 -5
  241. package/templates/samd/model/catalog/project.sysml +28 -0
  242. package/templates/samd/syside.toml +1 -1
  243. package/examples/connected-patient-monitor/model/connected_patient_monitor.sysml +0 -3
  244. package/examples/embedded-infusion-pump/model/embedded_infusion_pump.sysml +0 -3
  245. package/examples/functional-logical-physical/model/functional_logical_physical.sysml +0 -3
  246. package/examples/gpca-pump/memo.config.yaml +0 -9
  247. package/examples/gpca-pump/methodology/gpca_scope.sysml +0 -25
  248. package/examples/ivd-laboratory-system/model/ivd_laboratory_system.sysml +0 -3
  249. package/examples/manual-surgical-instrument/model/manual_surgical_instrument.sysml +0 -3
  250. package/examples/multidimensional-layers/model/multidimensional_layers.sysml +0 -4
  251. package/examples/reusable-instrument/model/reusable_instrument.sysml +0 -4
  252. package/examples/software-only-medical-device/model/software_only_medical_device.sysml +0 -4
  253. package/examples/surgical-closure-workflow/model/surgical_closure_workflow.sysml +0 -4
  254. package/examples/surgical-robot/model/surgical_robot.sysml +0 -4
  255. package/examples/temperature-alarm/model/temperature_alarm.sysml +0 -4
  256. package/ontology/memo.rendering.yaml +0 -84
  257. package/src/compliance/artifacts/memo_artifacts.sysml +0 -12
  258. package/src/compliance/document_views/memo_document_views.sysml +0 -7
  259. package/src/compliance/iso14971/risk_management_file.sysml +0 -16
  260. package/src/compliance/postmarket/memo_postmarket.sysml +0 -16
  261. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/change-record.md +0 -0
  262. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-input.md +0 -0
  263. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-output.md +0 -0
  264. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-review.md +0 -0
  265. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-validation.md +0 -0
  266. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/design-verification.md +0 -0
  267. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/dhf-index.md +0 -0
  268. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/transfer-plan.md +0 -0
  269. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/user-needs.md +0 -0
  270. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-plan.md +0 -0
  271. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/21cfr820/vv-report.md +0 -0
  272. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/incident-response.md +0 -0
  273. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/postmarket-surveillance.md +0 -0
  274. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/security-arch.md +0 -0
  275. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/threat-model.md +0 -0
  276. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/vuln-assessment.md +0 -0
  277. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/change-control.md +0 -0
  278. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/detailed-design.md +0 -0
  279. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/integration-test.md +0 -0
  280. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sad.md +0 -0
  281. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sbom.md +0 -0
  282. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sdp.md +0 -0
  283. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/soup.md +0 -0
  284. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/srs.md +0 -0
  285. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sw-traceability.md +0 -0
  286. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/system-test.md +0 -0
  287. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/formative-eval.md +0 -0
  288. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/summative-eval.md +0 -0
  289. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/task-analysis.md +0 -0
  290. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ue-plan.md +0 -0
  291. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/ui-spec.md +0 -0
  292. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/urra.md +0 -0
  293. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/use-spec.md +0 -0
  294. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/fmea.md +0 -0
  295. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/fta.md +0 -0
  296. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/har.md +0 -0
  297. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-benefit.md +0 -0
  298. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/risk-matrix.md +0 -0
  299. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmp.md +0 -0
  300. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iso-14971/rmr.md +0 -0
  301. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/approval-block.md +0 -0
  302. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/document-control-header.md +0 -0
  303. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/references-section.md +0 -0
  304. /package/src/{compliance/dhf-templates → artifacts/templates/dhf}/shared/snippets/revision-history-table.md +0 -0
  305. /package/templates/connected-device/{src → model/catalog}/architecture/system.sysml +0 -0
  306. /package/templates/connected-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  307. /package/templates/connected-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
  308. /package/templates/default/{src → model/catalog}/architecture/system.sysml +0 -0
  309. /package/templates/default/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  310. /package/templates/default/{src → model/catalog}/assurance/requirements.sysml +0 -0
  311. /package/templates/infusion-pump/{src → model/catalog}/architecture/system.sysml +0 -0
  312. /package/templates/infusion-pump/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  313. /package/templates/infusion-pump/{src → model/catalog}/assurance/requirements.sysml +0 -0
  314. /package/templates/monitoring-device/{src → model/catalog}/architecture/system.sysml +0 -0
  315. /package/templates/monitoring-device/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  316. /package/templates/monitoring-device/{src → model/catalog}/assurance/requirements.sysml +0 -0
  317. /package/templates/samd/{src → model/catalog}/architecture/system.sysml +0 -0
  318. /package/templates/samd/{src/artifacts/artifacts.sysml → model/catalog/artifacts/catalog.sysml} +0 -0
  319. /package/templates/samd/{src → model/catalog}/assurance/requirements.sysml +0 -0
package/README.md CHANGED
@@ -23,7 +23,7 @@ pin an exact release; the package has no repository or runtime dependency on Mem
23
23
  Tools or Memo Architect.
24
24
 
25
25
  ```bash
26
- pnpm add @memoarchitect/ontology@0.6.4
26
+ pnpm add @memoarchitect/ontology@0.7.0
27
27
  ```
28
28
 
29
29
  > **Pre-1.0 notice:** ontology names, relationships, and package layout may
@@ -0,0 +1,24 @@
1
+ // Connected Patient Monitor — project identity and method binding.
2
+ //
3
+ // The native entrypoint. The imports name what this project contains and the
4
+ // binding names the methodology it is governed by. No YAML file participates.
5
+ package memo_examples_connected_patient_monitor_project {
6
+ private import ScalarValues::*;
7
+
8
+ private import memo_core_enumerations::*;
9
+ private import memo_methodology_core::*;
10
+ private import memo_methodology_profiles::*;
11
+
12
+ // The project's own content, imported so the catalog is one reachable
13
+ // closure from a single entrypoint.
14
+ private import memo_examples_connected_patient_monitor_viewpoints_unassigned::*;
15
+ private import memo_examples_connected_patient_monitor_viewpoints_unassigned_views_connected_patient_monitor_overview::*;
16
+
17
+ part projectBinding : ProjectMethodBinding {
18
+ attribute :>> id = "PMB-PATIENT-MONITOR-001";
19
+ attribute :>> name = "ConnectedPatientMonitorProjectMethodBinding";
20
+ attribute :>> projectName = "Connected Patient Monitor";
21
+ ref :>> selectedMethodology = mdDefaultDefinition;
22
+ attribute :>> scopeMode = ScopeModeKind::explicit;
23
+ }
24
+ }
@@ -0,0 +1,9 @@
1
+ // unassigned viewpoint.
2
+ //
3
+ // This project does not define its own viewpoint here; it binds the reusable
4
+ // MEMO viewpoint that frames these concerns. The views it governs sit beneath
5
+ // `views/`.
6
+ package memo_examples_connected_patient_monitor_viewpoints_unassigned {
7
+ // The reusable package declaring unassigned could not be resolved during
8
+ // conversion. Import it here so the views beneath this viewpoint resolve.
9
+ }
@@ -1,4 +1,4 @@
1
- package memo_examples_connected_patient_monitor_viewpoints {
1
+ package memo_examples_connected_patient_monitor_viewpoints_unassigned_views_connected_patient_monitor_overview {
2
2
  private import memo_examples_connected_patient_monitor::*;
3
3
  private import memo_viewpoints_definitions::*;
4
4
  private import memo_core_enumerations::*;
@@ -0,0 +1,24 @@
1
+ // Embedded Infusion Pump — project identity and method binding.
2
+ //
3
+ // The native entrypoint. The imports name what this project contains and the
4
+ // binding names the methodology it is governed by. No YAML file participates.
5
+ package memo_examples_embedded_infusion_pump_project {
6
+ private import ScalarValues::*;
7
+
8
+ private import memo_core_enumerations::*;
9
+ private import memo_methodology_core::*;
10
+ private import memo_methodology_profiles::*;
11
+
12
+ // The project's own content, imported so the catalog is one reachable
13
+ // closure from a single entrypoint.
14
+ private import memo_examples_embedded_infusion_pump_viewpoints_unassigned::*;
15
+ private import memo_examples_embedded_infusion_pump_viewpoints_unassigned_views_embedded_infusion_pump_overview::*;
16
+
17
+ part projectBinding : ProjectMethodBinding {
18
+ attribute :>> id = "PMB-INFUSION-PUMP-001";
19
+ attribute :>> name = "EmbeddedInfusionPumpProjectMethodBinding";
20
+ attribute :>> projectName = "Embedded Infusion Pump";
21
+ ref :>> selectedMethodology = mdDefaultDefinition;
22
+ attribute :>> scopeMode = ScopeModeKind::explicit;
23
+ }
24
+ }
@@ -0,0 +1,9 @@
1
+ // unassigned viewpoint.
2
+ //
3
+ // This project does not define its own viewpoint here; it binds the reusable
4
+ // MEMO viewpoint that frames these concerns. The views it governs sit beneath
5
+ // `views/`.
6
+ package memo_examples_embedded_infusion_pump_viewpoints_unassigned {
7
+ // The reusable package declaring unassigned could not be resolved during
8
+ // conversion. Import it here so the views beneath this viewpoint resolve.
9
+ }
@@ -1,4 +1,4 @@
1
- package memo_examples_embedded_infusion_pump_viewpoints {
1
+ package memo_examples_embedded_infusion_pump_viewpoints_unassigned_views_embedded_infusion_pump_overview {
2
2
  private import memo_examples_embedded_infusion_pump::*;
3
3
  private import memo_viewpoints_definitions::*;
4
4
  private import memo_core_enumerations::*;
@@ -1,9 +1,18 @@
1
- name: "@memoarchitect/example-extension-clinical"
2
- version: "0.6.1"
3
- type: methodology
4
- extends: "@memoarchitect/methodology-default"
5
- sysmlDir: "./src"
6
- description: "Example methodology extension for clinical-procedure vocabulary"
7
- license: "MIT"
8
- tags: ["memo", "methodology", "extension", "clinical"]
9
- usage: ["extension", "clinical-procedures"]
1
+ # Application/distribution descriptor for this MEMO package.
2
+ #
3
+ # Identity and location only. It records what this package is called, what
4
+ # version it is, and where its SysML source sits so a resolver can find it.
5
+ # It does not select model content: the project's native SysML imports and its
6
+ # ProjectMethodBinding decide what is in the model. Semantic fields
7
+ # (`type`, `extends`, `usage`, `ontologies`, `methodology`, `modules`) were
8
+ # removed at the native semantic flip and are now rejected if present.
9
+ name: '@memoarchitect/example-extension-clinical'
10
+ version: 0.6.1
11
+ description: Example methodology extension for clinical-procedure vocabulary
12
+ license: MIT
13
+ tags:
14
+ - memo
15
+ - methodology
16
+ - extension
17
+ - clinical
18
+ sysmlDir: ./src
@@ -1,14 +1,22 @@
1
1
  package memo_extension_clinical_methodology {
2
2
  private import ScalarValues::*;
3
3
  private import memo_methodology_core::*;
4
+ private import memo_methodology_profiles::*;
5
+ private import memo_core_enumerations::*;
4
6
 
5
7
  part clinicalExtensionMethod : MethodologyDefinition {
6
8
  attribute :>> id = "EXT-CLINICAL-001";
7
9
  attribute :>> name = "ClinicalProcedureExtension";
8
- attribute :>> version = "0.6.1";
10
+ attribute :>> version = "0.6.5";
9
11
  attribute :>> domain = "clinical procedures";
10
12
  attribute :>> description = "Adds optional clinical-procedure vocabulary to a MEMO project.";
11
- attribute :>> baseMethodName = "MedicalDeviceLightDefault";
13
+ // The base is a typed SysML reference, not a name to keep in sync with
14
+ // another file. `baseMethodName` was the pre-flip spelling and no
15
+ // longer resolves.
16
+ ref :>> baseMethodology = mdDefaultDefinition;
17
+ // An extension adds its own module to whatever its base selected;
18
+ // saying so explicitly is required now that an empty list means empty.
19
+ attribute :>> scopeMode = ScopeModeKind::explicit;
12
20
  attribute :>> includedModule = "memo_extension_clinical";
13
21
  }
14
22
  }
@@ -1,9 +1,17 @@
1
- name: "{{name}}"
2
- version: "0.1.0"
3
- type: methodology
4
- extends: "@memoarchitect/methodology-default"
5
- sysmlDir: "./src"
6
- description: "MEMO methodology extension"
7
- license: "MIT"
8
- tags: ["memo", "methodology", "extension"]
9
- usage: ["extension"]
1
+ # Application/distribution descriptor for this MEMO package.
2
+ #
3
+ # Identity and location only. It records what this package is called, what
4
+ # version it is, and where its SysML source sits so a resolver can find it.
5
+ # It does not select model content: the project's native SysML imports and its
6
+ # ProjectMethodBinding decide what is in the model. Semantic fields
7
+ # (`type`, `extends`, `usage`, `ontologies`, `methodology`, `modules`) were
8
+ # removed at the native semantic flip and are now rejected if present.
9
+ name: '{{name}}'
10
+ version: 0.1.0
11
+ description: MEMO methodology extension
12
+ license: MIT
13
+ tags:
14
+ - memo
15
+ - methodology
16
+ - extension
17
+ sysmlDir: ./src
@@ -0,0 +1,24 @@
1
+ // Functional Logical Physical — project identity and method binding.
2
+ //
3
+ // The native entrypoint. The imports name what this project contains and the
4
+ // binding names the methodology it is governed by. No YAML file participates.
5
+ package memo_examples_functional_logical_physical_project {
6
+ private import ScalarValues::*;
7
+
8
+ private import memo_core_enumerations::*;
9
+ private import memo_methodology_core::*;
10
+ private import memo_methodology_profiles::*;
11
+
12
+ // The project's own content, imported so the catalog is one reachable
13
+ // closure from a single entrypoint.
14
+ private import memo_examples_functional_logical_physical_viewpoints_unassigned::*;
15
+ private import memo_examples_functional_logical_physical_viewpoints_unassigned_views_functional_logical_physical_overview::*;
16
+
17
+ part projectBinding : ProjectMethodBinding {
18
+ attribute :>> id = "PMB-LOGICAL-PHYSICAL-001";
19
+ attribute :>> name = "FunctionalLogicalPhysicalProjectMethodBinding";
20
+ attribute :>> projectName = "Functional Logical Physical";
21
+ ref :>> selectedMethodology = mdDefaultDefinition;
22
+ attribute :>> scopeMode = ScopeModeKind::explicit;
23
+ }
24
+ }
@@ -0,0 +1,9 @@
1
+ // unassigned viewpoint.
2
+ //
3
+ // This project does not define its own viewpoint here; it binds the reusable
4
+ // MEMO viewpoint that frames these concerns. The views it governs sit beneath
5
+ // `views/`.
6
+ package memo_examples_functional_logical_physical_viewpoints_unassigned {
7
+ // The reusable package declaring unassigned could not be resolved during
8
+ // conversion. Import it here so the views beneath this viewpoint resolve.
9
+ }
@@ -1,4 +1,4 @@
1
- package memo_examples_functional_logical_physical_viewpoints {
1
+ package memo_examples_functional_logical_physical_viewpoints_unassigned_views_functional_logical_physical_overview {
2
2
  private import memo_examples_functional_logical_physical::*;
3
3
  private import memo_viewpoints_definitions::*;
4
4
  private import memo_core_enumerations::*;
@@ -1,11 +1,10 @@
1
+ // The GPCA methodology package.
2
+ //
3
+ // The `ResolvesToMethodology` connection that used to live here bound a model
4
+ // element to an authored `ResolvedMethodology` instance. A resolved methodology
5
+ // is derived from the project binding and the methodology chain, so there is
6
+ // nothing here to connect to: see `model/catalog/gpca_project.sysml` for the
7
+ // binding, and `gpca_profiles.sysml` for the methodology it selects.
1
8
  package memo_examples_gpca_pump_methodology_gpca_methodology {
2
- private import ScalarValues::*;
3
-
4
- private import memo_methodology_profiles::*;
5
9
  private import memo_examples_gpca_pump_methodology_gpca_profiles::*;
6
- private import memo_core_relationships::*;
7
- private import memo_examples_gpca_pump_model_catalog_gpca_requirements::*;
8
- private import memo_examples_gpca_pump_model_catalog_gpca_architecture::*;
9
-
10
- connection : ResolvesToMethodology connect boundModelElement ::> tlm to resolvedMethodology ::> gpcaMethodResolved;
11
10
  }
@@ -1,25 +1,103 @@
1
+ // GPCA prototype methodology.
2
+ //
3
+ // Converted from subtraction to explicit selection at the native semantic flip.
4
+ // Before, this methodology said "the default, minus cybersecurity and SOUP" by
5
+ // listing `excludedKind` entries on a separate `MethodologyScope` part. ADR-1-15
6
+ // requires a methodology to declare its own final effective lists, so the
7
+ // selection is now stated positively here and the scope part is gone.
8
+ //
9
+ // Two differences from the pre-flip behaviour are deliberate and recorded:
10
+ //
11
+ // 1. Cybersecurity is excluded by *not* selecting `memo_assurance_cybersecurity`
12
+ // and by two explicit RulePolicy entries disabling the cybersecurity closure
13
+ // rules. Before, `excludedKind` named eleven cybersecurity kinds; naming the
14
+ // discipline once is the same selection stated at the level the methodology
15
+ // metamodel supports.
16
+ // 2. `SoftwareModule[moduleKind=soup]` cannot be expressed as an inclusion.
17
+ // Explicit selection works over kinds, not over instance attribute values,
18
+ // so a per-instance filter has no positive form. The GPCA model declares no
19
+ // SOUP module, so the effective element set is unchanged; the intent is
20
+ // recorded in this methodology's description and belongs to a project rule
21
+ // if it ever needs enforcing.
22
+ //
23
+ // The authored `gpcaMethodResolved : ResolvedMethodology` is gone. A resolved
24
+ // methodology is derived from the binding and the methodology chain; authoring
25
+ // one by hand created a second answer that no resolver produced.
1
26
  package memo_examples_gpca_pump_methodology_gpca_profiles {
2
27
  private import ScalarValues::*;
3
28
 
4
29
  private import memo_methodology_core::*;
5
30
  private import memo_methodology_profiles::*;
6
31
  private import memo_core_enumerations::*;
32
+ private import memo_rules_closure::*;
7
33
 
8
34
  part gpcaMethodDefinition : MethodologyDefinition {
9
35
  attribute :>> id = "METH-GPCA-001";
10
36
  attribute :>> name = "GPCAPrototypeMethodology";
11
- attribute :>> version = "1.0";
37
+ attribute :>> version = "0.6.5";
12
38
  attribute :>> domain = "medical device modeling";
13
- attribute :>> description = "GPCA infusion pump methodology — subtraction-based tailoring for non-networked prototype. Excludes cybersecurity layer and SOUP modules.";
14
- attribute :>> baseMethodName = "MedicalDeviceLightDefault";
15
- }
39
+ attribute :>> description = "GPCA infusion pump methodology for the non-networked prototype variant. Explicitly selects the five architecture layers and four of the five assurance disciplines; cybersecurity is out of scope because the prototype has no network interface. The prototype uses no SOUP.";
40
+ ref :>> baseMethodology = mdDefaultDefinition;
41
+ attribute :>> scopeMode = ScopeModeKind::explicit;
42
+
43
+ attribute :>> includedLayer = (
44
+ "memo_architecture_operational",
45
+ "memo_architecture_functional",
46
+ "memo_architecture_logical",
47
+ "memo_architecture_implementation",
48
+ "memo_architecture_realization"
49
+ );
50
+
51
+ // Explicit means explicit. A methodology that names its assurance
52
+ // disciplines and stops there selects no rules at all, because rules
53
+ // live in their own packages. Before the flip an empty list read as
54
+ // "everything", which hid exactly this: the selection said nothing and
55
+ // the tools behaved as though it said everything.
56
+ attribute :>> includedModule = (
57
+ "memo_core_common",
58
+ "memo_core_enumerations",
59
+ "memo_core_relationships",
60
+ "memo_core_annotations",
61
+ "memo_core_consistency_rules",
62
+ "memo_assurance_requirements",
63
+ "memo_assurance_requirements_needs",
64
+ "memo_assurance_safety_risk",
65
+ "memo_assurance_human_factors",
66
+ "memo_assurance_verification_validation",
67
+ "memo_rules_closure",
68
+ "memo_rules_crosslayer",
69
+ "memo_rules_quantitative",
70
+ "memo_rules_ontology"
71
+ );
72
+
73
+ attribute :>> includedStandard = (
74
+ "ISO 14971",
75
+ "IEC 62304",
76
+ "21 CFR 820",
77
+ "ISO 13485",
78
+ "ISO 14155",
79
+ "IEC 62366",
80
+ "IEC 60601-1"
81
+ );
82
+
83
+ attribute :>> includedArtifactKind = ("RiskManagementPlan");
84
+
85
+ attribute :>> includedViewpoint = ("VP-CTX", "VP-LOG", "VP-RISK");
86
+
87
+ part disableThreatMitigation : RulePolicy :> rulePolicy {
88
+ ref :>> targetRule : ThreatMitigationRule;
89
+ attribute :>> disposition = RuleDispositionKind::disabled;
90
+ attribute :>> rationaleText = "CR-MED-040 requires every threat to carry a mitigation. The prototype has no network or removable-media interface, so no threat is in scope and the rule can only report on elements this variant does not model.";
91
+ attribute :>> authority = "GPCA Systems Engineering Lead";
92
+ attribute :>> approvalReference = "GPCA-DHF-CR-0007";
93
+ }
16
94
 
17
- part gpcaMethodResolved : ResolvedMethodology {
18
- attribute :>> id = "RMETH-GPCA-001";
19
- attribute :>> name = "GPCAPrototypeResolved";
20
- attribute :>> version = "1.0";
21
- attribute :>> safetyClassification = SafetyClassKind::C;
22
- attribute :>> lifecycleStage = LifecycleStateKind::development;
23
- attribute :>> resolutionSummary = "GPCA infusion pump — IEC 62304 Class C at development stage. Default scope minus cybersecurity and SOUP, as the prototype is non-networked.";
95
+ part disableAssetThreatLink : RulePolicy :> rulePolicy {
96
+ ref :>> targetRule : AssetThreatLinkRule;
97
+ attribute :>> disposition = RuleDispositionKind::disabled;
98
+ attribute :>> rationaleText = "CR-MED-041 requires every cybersecurity asset to trace to a threat. Cybersecurity is not a selected discipline for this variant, so the rule has no subjects and its absence is recorded here rather than left implicit.";
99
+ attribute :>> authority = "GPCA Systems Engineering Lead";
100
+ attribute :>> approvalReference = "GPCA-DHF-CR-0007";
101
+ }
24
102
  }
25
103
  }
@@ -1,4 +1,4 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_analysis {
1
+ package memo_examples_gpca_pump_gpca_analysis {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_assurance_safety_risk_analysis::*;
@@ -1,4 +1,4 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_architecture {
1
+ package memo_examples_gpca_pump_gpca_architecture {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_architecture_implementation_hardware_structure::*;
@@ -1,6 +1,6 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_behavior_actions {
1
+ package memo_examples_gpca_pump_gpca_behavior_actions {
2
2
  private import ScalarValues::*;
3
- private import memo_examples_gpca_pump_model_catalog_gpca_architecture::*;
3
+ private import memo_examples_gpca_pump_gpca_architecture::*;
4
4
 
5
5
  private import memo_architecture_functional_behavior::*;
6
6
  private import memo_architecture_logical_interfaces::*;
@@ -1,4 +1,4 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_behavior_modes {
1
+ package memo_examples_gpca_pump_gpca_behavior_modes {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_architecture_functional_behavior::*;
@@ -1,8 +1,12 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_behavior_subsystems {
1
+ package memo_examples_gpca_pump_gpca_behavior_subsystems {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_architecture_functional_functions::*;
5
5
  private import memo_core_enumerations::*;
6
+ private import memo_architecture_logical_interfaces::*;
7
+ private import memo_architecture_operational_use_cases::*;
8
+ private import memo_assurance_requirements::*;
9
+ private import memo_core_common::*;
6
10
 
7
11
  // ── Logical functions ───────────────────────────────────────
8
12
  part fnAcquireSensors : SystemFunction {
@@ -110,7 +114,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_behavior_subsystems {
110
114
  attribute :>> id = "LF-001";
111
115
  attribute :>> name = "SensorAcquisitionFlow";
112
116
  attribute :>> flowKind = FlowKind::measurement;
113
- attribute :>> direction = DirectionKind::input;
114
117
  attribute :>> latencyBudgetMs = 20.0;
115
118
  attribute :>> staleAfterMs = 40.0;
116
119
  attribute :>> integrityLevel = "class C data path";
@@ -121,7 +124,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_behavior_subsystems {
121
124
  attribute :>> id = "LF-002";
122
125
  attribute :>> name = "FlowCommandFlow";
123
126
  attribute :>> flowKind = FlowKind::command;
124
- attribute :>> direction = DirectionKind::output;
125
127
  attribute :>> latencyBudgetMs = 20.0;
126
128
  attribute :>> staleAfterMs = 20.0;
127
129
  attribute :>> integrityLevel = "class C command path";
@@ -132,7 +134,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_behavior_subsystems {
132
134
  attribute :>> id = "LF-003";
133
135
  attribute :>> name = "AlarmSignalFlow";
134
136
  attribute :>> flowKind = FlowKind::alarm;
135
- attribute :>> direction = DirectionKind::output;
136
137
  attribute :>> latencyBudgetMs = 20.0;
137
138
  attribute :>> staleAfterMs = 20.0;
138
139
  attribute :>> integrityLevel = "class C alarm path; same-step delivery to infusion manager";
@@ -143,7 +144,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_behavior_subsystems {
143
144
  attribute :>> id = "LF-004";
144
145
  attribute :>> name = "PrescriptionEntryFlow";
145
146
  attribute :>> flowKind = FlowKind::configuration;
146
- attribute :>> direction = DirectionKind::input;
147
147
  attribute :>> latencyBudgetMs = 500.0;
148
148
  attribute :>> staleAfterMs = 0.0;
149
149
  attribute :>> integrityLevel = "confirmed double-entry path";
@@ -1,4 +1,4 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_context {
1
+ package memo_examples_gpca_pump_gpca_context {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_architecture_operational_context_actors::*;
@@ -13,7 +13,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
13
13
  attribute :>> name = "GPCA_IntendedUse";
14
14
  attribute :>> title = "GPCA Pump Intended Use";
15
15
  attribute :>> shortDescription = "Patient-controlled analgesia infusion of prescribed opioid analgesics.";
16
- attribute :>> longDescription = "The GPCA pump delivers a prescribed analgesic drug intravenously at a programmed basal rate, supplemented by square boluses delivered automatically at programmed intervals and by patient-requested bolus doses, subject to lockout intervals and maximum-dose limits.";
16
+ attribute :>> description = "The GPCA pump delivers a prescribed analgesic drug intravenously at a programmed basal rate, supplemented by square boluses delivered automatically at programmed intervals and by patient-requested bolus doses, subject to lockout intervals and maximum-dose limits.";
17
17
  attribute :>> indication = "Management of acute post-operative or chronic pain requiring titrated intravenous opioid analgesia.";
18
18
  attribute :>> contraindication = "Patients unable to comprehend or operate the bolus request mechanism; drugs without safe-value records in the hospital pharmacy database.";
19
19
  attribute :>> patientPopulation = "Adult in-patients under clinical supervision.";
@@ -26,7 +26,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
26
26
  attribute :>> name = "BolusRequestBySomeoneOtherThanPatient";
27
27
  attribute :>> title = "Bolus by proxy";
28
28
  attribute :>> shortDescription = "A caregiver or visitor presses the patient bolus control.";
29
- attribute :>> longDescription = "A person other than the patient activates the bolus request control, bypassing the intended patient self-limiting behavior.";
29
+ attribute :>> description = "A person other than the patient activates the bolus request control, bypassing the intended patient self-limiting behavior.";
30
30
  attribute :>> misuseContext = "Patient-controlled analgesia in a supervised hospital setting.";
31
31
  attribute :>> foreseeableBasis = "Known PCA use pattern represented in the GPCA hazard analysis.";
32
32
  attribute :>> affectedUseContext = "UC-001";
@@ -51,7 +51,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
51
51
  attribute :>> actorKind = ActorKind::patient;
52
52
  attribute :>> id = "ACT-001";
53
53
  attribute :>> name = "Patient";
54
- attribute :>> actorKind = ActorKind::patient;
55
54
  attribute :>> trainingLevel = "instructed by clinician on bolus request button only";
56
55
  attribute :>> description = "Receives the infusion and requests bolus doses via the patient pendant.";
57
56
  }
@@ -59,7 +58,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
59
58
  attribute :>> actorKind = ActorKind::clinician;
60
59
  attribute :>> id = "ACT-002";
61
60
  attribute :>> name = "ClinicianNurse";
62
- attribute :>> actorKind = ActorKind::clinician;
63
61
  attribute :>> trainingLevel = "trained clinical user; programs prescriptions and responds to alarms";
64
62
  attribute :>> description = "Loads the drug reservoir, programs and confirms the prescription, starts/stops therapy, and responds to alarms.";
65
63
  }
@@ -67,7 +65,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
67
65
  attribute :>> actorKind = ActorKind::clinician;
68
66
  attribute :>> id = "ACT-003";
69
67
  attribute :>> name = "PrescribingPhysician";
70
- attribute :>> actorKind = ActorKind::clinician;
71
68
  attribute :>> trainingLevel = "licensed prescriber";
72
69
  attribute :>> description = "Prescribes drug, concentration, basal rate, bolus volume, lockout interval, and maximum dose limits.";
73
70
  }
@@ -75,7 +72,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
75
72
  attribute :>> actorKind = ActorKind::clinician;
76
73
  attribute :>> id = "ACT-004";
77
74
  attribute :>> name = "Pharmacist";
78
- attribute :>> actorKind = ActorKind::clinician;
79
75
  attribute :>> trainingLevel = "licensed pharmacist";
80
76
  attribute :>> description = "Prepares the drug reservoir and verifies drug and concentration against the prescription.";
81
77
  }
@@ -83,7 +79,6 @@ package memo_examples_gpca_pump_model_catalog_gpca_context {
83
79
  attribute :>> actorKind = ActorKind::technician;
84
80
  attribute :>> id = "ACT-005";
85
81
  attribute :>> name = "BiomedicalTechnician";
86
- attribute :>> actorKind = ActorKind::technician;
87
82
  attribute :>> trainingLevel = "service-trained; authenticated service access";
88
83
  attribute :>> description = "Performs maintenance, battery replacement, and calibration through the service interface.";
89
84
  }
@@ -1,4 +1,4 @@
1
- package memo_examples_gpca_pump_model_catalog_gpca_cybersecurity {
1
+ package memo_examples_gpca_pump_gpca_cybersecurity {
2
2
  private import ScalarValues::*;
3
3
 
4
4
  private import memo_assurance_cybersecurity::*;
@@ -7,10 +7,10 @@ package memo_examples_gpca_pump_model_catalog_gpca_cybersecurity {
7
7
  private import memo_assurance_verification_validation::*;
8
8
  private import memo_core_enumerations::*;
9
9
  private import memo_core_relationships::*;
10
- private import memo_examples_gpca_pump_model_catalog_gpca_architecture::*;
11
- private import memo_examples_gpca_pump_model_catalog_gpca_risk::*;
12
- private import memo_examples_gpca_pump_model_catalog_gpca_requirements::*;
13
- private import memo_examples_gpca_pump_model_catalog_gpca_verification::*;
10
+ private import memo_examples_gpca_pump_gpca_architecture::*;
11
+ private import memo_examples_gpca_pump_gpca_risk::*;
12
+ private import memo_examples_gpca_pump_gpca_requirements::*;
13
+ private import memo_examples_gpca_pump_gpca_verification::*;
14
14
 
15
15
  part therapyConfigurationAsset : CybersecurityAsset {
16
16
  attribute :>> id = "AST-CYB-001";
@@ -78,7 +78,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_cybersecurity {
78
78
  attribute :>> cweReference = "CWE-798";
79
79
  }
80
80
 
81
- part tamperedConfigurationScenario : ThreatScenario {
81
+ action tamperedConfigurationScenario : ThreatScenario {
82
82
  attribute :>> id = "SCN-001";
83
83
  attribute :>> name = "TamperedTherapyConfigurationScenario";
84
84
  attribute :>> description = "An attacker with local access to the maintenance port alters lockout or dose parameters, aiming to bypass safety limits; may enable unsafe therapy delivery or bypass safeguards.";