@memoarchitect/ontology 0.8.24 → 0.11.0

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Files changed (203) hide show
  1. package/README.md +1 -1
  2. package/examples/connected-patient-monitor/model/catalog/connected_patient_monitor.sysml +9 -7
  3. package/examples/connected-patient-monitor/model/catalog/project.sysml +3 -1
  4. package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +9 -7
  5. package/examples/embedded-infusion-pump/model/catalog/project.sysml +3 -1
  6. package/examples/functional-logical-physical/model/catalog/functional_logical_physical.sysml +8 -6
  7. package/examples/functional-logical-physical/model/catalog/project.sysml +3 -1
  8. package/examples/gpca-pump/memo.identity.yaml +2185 -0
  9. package/examples/gpca-pump/methodology/gpca_profiles.sysml +3 -1
  10. package/examples/gpca-pump/model/catalog/gpca_analysis.sysml +29 -27
  11. package/examples/gpca-pump/model/catalog/gpca_architecture.sysml +115 -114
  12. package/examples/gpca-pump/model/catalog/gpca_behavior_modes.sysml +42 -41
  13. package/examples/gpca-pump/model/catalog/gpca_behavior_subsystems.sysml +26 -25
  14. package/examples/gpca-pump/model/catalog/gpca_context.sysml +29 -24
  15. package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +14 -13
  16. package/examples/gpca-pump/model/catalog/gpca_formal_behavior.sysml +42 -40
  17. package/examples/gpca-pump/model/catalog/gpca_interfaces.sysml +198 -197
  18. package/examples/gpca-pump/model/catalog/gpca_operational.sysml +121 -125
  19. package/examples/gpca-pump/model/catalog/gpca_physical.sysml +8 -6
  20. package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +390 -388
  21. package/examples/gpca-pump/model/catalog/gpca_risk.sysml +164 -163
  22. package/examples/gpca-pump/model/catalog/gpca_standards.sysml +44 -43
  23. package/examples/gpca-pump/model/catalog/gpca_system.sysml +15 -14
  24. package/examples/gpca-pump/model/catalog/gpca_trace.sysml +10 -8
  25. package/examples/gpca-pump/model/catalog/gpca_verification.sysml +62 -61
  26. package/examples/gpca-pump/model/catalog/project.sysml +3 -1
  27. package/examples/gpca-pump/model/catalog/viewpoints/context/views/context_system_context_view.sysml +6 -4
  28. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/cybersecurity_cybersecurity_view.sysml +5 -3
  29. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_cyber_assessment_view.sysml +5 -3
  30. package/examples/gpca-pump/model/catalog/viewpoints/cybersecurity/views/document_threat_model_view.sysml +5 -3
  31. package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_allocation_view.sysml +5 -3
  32. package/examples/gpca-pump/model/catalog/viewpoints/functional/views/functional_function_browser_view.sysml +5 -3
  33. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/behavior_action_flow_view.sysml +5 -3
  34. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/document_architecture_description_view.sysml +5 -3
  35. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_device_interconnect_view.sysml +5 -3
  36. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_logical_architecture_view.sysml +5 -3
  37. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_mode_state_view.sysml +5 -3
  38. package/examples/gpca-pump/model/catalog/viewpoints/logical/views/logical_system_decomposition_view.sysml +5 -3
  39. package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_scenario_sequence_view.sysml +5 -3
  40. package/examples/gpca-pump/model/catalog/viewpoints/operational/views/operational_use_case_view.sysml +5 -3
  41. package/examples/gpca-pump/model/catalog/viewpoints/physical/views/physical_physical_bom_view.sysml +5 -3
  42. package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/document_dhf_index_view.sysml +5 -3
  43. package/examples/gpca-pump/model/catalog/viewpoints/requirements/views/requirements_requirements_trace_view.sysml +5 -3
  44. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_hazard_analysis_view.sysml +5 -3
  45. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/document_rmf_view.sysml +5 -3
  46. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_fmea_view.sysml +5 -3
  47. package/examples/gpca-pump/model/catalog/viewpoints/risk/views/risk_risk_chain_view.sysml +5 -3
  48. package/examples/gpca-pump/model/catalog/viewpoints/software/views/document_sdd_view.sysml +5 -3
  49. package/examples/gpca-pump/model/catalog/viewpoints/software/views/software_software_architecture_view.sysml +5 -3
  50. package/examples/gpca-pump/model/catalog/viewpoints/usability/views/document_usability_view.sysml +6 -4
  51. package/examples/gpca-pump/model/catalog/viewpoints/verification/views/document_vv_view.sysml +5 -3
  52. package/examples/gpca-pump/model/catalog/viewpoints/verification/views/verification_verification_coverage_view.sysml +5 -3
  53. package/examples/ivd-laboratory-system/model/catalog/ivd_laboratory_system.sysml +9 -7
  54. package/examples/ivd-laboratory-system/model/catalog/project.sysml +3 -1
  55. package/examples/manual-surgical-instrument/model/catalog/manual_surgical_instrument.sysml +6 -4
  56. package/examples/manual-surgical-instrument/model/catalog/project.sysml +3 -1
  57. package/examples/multidimensional-layers/model/catalog/multidimensional_layers.sysml +6 -4
  58. package/examples/multidimensional-layers/model/catalog/project.sysml +3 -1
  59. package/examples/nested-architecture-dsm/memo.identity.yaml +181 -0
  60. package/examples/nested-architecture-dsm/model/catalog/architecture/functional/functions.sysml +20 -18
  61. package/examples/nested-architecture-dsm/model/catalog/architecture/logical/structure.sysml +20 -18
  62. package/examples/nested-architecture-dsm/model/catalog/architecture/operational/context.sysml +34 -0
  63. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/needs.sysml +11 -6
  64. package/examples/nested-architecture-dsm/model/catalog/assurance/requirements/requirements.sysml +16 -14
  65. package/examples/nested-architecture-dsm/model/catalog/assurance/verification_validation/verification_validation.sysml +18 -16
  66. package/examples/nested-architecture-dsm/model/catalog/project.sysml +4 -1
  67. package/examples/reusable-instrument/model/catalog/project.sysml +3 -1
  68. package/examples/reusable-instrument/model/catalog/reusable_instrument.sysml +17 -16
  69. package/examples/ros-mobile-robot/model/catalog/project.sysml +3 -1
  70. package/examples/ros-mobile-robot/model/catalog/ros_mobile_robot.sysml +18 -16
  71. package/examples/software-only-medical-device/model/catalog/project.sysml +3 -1
  72. package/examples/software-only-medical-device/model/catalog/software_only_medical_device.sysml +10 -8
  73. package/examples/surgical-closure-workflow/model/catalog/project.sysml +3 -1
  74. package/examples/surgical-closure-workflow/model/catalog/surgical_closure_workflow.sysml +54 -51
  75. package/examples/surgical-robot/model/catalog/project.sysml +3 -1
  76. package/examples/surgical-robot/model/catalog/surgical_robot.sysml +9 -7
  77. package/examples/sysml-diagram-samples/model/catalog/project.sysml +3 -1
  78. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/action_flow_view.sysml +10 -8
  79. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/context_view.sysml +7 -5
  80. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/functional_flow_view.sysml +3 -1
  81. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/interconnection_view.sysml +2 -1
  82. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/operational_behaviour_view.sysml +3 -1
  83. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/requirements_view.sysml +11 -9
  84. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/standard_activity_view.sysml +3 -1
  85. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/state_transition_view.sysml +2 -1
  86. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/tree_view.sysml +3 -1
  87. package/examples/sysml-diagram-samples/model/catalog/viewpoints/unassigned/views/use_case_view.sysml +11 -7
  88. package/examples/temperature-alarm/memo.identity.yaml +64 -0
  89. package/examples/temperature-alarm/model/catalog/project.sysml +3 -1
  90. package/examples/temperature-alarm/model/catalog/temperature_alarm.sysml +27 -22
  91. package/examples/ui-screen-regions/memo.identity.yaml +205 -0
  92. package/examples/ui-screen-regions/model/catalog/architecture/functional/functions.sysml +14 -12
  93. package/examples/ui-screen-regions/model/catalog/architecture/implementation/ui.sysml +35 -33
  94. package/examples/ui-screen-regions/model/catalog/artifacts/assets/catalog.sysml +8 -6
  95. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/comments.sysml +14 -13
  96. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/notes.sysml +4 -2
  97. package/examples/ui-screen-regions/model/catalog/artifacts/reviews/rationales.sysml +4 -2
  98. package/examples/ui-screen-regions/model/catalog/assurance/human_factors/human_factors.sysml +12 -10
  99. package/examples/ui-screen-regions/model/catalog/assurance/requirements/needs.sysml +3 -1
  100. package/examples/ui-screen-regions/model/catalog/assurance/requirements/requirements.sysml +26 -24
  101. package/examples/ui-screen-regions/model/catalog/assurance/safety_risk/risk.sysml +17 -15
  102. package/examples/ui-screen-regions/model/catalog/assurance/verification_validation/verification_validation.sysml +10 -9
  103. package/examples/ui-screen-regions/model/catalog/project.sysml +3 -1
  104. package/examples/ui-screen-regions/model/catalog/relationships.sysml +2 -2
  105. package/examples/ui-screen-regions/model/catalog/traces.sysml +0 -2
  106. package/examples/ui-screen-regions/model/catalog/viewpoints/functional/views/ui_functional_tree.sysml +5 -3
  107. package/examples/ui-screen-regions/model/catalog/viewpoints/requirements/views/ui_requirements_trace.sysml +5 -3
  108. package/examples/ui-screen-regions/model/catalog/viewpoints/risk/views/ui_risk_chain.sysml +5 -3
  109. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/main_screen_layout.sysml +3 -1
  110. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/settings_screen_layout.sysml +3 -1
  111. package/examples/ui-screen-regions/model/catalog/viewpoints/ui_layout/views/ui_region_trace.sysml +3 -1
  112. package/extensions/aadl/memo.package.yaml +1 -1
  113. package/extensions/aadl/src/correspondence/memo_aadl_correspondence.sysml +23 -21
  114. package/extensions/aadl/src/methodology/aadl_methodology.sysml +3 -1
  115. package/extensions/clinical/src/methodology/clinical_methodology.sysml +3 -1
  116. package/extensions/cloud/memo.package.yaml +1 -1
  117. package/extensions/cloud/src/methodology/cloud_methodology.sysml +3 -1
  118. package/extensions/container/memo.package.yaml +1 -1
  119. package/extensions/container/src/methodology/container_methodology.sysml +3 -1
  120. package/extensions/messaging/memo.package.yaml +1 -1
  121. package/extensions/messaging/src/methodology/messaging_methodology.sysml +3 -1
  122. package/extensions/ros/memo.package.yaml +1 -1
  123. package/extensions/ros/src/methodology/ros_methodology.sysml +3 -1
  124. package/extensions/template/src/extension.sysml +3 -1
  125. package/methodologies/default/memo.package.yaml +1 -1
  126. package/methodologies/gpca/memo.package.yaml +1 -1
  127. package/ontology/memo.package.yaml +1 -1
  128. package/package.json +2 -2
  129. package/profile/memo.package.yaml +1 -1
  130. package/src/architecture/functional/behavior/memo_behavior.sysml +1 -1
  131. package/src/architecture/implementation/hardware/common/memo_hardware_common.sysml +12 -2
  132. package/src/architecture/implementation/software/runtime/memo_software_runtime.sysml +0 -11
  133. package/src/architecture/implementation/ui/memo_ui.sysml +0 -23
  134. package/src/architecture/logical/interfaces/memo_interfaces.sysml +3 -1
  135. package/src/architecture/operational/context/use_context/memo_use_context.sysml +3 -11
  136. package/src/architecture/operational/scenarios/memo_scenarios.sysml +1 -12
  137. package/src/architecture/operational/use_cases/memo_use_cases.sysml +7 -11
  138. package/src/architecture/operational/workflows/memo_workflows.sysml +0 -20
  139. package/src/architecture/realization/deployment/memo_deployment.sysml +16 -9
  140. package/src/architecture/realization/physical/memo_physical_architecture.sysml +8 -2
  141. package/src/artifacts/standards/cfr_21_820.sysml +80 -89
  142. package/src/artifacts/standards/fda_cybersecurity_2023.sysml +45 -49
  143. package/src/artifacts/standards/iec_60601_1.sysml +108 -121
  144. package/src/artifacts/standards/iec_60601_1_2.sysml +31 -33
  145. package/src/artifacts/standards/iec_60812.sysml +21 -22
  146. package/src/artifacts/standards/iec_62304.sysml +150 -169
  147. package/src/artifacts/standards/iec_62366_1.sysml +80 -89
  148. package/src/artifacts/standards/iec_81001_5_1.sysml +52 -57
  149. package/src/artifacts/standards/iso_13485.sysml +80 -89
  150. package/src/artifacts/standards/iso_14971.sysml +66 -73
  151. package/src/artifacts/standards/iso_iec_ieee_42010.sysml +15 -15
  152. package/src/artifacts/templates/dhf/iec-60601/hrs.md +6 -6
  153. package/src/artifacts/templates/dhf/iec-62304/srs.md +10 -10
  154. package/src/artifacts/templates/dhf/system/syrs.md +6 -6
  155. package/src/assurance/cybersecurity/memo_cybersecurity.sysml +0 -1
  156. package/src/assurance/human_factors/memo_human_factors.sysml +0 -1
  157. package/src/assurance/requirements/memo_requirements.sysml +20 -16
  158. package/src/assurance/requirements/needs/memo_needs.sysml +33 -5
  159. package/src/assurance/safety_risk/memo_risk.sysml +20 -0
  160. package/src/assurance/verification_validation/memo_assurance.sysml +7 -12
  161. package/src/core/common/memo_common.sysml +50 -50
  162. package/src/core/enumerations/memo_enumerations.sysml +1 -1
  163. package/src/core/relationships/memo_relationships.sysml +22 -49
  164. package/src/methodology/archetypes/memo_archetypes.sysml +10 -8
  165. package/src/methodology/core/memo_core.sysml +0 -10
  166. package/src/methodology/profiles/memo_profiles.sysml +18 -16
  167. package/src/rules/closure/closure_rules.sysml +58 -22
  168. package/src/rules/crosslayer/cross_layer_rules.sysml +5 -3
  169. package/src/rules/ontology/ontology_invariants.sysml +119 -35
  170. package/src/rules/quantitative/quantitative_rules.sysml +4 -2
  171. package/src/viewpoints/catalog/memo_viewpoint_catalog.sysml +29 -28
  172. package/src/viewpoints/clinical/clinical_viewpoint.sysml +4 -2
  173. package/src/viewpoints/context/context_viewpoint.sysml +5 -3
  174. package/src/viewpoints/context/views/system_context_view/system_context_view.sysml +5 -3
  175. package/src/viewpoints/cybersecurity/cybersecurity_viewpoint.sysml +4 -2
  176. package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +6 -16
  177. package/src/viewpoints/functional/functional_viewpoint.sysml +4 -2
  178. package/src/viewpoints/functional/views/function_allocation_view/function_allocation_view.sysml +5 -3
  179. package/src/viewpoints/functional/views/system_functional_tree_view/system_functional_tree_view.sysml +5 -3
  180. package/src/viewpoints/logical/logical_viewpoint.sysml +4 -2
  181. package/src/viewpoints/logical/views/logical_architecture_view/logical_architecture_view.sysml +5 -3
  182. package/src/viewpoints/operational/operational_viewpoint.sysml +4 -2
  183. package/src/viewpoints/operational/views/use_case_view/use_case_view.sysml +5 -3
  184. package/src/viewpoints/physical/physical_viewpoint.sysml +4 -2
  185. package/src/viewpoints/physical/views/network_topology_view/network_topology_view.sysml +5 -3
  186. package/src/viewpoints/physical/views/physical_bom_view/physical_bom_view.sysml +5 -3
  187. package/src/viewpoints/rendering/memo_rendering.sysml +220 -40
  188. package/src/viewpoints/requirements/requirements_viewpoint.sysml +4 -2
  189. package/src/viewpoints/requirements/views/requirements_traceability_view/requirements_traceability_view.sysml +5 -3
  190. package/src/viewpoints/risk/risk_viewpoint.sysml +4 -2
  191. package/src/viewpoints/risk/views/risk_chain_view/risk_chain_view.sysml +5 -3
  192. package/src/viewpoints/software/software_viewpoint.sysml +4 -2
  193. package/src/viewpoints/software/views/software_architecture_view/software_architecture_view.sysml +5 -3
  194. package/src/viewpoints/ui_layout/ui_layout_viewpoint.sysml +4 -2
  195. package/src/viewpoints/ui_layout/views/screen_layout_view/screen_layout_view.sysml +3 -1
  196. package/src/viewpoints/usability/usability_viewpoint.sysml +4 -2
  197. package/src/viewpoints/verification/verification_viewpoint.sysml +4 -2
  198. package/src/viewpoints/verification/views/verification_coverage_view/verification_coverage_view.sysml +5 -3
  199. package/templates/connected-device/model/catalog/project.sysml +3 -1
  200. package/templates/default/model/catalog/project.sysml +3 -1
  201. package/templates/infusion-pump/model/catalog/project.sysml +3 -1
  202. package/templates/monitoring-device/model/catalog/project.sysml +3 -1
  203. package/templates/samd/model/catalog/project.sysml +3 -1
@@ -10,104 +10,95 @@ package memo_artifacts_standards_iec_62366_1 {
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  private import memo_core_relationships::*;
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  private import memo_artifacts_standards_traceability::*;
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+ private import memo_core_common::*;
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+ private import memo_core_common::MemoIdentity;
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  item iec62366_1 : RegulatoryStandard {
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- attribute :>> id = "STD-IEC-62366-1";
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1"; }
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  attribute :>> name = "IEC62366_1";
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  attribute :>> designation = "IEC 62366-1:2015+AMD1:2020";
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  attribute :>> edition = "2015";
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  attribute :>> issuer = "IEC";
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  attribute :>> amendments = "AMD1:2020";
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  attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
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+ item iec62366_1Clause4 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-4"; }
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+ attribute :>> name = "IEC62366_1Clause4";
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+ attribute :>> clauseNumber = "4";
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+ attribute :>> title = "general requirements for the usability engineering process";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5"; }
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+ attribute :>> name = "IEC62366_1Clause5";
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+ attribute :>> clauseNumber = "5";
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+ attribute :>> title = "usability engineering process";
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+ attribute :>> normativeStrength = "shall";
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+ item iec62366_1Clause5_1 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-1"; }
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+ attribute :>> name = "IEC62366_1Clause5_1";
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+ attribute :>> clauseNumber = "5.1";
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+ attribute :>> title = "use specification";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_2 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-2"; }
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+ attribute :>> name = "IEC62366_1Clause5_2";
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+ attribute :>> clauseNumber = "5.2";
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+ attribute :>> title = "user interface characteristics related to safety";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_3 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-3"; }
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+ attribute :>> name = "IEC62366_1Clause5_3";
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+ attribute :>> clauseNumber = "5.3";
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+ attribute :>> title = "known and foreseeable use-related hazards";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_4 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-4"; }
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+ attribute :>> name = "IEC62366_1Clause5_4";
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+ attribute :>> clauseNumber = "5.4";
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+ attribute :>> title = "hazard-related use scenarios";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_5 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-5"; }
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+ attribute :>> name = "IEC62366_1Clause5_5";
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+ attribute :>> clauseNumber = "5.5";
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+ attribute :>> title = "selection of use scenarios for summative evaluation";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_6 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-6"; }
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+ attribute :>> name = "IEC62366_1Clause5_6";
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+ attribute :>> clauseNumber = "5.6";
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+ attribute :>> title = "user interface specification";
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+ attribute :>> normativeStrength = "shall";
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+ }
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+ item iec62366_1Clause5_7 : StandardClause {
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+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-7"; }
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+ attribute :>> name = "IEC62366_1Clause5_7";
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+ attribute :>> clauseNumber = "5.7";
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+ attribute :>> title = "user interface evaluation plan";
83
+ attribute :>> normativeStrength = "shall";
84
+ }
85
+ item iec62366_1Clause5_8 : StandardClause {
86
+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-8"; }
87
+ attribute :>> name = "IEC62366_1Clause5_8";
88
+ attribute :>> clauseNumber = "5.8";
89
+ attribute :>> title = "user interface design and formative evaluation";
90
+ attribute :>> normativeStrength = "shall";
91
+ }
92
+ item iec62366_1Clause5_9 : StandardClause {
93
+ @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-9"; }
94
+ attribute :>> name = "IEC62366_1Clause5_9";
95
+ attribute :>> clauseNumber = "5.9";
96
+ attribute :>> title = "summative evaluation of the user interface";
97
+ attribute :>> normativeStrength = "shall";
98
+ }
99
+ }
21
100
  }
22
101
 
23
- item iec62366_1Clause4 : StandardClause {
24
- attribute :>> id = "STD-IEC-62366-1-4";
25
- attribute :>> name = "IEC62366_1Clause4";
26
- attribute :>> clauseNumber = "4";
27
- attribute :>> title = "general requirements for the usability engineering process";
28
- attribute :>> normativeStrength = "shall";
29
- }
30
- item iec62366_1Clause5 : StandardClause {
31
- attribute :>> id = "STD-IEC-62366-1-5";
32
- attribute :>> name = "IEC62366_1Clause5";
33
- attribute :>> clauseNumber = "5";
34
- attribute :>> title = "usability engineering process";
35
- attribute :>> normativeStrength = "shall";
36
- }
37
- item iec62366_1Clause5_1 : StandardClause {
38
- attribute :>> id = "STD-IEC-62366-1-5-1";
39
- attribute :>> name = "IEC62366_1Clause5_1";
40
- attribute :>> clauseNumber = "5.1";
41
- attribute :>> title = "use specification";
42
- attribute :>> normativeStrength = "shall";
43
- }
44
- item iec62366_1Clause5_2 : StandardClause {
45
- attribute :>> id = "STD-IEC-62366-1-5-2";
46
- attribute :>> name = "IEC62366_1Clause5_2";
47
- attribute :>> clauseNumber = "5.2";
48
- attribute :>> title = "user interface characteristics related to safety";
49
- attribute :>> normativeStrength = "shall";
50
- }
51
- item iec62366_1Clause5_3 : StandardClause {
52
- attribute :>> id = "STD-IEC-62366-1-5-3";
53
- attribute :>> name = "IEC62366_1Clause5_3";
54
- attribute :>> clauseNumber = "5.3";
55
- attribute :>> title = "known and foreseeable use-related hazards";
56
- attribute :>> normativeStrength = "shall";
57
- }
58
- item iec62366_1Clause5_4 : StandardClause {
59
- attribute :>> id = "STD-IEC-62366-1-5-4";
60
- attribute :>> name = "IEC62366_1Clause5_4";
61
- attribute :>> clauseNumber = "5.4";
62
- attribute :>> title = "hazard-related use scenarios";
63
- attribute :>> normativeStrength = "shall";
64
- }
65
- item iec62366_1Clause5_5 : StandardClause {
66
- attribute :>> id = "STD-IEC-62366-1-5-5";
67
- attribute :>> name = "IEC62366_1Clause5_5";
68
- attribute :>> clauseNumber = "5.5";
69
- attribute :>> title = "selection of use scenarios for summative evaluation";
70
- attribute :>> normativeStrength = "shall";
71
- }
72
- item iec62366_1Clause5_6 : StandardClause {
73
- attribute :>> id = "STD-IEC-62366-1-5-6";
74
- attribute :>> name = "IEC62366_1Clause5_6";
75
- attribute :>> clauseNumber = "5.6";
76
- attribute :>> title = "user interface specification";
77
- attribute :>> normativeStrength = "shall";
78
- }
79
- item iec62366_1Clause5_7 : StandardClause {
80
- attribute :>> id = "STD-IEC-62366-1-5-7";
81
- attribute :>> name = "IEC62366_1Clause5_7";
82
- attribute :>> clauseNumber = "5.7";
83
- attribute :>> title = "user interface evaluation plan";
84
- attribute :>> normativeStrength = "shall";
85
- }
86
- item iec62366_1Clause5_8 : StandardClause {
87
- attribute :>> id = "STD-IEC-62366-1-5-8";
88
- attribute :>> name = "IEC62366_1Clause5_8";
89
- attribute :>> clauseNumber = "5.8";
90
- attribute :>> title = "user interface design and formative evaluation";
91
- attribute :>> normativeStrength = "shall";
92
- }
93
- item iec62366_1Clause5_9 : StandardClause {
94
- attribute :>> id = "STD-IEC-62366-1-5-9";
95
- attribute :>> name = "IEC62366_1Clause5_9";
96
- attribute :>> clauseNumber = "5.9";
97
- attribute :>> title = "summative evaluation of the user interface";
98
- attribute :>> normativeStrength = "shall";
99
- }
100
102
 
101
- connection iec62366_1Has4 : Composes connect parent ::> iec62366_1 to child ::> iec62366_1Clause4;
102
- connection iec62366_1Has5 : Composes connect parent ::> iec62366_1 to child ::> iec62366_1Clause5;
103
103
 
104
- connection iec62366_1Has5_1 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_1;
105
- connection iec62366_1Has5_2 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_2;
106
- connection iec62366_1Has5_3 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_3;
107
- connection iec62366_1Has5_4 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_4;
108
- connection iec62366_1Has5_5 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_5;
109
- connection iec62366_1Has5_6 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_6;
110
- connection iec62366_1Has5_7 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_7;
111
- connection iec62366_1Has5_8 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_8;
112
- connection iec62366_1Has5_9 : Composes connect parent ::> iec62366_1Clause5 to child ::> iec62366_1Clause5_9;
113
104
  }
@@ -8,77 +8,72 @@ package memo_artifacts_standards_iec_81001_5_1 {
8
8
  private import memo_core_relationships::*;
9
9
  private import memo_artifacts_standards_traceability::*;
10
10
 
11
+ private import memo_core_common::*;
12
+ private import memo_core_common::MemoIdentity;
11
13
  item iec81001_5_1 : RegulatoryStandard {
12
- attribute :>> id = "STD-IEC-81001-5-1";
14
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1"; }
13
15
  attribute :>> name = "IEC81001_5_1";
14
16
  attribute :>> designation = "IEC 81001-5-1:2021";
15
17
  attribute :>> edition = "2021";
16
18
  attribute :>> issuer = "IEC";
17
19
  attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
20
+ item iec81001_5_1Clause4 : StandardClause {
21
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-4"; }
22
+ attribute :>> name = "IEC81001_5_1Clause4";
23
+ attribute :>> clauseNumber = "4";
24
+ attribute :>> title = "general requirements";
25
+ attribute :>> normativeStrength = "shall";
26
+ }
27
+ item iec81001_5_1Clause5 : StandardClause {
28
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5"; }
29
+ attribute :>> name = "IEC81001_5_1Clause5";
30
+ attribute :>> clauseNumber = "5";
31
+ attribute :>> title = "software development process";
32
+ attribute :>> normativeStrength = "shall";
33
+ item iec81001_5_1Clause5_1 : StandardClause {
34
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-1"; }
35
+ attribute :>> name = "IEC81001_5_1Clause5_1";
36
+ attribute :>> clauseNumber = "5.1";
37
+ attribute :>> title = "software development planning";
38
+ attribute :>> normativeStrength = "shall";
39
+ }
40
+ item iec81001_5_1Clause5_2 : StandardClause {
41
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-2"; }
42
+ attribute :>> name = "IEC81001_5_1Clause5_2";
43
+ attribute :>> clauseNumber = "5.2";
44
+ attribute :>> title = "software requirements analysis";
45
+ attribute :>> normativeStrength = "shall";
46
+ }
47
+ item iec81001_5_1Clause5_3 : StandardClause {
48
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-3"; }
49
+ attribute :>> name = "IEC81001_5_1Clause5_3";
50
+ attribute :>> clauseNumber = "5.3";
51
+ attribute :>> title = "software architectural design";
52
+ attribute :>> normativeStrength = "shall";
53
+ }
54
+ item iec81001_5_1Clause5_4 : StandardClause {
55
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-4"; }
56
+ attribute :>> name = "IEC81001_5_1Clause5_4";
57
+ attribute :>> clauseNumber = "5.4";
58
+ attribute :>> title = "software design";
59
+ attribute :>> normativeStrength = "shall";
60
+ }
61
+ item iec81001_5_1Clause5_8 : StandardClause {
62
+ @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-8"; }
63
+ attribute :>> name = "IEC81001_5_1Clause5_8";
64
+ attribute :>> clauseNumber = "5.8";
65
+ attribute :>> title = "software release";
66
+ attribute :>> normativeStrength = "shall";
67
+ }
68
+ }
18
69
  }
19
70
 
20
- item iec81001_5_1Clause4 : StandardClause {
21
- attribute :>> id = "STD-IEC-81001-5-1-4";
22
- attribute :>> name = "IEC81001_5_1Clause4";
23
- attribute :>> clauseNumber = "4";
24
- attribute :>> title = "general requirements";
25
- attribute :>> normativeStrength = "shall";
26
- }
27
71
 
28
- item iec81001_5_1Clause5 : StandardClause {
29
- attribute :>> id = "STD-IEC-81001-5-1-5";
30
- attribute :>> name = "IEC81001_5_1Clause5";
31
- attribute :>> clauseNumber = "5";
32
- attribute :>> title = "software development process";
33
- attribute :>> normativeStrength = "shall";
34
- }
35
72
 
36
- item iec81001_5_1Clause5_1 : StandardClause {
37
- attribute :>> id = "STD-IEC-81001-5-1-5-1";
38
- attribute :>> name = "IEC81001_5_1Clause5_1";
39
- attribute :>> clauseNumber = "5.1";
40
- attribute :>> title = "software development planning";
41
- attribute :>> normativeStrength = "shall";
42
- }
43
73
 
44
- item iec81001_5_1Clause5_2 : StandardClause {
45
- attribute :>> id = "STD-IEC-81001-5-1-5-2";
46
- attribute :>> name = "IEC81001_5_1Clause5_2";
47
- attribute :>> clauseNumber = "5.2";
48
- attribute :>> title = "software requirements analysis";
49
- attribute :>> normativeStrength = "shall";
50
- }
51
74
 
52
- item iec81001_5_1Clause5_3 : StandardClause {
53
- attribute :>> id = "STD-IEC-81001-5-1-5-3";
54
- attribute :>> name = "IEC81001_5_1Clause5_3";
55
- attribute :>> clauseNumber = "5.3";
56
- attribute :>> title = "software architectural design";
57
- attribute :>> normativeStrength = "shall";
58
- }
59
75
 
60
- item iec81001_5_1Clause5_4 : StandardClause {
61
- attribute :>> id = "STD-IEC-81001-5-1-5-4";
62
- attribute :>> name = "IEC81001_5_1Clause5_4";
63
- attribute :>> clauseNumber = "5.4";
64
- attribute :>> title = "software design";
65
- attribute :>> normativeStrength = "shall";
66
- }
67
76
 
68
- item iec81001_5_1Clause5_8 : StandardClause {
69
- attribute :>> id = "STD-IEC-81001-5-1-5-8";
70
- attribute :>> name = "IEC81001_5_1Clause5_8";
71
- attribute :>> clauseNumber = "5.8";
72
- attribute :>> title = "software release";
73
- attribute :>> normativeStrength = "shall";
74
- }
75
77
 
76
- connection iec81001_5_1Has4 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause4;
77
- connection iec81001_5_1Has5 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause5;
78
78
 
79
- connection iec81001_5_1Has5_1 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_1;
80
- connection iec81001_5_1Has5_2 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_2;
81
- connection iec81001_5_1Has5_3 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_3;
82
- connection iec81001_5_1Has5_4 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_4;
83
- connection iec81001_5_1Has5_8 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_8;
84
79
  }
@@ -10,104 +10,95 @@ package memo_artifacts_standards_iso_13485 {
10
10
  private import memo_core_relationships::*;
11
11
  private import memo_artifacts_standards_traceability::*;
12
12
 
13
+ private import memo_core_common::*;
14
+ private import memo_core_common::MemoIdentity;
13
15
  item iso13485 : RegulatoryStandard {
14
- attribute :>> id = "STD-ISO-13485";
16
+ @MemoIdentity { :>> providedId = "STD-ISO-13485"; }
15
17
  attribute :>> name = "ISO13485";
16
18
  attribute :>> designation = "ISO 13485:2016";
17
19
  attribute :>> edition = "2016";
18
20
  attribute :>> issuer = "ISO";
19
21
  attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
22
+ item iso13485Clause4 : StandardClause {
23
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-4"; }
24
+ attribute :>> name = "ISO13485Clause4";
25
+ attribute :>> clauseNumber = "4";
26
+ attribute :>> title = "quality management system";
27
+ attribute :>> normativeStrength = "shall";
28
+ item iso13485Clause4_2 : StandardClause {
29
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2"; }
30
+ attribute :>> name = "ISO13485Clause4_2";
31
+ attribute :>> clauseNumber = "4.2";
32
+ attribute :>> title = "quality management system documentation";
33
+ attribute :>> normativeStrength = "shall";
34
+ item iso13485Clause4_2_4 : StandardClause {
35
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2-4"; }
36
+ attribute :>> name = "ISO13485Clause4_2_4";
37
+ attribute :>> clauseNumber = "4.2.4";
38
+ attribute :>> title = "control of documents";
39
+ attribute :>> normativeStrength = "shall";
40
+ }
41
+ }
42
+ }
43
+ item iso13485Clause7 : StandardClause {
44
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7"; }
45
+ attribute :>> name = "ISO13485Clause7";
46
+ attribute :>> clauseNumber = "7";
47
+ attribute :>> title = "product realization";
48
+ attribute :>> normativeStrength = "shall";
49
+ item iso13485Clause7_3 : StandardClause {
50
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3"; }
51
+ attribute :>> name = "ISO13485Clause7_3";
52
+ attribute :>> clauseNumber = "7.3";
53
+ attribute :>> title = "design and development";
54
+ attribute :>> normativeStrength = "shall";
55
+ item iso13485Clause7_3_3 : StandardClause {
56
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-3"; }
57
+ attribute :>> name = "ISO13485Clause7_3_3";
58
+ attribute :>> clauseNumber = "7.3.3";
59
+ attribute :>> title = "design and development inputs";
60
+ attribute :>> normativeStrength = "shall";
61
+ }
62
+ item iso13485Clause7_3_4 : StandardClause {
63
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-4"; }
64
+ attribute :>> name = "ISO13485Clause7_3_4";
65
+ attribute :>> clauseNumber = "7.3.4";
66
+ attribute :>> title = "design and development outputs";
67
+ attribute :>> normativeStrength = "shall";
68
+ }
69
+ item iso13485Clause7_3_6 : StandardClause {
70
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-6"; }
71
+ attribute :>> name = "ISO13485Clause7_3_6";
72
+ attribute :>> clauseNumber = "7.3.6";
73
+ attribute :>> title = "design and development verification";
74
+ attribute :>> normativeStrength = "shall";
75
+ }
76
+ item iso13485Clause7_3_7 : StandardClause {
77
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-7"; }
78
+ attribute :>> name = "ISO13485Clause7_3_7";
79
+ attribute :>> clauseNumber = "7.3.7";
80
+ attribute :>> title = "design and development validation";
81
+ attribute :>> normativeStrength = "shall";
82
+ }
83
+ item iso13485Clause7_3_9 : StandardClause {
84
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-9"; }
85
+ attribute :>> name = "ISO13485Clause7_3_9";
86
+ attribute :>> clauseNumber = "7.3.9";
87
+ attribute :>> title = "control of design and development changes";
88
+ attribute :>> normativeStrength = "shall";
89
+ }
90
+ item iso13485Clause7_3_10 : StandardClause {
91
+ @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-10"; }
92
+ attribute :>> name = "ISO13485Clause7_3_10";
93
+ attribute :>> clauseNumber = "7.3.10";
94
+ attribute :>> title = "design and development files";
95
+ attribute :>> normativeStrength = "shall";
96
+ }
97
+ }
98
+ }
20
99
  }
21
100
 
22
- item iso13485Clause4 : StandardClause {
23
- attribute :>> id = "STD-ISO-13485-4";
24
- attribute :>> name = "ISO13485Clause4";
25
- attribute :>> clauseNumber = "4";
26
- attribute :>> title = "quality management system";
27
- attribute :>> normativeStrength = "shall";
28
- }
29
- item iso13485Clause4_2 : StandardClause {
30
- attribute :>> id = "STD-ISO-13485-4-2";
31
- attribute :>> name = "ISO13485Clause4_2";
32
- attribute :>> clauseNumber = "4.2";
33
- attribute :>> title = "quality management system documentation";
34
- attribute :>> normativeStrength = "shall";
35
- }
36
- item iso13485Clause4_2_4 : StandardClause {
37
- attribute :>> id = "STD-ISO-13485-4-2-4";
38
- attribute :>> name = "ISO13485Clause4_2_4";
39
- attribute :>> clauseNumber = "4.2.4";
40
- attribute :>> title = "control of documents";
41
- attribute :>> normativeStrength = "shall";
42
- }
43
- item iso13485Clause7 : StandardClause {
44
- attribute :>> id = "STD-ISO-13485-7";
45
- attribute :>> name = "ISO13485Clause7";
46
- attribute :>> clauseNumber = "7";
47
- attribute :>> title = "product realization";
48
- attribute :>> normativeStrength = "shall";
49
- }
50
- item iso13485Clause7_3 : StandardClause {
51
- attribute :>> id = "STD-ISO-13485-7-3";
52
- attribute :>> name = "ISO13485Clause7_3";
53
- attribute :>> clauseNumber = "7.3";
54
- attribute :>> title = "design and development";
55
- attribute :>> normativeStrength = "shall";
56
- }
57
- item iso13485Clause7_3_3 : StandardClause {
58
- attribute :>> id = "STD-ISO-13485-7-3-3";
59
- attribute :>> name = "ISO13485Clause7_3_3";
60
- attribute :>> clauseNumber = "7.3.3";
61
- attribute :>> title = "design and development inputs";
62
- attribute :>> normativeStrength = "shall";
63
- }
64
- item iso13485Clause7_3_4 : StandardClause {
65
- attribute :>> id = "STD-ISO-13485-7-3-4";
66
- attribute :>> name = "ISO13485Clause7_3_4";
67
- attribute :>> clauseNumber = "7.3.4";
68
- attribute :>> title = "design and development outputs";
69
- attribute :>> normativeStrength = "shall";
70
- }
71
- item iso13485Clause7_3_6 : StandardClause {
72
- attribute :>> id = "STD-ISO-13485-7-3-6";
73
- attribute :>> name = "ISO13485Clause7_3_6";
74
- attribute :>> clauseNumber = "7.3.6";
75
- attribute :>> title = "design and development verification";
76
- attribute :>> normativeStrength = "shall";
77
- }
78
- item iso13485Clause7_3_7 : StandardClause {
79
- attribute :>> id = "STD-ISO-13485-7-3-7";
80
- attribute :>> name = "ISO13485Clause7_3_7";
81
- attribute :>> clauseNumber = "7.3.7";
82
- attribute :>> title = "design and development validation";
83
- attribute :>> normativeStrength = "shall";
84
- }
85
- item iso13485Clause7_3_9 : StandardClause {
86
- attribute :>> id = "STD-ISO-13485-7-3-9";
87
- attribute :>> name = "ISO13485Clause7_3_9";
88
- attribute :>> clauseNumber = "7.3.9";
89
- attribute :>> title = "control of design and development changes";
90
- attribute :>> normativeStrength = "shall";
91
- }
92
- item iso13485Clause7_3_10 : StandardClause {
93
- attribute :>> id = "STD-ISO-13485-7-3-10";
94
- attribute :>> name = "ISO13485Clause7_3_10";
95
- attribute :>> clauseNumber = "7.3.10";
96
- attribute :>> title = "design and development files";
97
- attribute :>> normativeStrength = "shall";
98
- }
99
101
 
100
- connection iso13485Has4 : Composes connect parent ::> iso13485 to child ::> iso13485Clause4;
101
- connection iso13485Has7 : Composes connect parent ::> iso13485 to child ::> iso13485Clause7;
102
102
 
103
- connection iso13485Has4_2 : Composes connect parent ::> iso13485Clause4 to child ::> iso13485Clause4_2;
104
- connection iso13485Has4_2_4 : Composes connect parent ::> iso13485Clause4_2 to child ::> iso13485Clause4_2_4;
105
103
 
106
- connection iso13485Has7_3 : Composes connect parent ::> iso13485Clause7 to child ::> iso13485Clause7_3;
107
- connection iso13485Has7_3_3 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_3;
108
- connection iso13485Has7_3_4 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_4;
109
- connection iso13485Has7_3_6 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_6;
110
- connection iso13485Has7_3_7 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_7;
111
- connection iso13485Has7_3_9 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_9;
112
- connection iso13485Has7_3_10 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_10;
113
104
  }
@@ -8,87 +8,80 @@ package memo_artifacts_standards_iso_14971 {
8
8
  private import memo_core_relationships::*;
9
9
  private import memo_artifacts_standards_traceability::*;
10
10
 
11
+ private import memo_core_common::*;
12
+ private import memo_core_common::MemoIdentity;
11
13
  item iso14971 : RegulatoryStandard {
12
- attribute :>> id = "STD-ISO-14971";
14
+ @MemoIdentity { :>> providedId = "STD-ISO-14971"; }
13
15
  attribute :>> name = "ISO14971";
14
16
  attribute :>> designation = "ISO 14971:2019";
15
17
  attribute :>> edition = "2019";
16
18
  attribute :>> issuer = "ISO";
17
19
  attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
20
+ item iso14971Clause4 : StandardClause {
21
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-4"; }
22
+ attribute :>> name = "ISO14971Clause4";
23
+ attribute :>> clauseNumber = "4";
24
+ attribute :>> title = "general requirements for the risk management system";
25
+ attribute :>> normativeStrength = "shall";
26
+ item iso14971Clause4_4 : StandardClause {
27
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-4-4"; }
28
+ attribute :>> name = "ISO14971Clause4_4";
29
+ attribute :>> clauseNumber = "4.4";
30
+ attribute :>> title = "risk management plan";
31
+ attribute :>> normativeStrength = "shall";
32
+ }
33
+ item iso14971Clause4_5 : StandardClause {
34
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-4-5"; }
35
+ attribute :>> name = "ISO14971Clause4_5";
36
+ attribute :>> clauseNumber = "4.5";
37
+ attribute :>> title = "risk management file";
38
+ attribute :>> normativeStrength = "shall";
39
+ }
40
+ }
41
+ item iso14971Clause5 : StandardClause {
42
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-5"; }
43
+ attribute :>> name = "ISO14971Clause5";
44
+ attribute :>> clauseNumber = "5";
45
+ attribute :>> title = "risk analysis";
46
+ attribute :>> normativeStrength = "shall";
47
+ }
48
+ item iso14971Clause6 : StandardClause {
49
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-6"; }
50
+ attribute :>> name = "ISO14971Clause6";
51
+ attribute :>> clauseNumber = "6";
52
+ attribute :>> title = "risk evaluation";
53
+ attribute :>> normativeStrength = "shall";
54
+ }
55
+ item iso14971Clause7 : StandardClause {
56
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-7"; }
57
+ attribute :>> name = "ISO14971Clause7";
58
+ attribute :>> clauseNumber = "7";
59
+ attribute :>> title = "risk control";
60
+ attribute :>> normativeStrength = "shall";
61
+ }
62
+ item iso14971Clause8 : StandardClause {
63
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-8"; }
64
+ attribute :>> name = "ISO14971Clause8";
65
+ attribute :>> clauseNumber = "8";
66
+ attribute :>> title = "evaluation of overall residual risk";
67
+ attribute :>> normativeStrength = "shall";
68
+ }
69
+ item iso14971Clause9 : StandardClause {
70
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-9"; }
71
+ attribute :>> name = "ISO14971Clause9";
72
+ attribute :>> clauseNumber = "9";
73
+ attribute :>> title = "risk management review";
74
+ attribute :>> normativeStrength = "shall";
75
+ }
76
+ item iso14971Clause10 : StandardClause {
77
+ @MemoIdentity { :>> providedId = "STD-ISO-14971-10"; }
78
+ attribute :>> name = "ISO14971Clause10";
79
+ attribute :>> clauseNumber = "10";
80
+ attribute :>> title = "production and post-production activities";
81
+ attribute :>> normativeStrength = "shall";
82
+ }
18
83
  }
19
84
 
20
- item iso14971Clause4 : StandardClause {
21
- attribute :>> id = "STD-ISO-14971-4";
22
- attribute :>> name = "ISO14971Clause4";
23
- attribute :>> clauseNumber = "4";
24
- attribute :>> title = "general requirements for the risk management system";
25
- attribute :>> normativeStrength = "shall";
26
- }
27
- item iso14971Clause4_4 : StandardClause {
28
- attribute :>> id = "STD-ISO-14971-4-4";
29
- attribute :>> name = "ISO14971Clause4_4";
30
- attribute :>> clauseNumber = "4.4";
31
- attribute :>> title = "risk management plan";
32
- attribute :>> normativeStrength = "shall";
33
- }
34
- item iso14971Clause4_5 : StandardClause {
35
- attribute :>> id = "STD-ISO-14971-4-5";
36
- attribute :>> name = "ISO14971Clause4_5";
37
- attribute :>> clauseNumber = "4.5";
38
- attribute :>> title = "risk management file";
39
- attribute :>> normativeStrength = "shall";
40
- }
41
- item iso14971Clause5 : StandardClause {
42
- attribute :>> id = "STD-ISO-14971-5";
43
- attribute :>> name = "ISO14971Clause5";
44
- attribute :>> clauseNumber = "5";
45
- attribute :>> title = "risk analysis";
46
- attribute :>> normativeStrength = "shall";
47
- }
48
- item iso14971Clause6 : StandardClause {
49
- attribute :>> id = "STD-ISO-14971-6";
50
- attribute :>> name = "ISO14971Clause6";
51
- attribute :>> clauseNumber = "6";
52
- attribute :>> title = "risk evaluation";
53
- attribute :>> normativeStrength = "shall";
54
- }
55
- item iso14971Clause7 : StandardClause {
56
- attribute :>> id = "STD-ISO-14971-7";
57
- attribute :>> name = "ISO14971Clause7";
58
- attribute :>> clauseNumber = "7";
59
- attribute :>> title = "risk control";
60
- attribute :>> normativeStrength = "shall";
61
- }
62
- item iso14971Clause8 : StandardClause {
63
- attribute :>> id = "STD-ISO-14971-8";
64
- attribute :>> name = "ISO14971Clause8";
65
- attribute :>> clauseNumber = "8";
66
- attribute :>> title = "evaluation of overall residual risk";
67
- attribute :>> normativeStrength = "shall";
68
- }
69
- item iso14971Clause9 : StandardClause {
70
- attribute :>> id = "STD-ISO-14971-9";
71
- attribute :>> name = "ISO14971Clause9";
72
- attribute :>> clauseNumber = "9";
73
- attribute :>> title = "risk management review";
74
- attribute :>> normativeStrength = "shall";
75
- }
76
- item iso14971Clause10 : StandardClause {
77
- attribute :>> id = "STD-ISO-14971-10";
78
- attribute :>> name = "ISO14971Clause10";
79
- attribute :>> clauseNumber = "10";
80
- attribute :>> title = "production and post-production activities";
81
- attribute :>> normativeStrength = "shall";
82
- }
83
85
 
84
- connection iso14971Has4 : Composes connect parent ::> iso14971 to child ::> iso14971Clause4;
85
- connection iso14971Has5 : Composes connect parent ::> iso14971 to child ::> iso14971Clause5;
86
- connection iso14971Has6 : Composes connect parent ::> iso14971 to child ::> iso14971Clause6;
87
- connection iso14971Has7 : Composes connect parent ::> iso14971 to child ::> iso14971Clause7;
88
- connection iso14971Has8 : Composes connect parent ::> iso14971 to child ::> iso14971Clause8;
89
- connection iso14971Has9 : Composes connect parent ::> iso14971 to child ::> iso14971Clause9;
90
- connection iso14971Has10 : Composes connect parent ::> iso14971 to child ::> iso14971Clause10;
91
86
 
92
- connection iso14971Has4_4 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_4;
93
- connection iso14971Has4_5 : Composes connect parent ::> iso14971Clause4 to child ::> iso14971Clause4_5;
94
87
  }