npm - @memoarchitect/ontology - Versions diffs - 0.12.1 → 0.15.0 - Mend

@memoarchitect/ontology 0.12.1 → 0.15.0

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Files changed (317) hide show

package/src/artifacts/standards/iec_62366_1.sysml CHANGED Viewed

@@ -12,86 +12,74 @@ package memo_artifacts_standards_iec_62366_1 {
     private import memo_core_common::*;
     private import memo_core_common::MemoIdentity;
-    item iec62366_1 : RegulatoryStandard {
+    part iec62366_1 : RegulatoryStandard {
         @MemoIdentity { :>> providedId = "STD-IEC-62366-1"; }
-        attribute :>> name = "IEC62366_1";
         attribute :>> designation = "IEC 62366-1:2015+AMD1:2020";
         attribute :>> edition = "2015";
         attribute :>> issuer = "IEC";
         attribute :>> amendments = "AMD1:2020";
         attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
-        item iec62366_1Clause4 : StandardClause {
+        part iec62366_1Clause4 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-IEC-62366-1-4"; }
-            attribute :>> name = "IEC62366_1Clause4";
             attribute :>> clauseNumber = "4";
             attribute :>> title = "general requirements for the usability engineering process";
             attribute :>> normativeStrength = "shall";
         }
-        item iec62366_1Clause5 : StandardClause {
+        part iec62366_1Clause5 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5"; }
-            attribute :>> name = "IEC62366_1Clause5";
             attribute :>> clauseNumber = "5";
             attribute :>> title = "usability engineering process";
             attribute :>> normativeStrength = "shall";
-            item iec62366_1Clause5_1 : StandardClause {
+            part iec62366_1Clause5_1 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-1"; }
-                attribute :>> name = "IEC62366_1Clause5_1";
                 attribute :>> clauseNumber = "5.1";
                 attribute :>> title = "use specification";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_2 : StandardClause {
+            part iec62366_1Clause5_2 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-2"; }
-                attribute :>> name = "IEC62366_1Clause5_2";
                 attribute :>> clauseNumber = "5.2";
                 attribute :>> title = "user interface characteristics related to safety";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_3 : StandardClause {
+            part iec62366_1Clause5_3 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-3"; }
-                attribute :>> name = "IEC62366_1Clause5_3";
                 attribute :>> clauseNumber = "5.3";
                 attribute :>> title = "known and foreseeable use-related hazards";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_4 : StandardClause {
+            part iec62366_1Clause5_4 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-4"; }
-                attribute :>> name = "IEC62366_1Clause5_4";
                 attribute :>> clauseNumber = "5.4";
                 attribute :>> title = "hazard-related use scenarios";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_5 : StandardClause {
+            part iec62366_1Clause5_5 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-5"; }
-                attribute :>> name = "IEC62366_1Clause5_5";
                 attribute :>> clauseNumber = "5.5";
                 attribute :>> title = "selection of use scenarios for summative evaluation";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_6 : StandardClause {
+            part iec62366_1Clause5_6 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-6"; }
-                attribute :>> name = "IEC62366_1Clause5_6";
                 attribute :>> clauseNumber = "5.6";
                 attribute :>> title = "user interface specification";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_7 : StandardClause {
+            part iec62366_1Clause5_7 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-7"; }
-                attribute :>> name = "IEC62366_1Clause5_7";
                 attribute :>> clauseNumber = "5.7";
                 attribute :>> title = "user interface evaluation plan";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_8 : StandardClause {
+            part iec62366_1Clause5_8 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-8"; }
-                attribute :>> name = "IEC62366_1Clause5_8";
                 attribute :>> clauseNumber = "5.8";
                 attribute :>> title = "user interface design and formative evaluation";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec62366_1Clause5_9 : StandardClause {
+            part iec62366_1Clause5_9 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-9"; }
-                attribute :>> name = "IEC62366_1Clause5_9";
                 attribute :>> clauseNumber = "5.9";
                 attribute :>> title = "summative evaluation of the user interface";
                 attribute :>> normativeStrength = "shall";

package/src/artifacts/standards/iec_81001_5_1.sysml CHANGED Viewed

@@ -10,57 +10,49 @@ package memo_artifacts_standards_iec_81001_5_1 {
     private import memo_core_common::*;
     private import memo_core_common::MemoIdentity;
-    item iec81001_5_1 : RegulatoryStandard {
+    part iec81001_5_1 : RegulatoryStandard {
         @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1"; }
-        attribute :>> name = "IEC81001_5_1";
         attribute :>> designation = "IEC 81001-5-1:2021";
         attribute :>> edition = "2021";
         attribute :>> issuer = "IEC";
         attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
-        item iec81001_5_1Clause4 : StandardClause {
+        part iec81001_5_1Clause4 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-4"; }
-            attribute :>> name = "IEC81001_5_1Clause4";
             attribute :>> clauseNumber = "4";
             attribute :>> title = "general requirements";
             attribute :>> normativeStrength = "shall";
         }
-        item iec81001_5_1Clause5 : StandardClause {
+        part iec81001_5_1Clause5 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5"; }
-            attribute :>> name = "IEC81001_5_1Clause5";
             attribute :>> clauseNumber = "5";
             attribute :>> title = "software development process";
             attribute :>> normativeStrength = "shall";
-            item iec81001_5_1Clause5_1 : StandardClause {
+            part iec81001_5_1Clause5_1 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-1"; }
-                attribute :>> name = "IEC81001_5_1Clause5_1";
                 attribute :>> clauseNumber = "5.1";
                 attribute :>> title = "software development planning";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec81001_5_1Clause5_2 : StandardClause {
+            part iec81001_5_1Clause5_2 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-2"; }
-                attribute :>> name = "IEC81001_5_1Clause5_2";
                 attribute :>> clauseNumber = "5.2";
                 attribute :>> title = "software requirements analysis";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec81001_5_1Clause5_3 : StandardClause {
+            part iec81001_5_1Clause5_3 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-3"; }
-                attribute :>> name = "IEC81001_5_1Clause5_3";
                 attribute :>> clauseNumber = "5.3";
                 attribute :>> title = "software architectural design";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec81001_5_1Clause5_4 : StandardClause {
+            part iec81001_5_1Clause5_4 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-4"; }
-                attribute :>> name = "IEC81001_5_1Clause5_4";
                 attribute :>> clauseNumber = "5.4";
                 attribute :>> title = "software design";
                 attribute :>> normativeStrength = "shall";
             }
-            item iec81001_5_1Clause5_8 : StandardClause {
+            part iec81001_5_1Clause5_8 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-IEC-81001-5-1-5-8"; }
-                attribute :>> name = "IEC81001_5_1Clause5_8";
                 attribute :>> clauseNumber = "5.8";
                 attribute :>> title = "software release";
                 attribute :>> normativeStrength = "shall";

package/src/artifacts/standards/iso_13485.sysml CHANGED Viewed

@@ -12,84 +12,72 @@ package memo_artifacts_standards_iso_13485 {
     private import memo_core_common::*;
     private import memo_core_common::MemoIdentity;
-    item iso13485 : RegulatoryStandard {
+    part iso13485 : RegulatoryStandard {
         @MemoIdentity { :>> providedId = "STD-ISO-13485"; }
-        attribute :>> name = "ISO13485";
         attribute :>> designation = "ISO 13485:2016";
         attribute :>> edition = "2016";
         attribute :>> issuer = "ISO";
         attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
-        item iso13485Clause4 : StandardClause {
+        part iso13485Clause4 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-13485-4"; }
-            attribute :>> name = "ISO13485Clause4";
             attribute :>> clauseNumber = "4";
             attribute :>> title = "quality management system";
             attribute :>> normativeStrength = "shall";
-            item iso13485Clause4_2 : StandardClause {
+            part iso13485Clause4_2 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2"; }
-                attribute :>> name = "ISO13485Clause4_2";
                 attribute :>> clauseNumber = "4.2";
                 attribute :>> title = "quality management system documentation";
                 attribute :>> normativeStrength = "shall";
-                item iso13485Clause4_2_4 : StandardClause {
+                part iso13485Clause4_2_4 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2-4"; }
-                    attribute :>> name = "ISO13485Clause4_2_4";
                     attribute :>> clauseNumber = "4.2.4";
                     attribute :>> title = "control of documents";
                     attribute :>> normativeStrength = "shall";
                 }
             }
         }
-        item iso13485Clause7 : StandardClause {
+        part iso13485Clause7 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-13485-7"; }
-            attribute :>> name = "ISO13485Clause7";
             attribute :>> clauseNumber = "7";
             attribute :>> title = "product realization";
             attribute :>> normativeStrength = "shall";
-            item iso13485Clause7_3 : StandardClause {
+            part iso13485Clause7_3 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3"; }
-                attribute :>> name = "ISO13485Clause7_3";
                 attribute :>> clauseNumber = "7.3";
                 attribute :>> title = "design and development";
                 attribute :>> normativeStrength = "shall";
-                item iso13485Clause7_3_3 : StandardClause {
+                part iso13485Clause7_3_3 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-3"; }
-                    attribute :>> name = "ISO13485Clause7_3_3";
                     attribute :>> clauseNumber = "7.3.3";
                     attribute :>> title = "design and development inputs";
                     attribute :>> normativeStrength = "shall";
                 }
-                item iso13485Clause7_3_4 : StandardClause {
+                part iso13485Clause7_3_4 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-4"; }
-                    attribute :>> name = "ISO13485Clause7_3_4";
                     attribute :>> clauseNumber = "7.3.4";
                     attribute :>> title = "design and development outputs";
                     attribute :>> normativeStrength = "shall";
                 }
-                item iso13485Clause7_3_6 : StandardClause {
+                part iso13485Clause7_3_6 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-6"; }
-                    attribute :>> name = "ISO13485Clause7_3_6";
                     attribute :>> clauseNumber = "7.3.6";
                     attribute :>> title = "design and development verification";
                     attribute :>> normativeStrength = "shall";
                 }
-                item iso13485Clause7_3_7 : StandardClause {
+                part iso13485Clause7_3_7 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-7"; }
-                    attribute :>> name = "ISO13485Clause7_3_7";
                     attribute :>> clauseNumber = "7.3.7";
                     attribute :>> title = "design and development validation";
                     attribute :>> normativeStrength = "shall";
                 }
-                item iso13485Clause7_3_9 : StandardClause {
+                part iso13485Clause7_3_9 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-9"; }
-                    attribute :>> name = "ISO13485Clause7_3_9";
                     attribute :>> clauseNumber = "7.3.9";
                     attribute :>> title = "control of design and development changes";
                     attribute :>> normativeStrength = "shall";
                 }
-                item iso13485Clause7_3_10 : StandardClause {
+                part iso13485Clause7_3_10 : StandardClause {
                     @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-10"; }
-                    attribute :>> name = "ISO13485Clause7_3_10";
                     attribute :>> clauseNumber = "7.3.10";
                     attribute :>> title = "design and development files";
                     attribute :>> normativeStrength = "shall";

package/src/artifacts/standards/iso_14971.sysml CHANGED Viewed

@@ -10,75 +10,173 @@ package memo_artifacts_standards_iso_14971 {
     private import memo_core_common::*;
     private import memo_core_common::MemoIdentity;
-    item iso14971 : RegulatoryStandard {
+    part iso14971 : RegulatoryStandard {
         @MemoIdentity { :>> providedId = "STD-ISO-14971"; }
-        attribute :>> name = "ISO14971";
         attribute :>> designation = "ISO 14971:2019";
         attribute :>> edition = "2019";
         attribute :>> issuer = "ISO";
         attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
-        item iso14971Clause4 : StandardClause {
+        part iso14971Clause4 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-4"; }
-            attribute :>> name = "ISO14971Clause4";
             attribute :>> clauseNumber = "4";
             attribute :>> title = "general requirements for the risk management system";
             attribute :>> normativeStrength = "shall";
-            item iso14971Clause4_4 : StandardClause {
+            part iso14971Clause4_1 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-4-1"; }
+                attribute :>> clauseNumber = "4.1";
+                attribute :>> title = "risk management process";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause4_2 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-4-2"; }
+                attribute :>> clauseNumber = "4.2";
+                attribute :>> title = "management responsibilities";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause4_3 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-4-3"; }
+                attribute :>> clauseNumber = "4.3";
+                attribute :>> title = "competence of personnel";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause4_4 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-ISO-14971-4-4"; }
-                attribute :>> name = "ISO14971Clause4_4";
                 attribute :>> clauseNumber = "4.4";
                 attribute :>> title = "risk management plan";
                 attribute :>> normativeStrength = "shall";
             }
-            item iso14971Clause4_5 : StandardClause {
+            part iso14971Clause4_5 : StandardClause {
                 @MemoIdentity { :>> providedId = "STD-ISO-14971-4-5"; }
-                attribute :>> name = "ISO14971Clause4_5";
                 attribute :>> clauseNumber = "4.5";
                 attribute :>> title = "risk management file";
                 attribute :>> normativeStrength = "shall";
             }
         }
-        item iso14971Clause5 : StandardClause {
+        part iso14971Clause5 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-5"; }
-            attribute :>> name = "ISO14971Clause5";
             attribute :>> clauseNumber = "5";
             attribute :>> title = "risk analysis";
             attribute :>> normativeStrength = "shall";
+            part iso14971Clause5_1 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-5-1"; }
+                attribute :>> clauseNumber = "5.1";
+                attribute :>> title = "risk analysis process";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause5_2 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-5-2"; }
+                attribute :>> clauseNumber = "5.2";
+                attribute :>> title = "intended use and reasonably foreseeable misuse";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause5_3 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-5-3"; }
+                attribute :>> clauseNumber = "5.3";
+                attribute :>> title = "safety characteristics";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause5_4 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-5-4"; }
+                attribute :>> clauseNumber = "5.4";
+                attribute :>> title = "hazards and hazardous situations";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause5_5 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-5-5"; }
+                attribute :>> clauseNumber = "5.5";
+                attribute :>> title = "risk estimation";
+                attribute :>> normativeStrength = "shall";
+            }
         }
-        item iso14971Clause6 : StandardClause {
+        part iso14971Clause6 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-6"; }
-            attribute :>> name = "ISO14971Clause6";
             attribute :>> clauseNumber = "6";
             attribute :>> title = "risk evaluation";
             attribute :>> normativeStrength = "shall";
         }
-        item iso14971Clause7 : StandardClause {
+        part iso14971Clause7 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-7"; }
-            attribute :>> name = "ISO14971Clause7";
             attribute :>> clauseNumber = "7";
             attribute :>> title = "risk control";
             attribute :>> normativeStrength = "shall";
+            part iso14971Clause7_1 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-1"; }
+                attribute :>> clauseNumber = "7.1";
+                attribute :>> title = "risk control option analysis";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause7_2 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-2"; }
+                attribute :>> clauseNumber = "7.2";
+                attribute :>> title = "implementation of risk control measures and verification of their effectiveness";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause7_3 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-3"; }
+                attribute :>> clauseNumber = "7.3";
+                attribute :>> title = "residual risk evaluation";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause7_4 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-4"; }
+                attribute :>> clauseNumber = "7.4";
+                attribute :>> title = "benefit-risk analysis";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause7_5 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-5"; }
+                attribute :>> clauseNumber = "7.5";
+                attribute :>> title = "risks arising from risk control measures";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause7_6 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-7-6"; }
+                attribute :>> clauseNumber = "7.6";
+                attribute :>> title = "completeness of risk control";
+                attribute :>> normativeStrength = "shall";
+            }
         }
-        item iso14971Clause8 : StandardClause {
+        part iso14971Clause8 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-8"; }
-            attribute :>> name = "ISO14971Clause8";
             attribute :>> clauseNumber = "8";
             attribute :>> title = "evaluation of overall residual risk";
             attribute :>> normativeStrength = "shall";
         }
-        item iso14971Clause9 : StandardClause {
+        part iso14971Clause9 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-9"; }
-            attribute :>> name = "ISO14971Clause9";
             attribute :>> clauseNumber = "9";
             attribute :>> title = "risk management review";
             attribute :>> normativeStrength = "shall";
         }
-        item iso14971Clause10 : StandardClause {
+        part iso14971Clause10 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-14971-10"; }
-            attribute :>> name = "ISO14971Clause10";
             attribute :>> clauseNumber = "10";
             attribute :>> title = "production and post-production activities";
             attribute :>> normativeStrength = "shall";
+            part iso14971Clause10_1 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-10-1"; }
+                attribute :>> clauseNumber = "10.1";
+                attribute :>> title = "production and post-production activities in general";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause10_2 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-10-2"; }
+                attribute :>> clauseNumber = "10.2";
+                attribute :>> title = "information collection";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause10_3 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-10-3"; }
+                attribute :>> clauseNumber = "10.3";
+                attribute :>> title = "information review";
+                attribute :>> normativeStrength = "shall";
+            }
+            part iso14971Clause10_4 : StandardClause {
+                @MemoIdentity { :>> providedId = "STD-ISO-14971-10-4"; }
+                attribute :>> clauseNumber = "10.4";
+                attribute :>> title = "actions";
+                attribute :>> normativeStrength = "shall";
+            }
         }
     }

package/src/artifacts/standards/iso_iec_ieee_42010.sysml CHANGED Viewed

@@ -14,9 +14,8 @@ package memo_artifacts_standards_iso_iec_ieee_42010 {
     private import memo_core_common::*;
     private import memo_core_common::MemoIdentity;
-    item isoIecIeee42010 : RegulatoryStandard {
+    part isoIecIeee42010 : RegulatoryStandard {
         @MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010"; }
-        attribute :>> name = "ISOIECIEEE42010";
         attribute :>> designation = "ISO/IEC/IEEE 42010:2022";
         attribute :>> edition = "2022";
         attribute :>> issuer = "ISO/IEC/IEEE";
@@ -24,15 +23,13 @@ package memo_artifacts_standards_iso_iec_ieee_42010 {
         // reference standard, cited by documents rather than required by a
         // market. Empty is the authored value, not an omission — see
         // appliesToRegime in memo_artifacts_standards_traceability.
-        item isoIecIeee42010Clause5 : StandardClause {
+        part isoIecIeee42010Clause5 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010-5"; }
-            attribute :>> name = "ISOIECIEEE42010Clause5";
             attribute :>> clauseNumber = "5";
             attribute :>> normativeStrength = "shall";
         }
-        item isoIecIeee42010Clause6 : StandardClause {
+        part isoIecIeee42010Clause6 : StandardClause {
             @MemoIdentity { :>> providedId = "STD-ISO-IEC-IEEE-42010-6"; }
-            attribute :>> name = "ISOIECIEEE42010Clause6";
             attribute :>> clauseNumber = "6";
             attribute :>> normativeStrength = "shall";
         }

package/src/artifacts/standards/memo_artifacts_standards_traceability.sysml CHANGED Viewed

@@ -48,7 +48,7 @@ package memo_artifacts_standards_traceability {
     // Standards and clauses
     // =========================================================================
-    item def RegulatoryStandard :> MemoArtifactItem {
+    part def RegulatoryStandard :> MemoArtifact {
         doc /* A regulatory or consensus standard a project claims conformance
              * to, identified by its full designation including edition and
              * amendments (e.g. "IEC 62366-1:2015+AMD1:2020"). Dropping the
@@ -73,7 +73,7 @@ package memo_artifacts_standards_traceability {
         attribute appliesToRegime : RegulatoryRegimeKind[0..*];
     }
-    item def StandardClause :> MemoArtifactItem {
+    part def StandardClause :> MemoArtifact {
         doc /* One normative clause of a RegulatoryStandard, at the depth at
              * which the standard makes a distinct requirement a MEMO document
              * actually claims. `title` is a MEMO-authored scope phrase — a
@@ -101,7 +101,10 @@ package memo_artifacts_standards_traceability {
         doc /* Any model element claims conformance to a standard clause.
              * This is the edge the standards traceability matrix and the
              * clause coverage report are computed over. */
-        end conformingElement : MemoPart :>> source;
+        // Untyped, as the doc above says. A requirement conforming to a
+        // clause is the commonest case and is not a part, so `MemoPart` here
+        // rejected most of what the matrix exists to show.
+        end conformingElement :>> source;
         end clause : StandardClause :>> target;
     }
     abstract connection conformsToLinks : ConformsTo[*];
@@ -120,7 +123,7 @@ package memo_artifacts_standards_traceability {
              * granularity rides on the link as a reference string rather than
              * as a duplicate element type. */
         attribute sectionReference : String[0..1];
-        end tracedElement : MemoPart :>> source;
+        end tracedElement : MemoArtifact :>> source;
         end artifact : ControlledArtifact :>> target;
     }
     abstract connection tracesToDocumentLinks : TracesToDocument[*];
@@ -129,4 +132,11 @@ package memo_artifacts_standards_traceability {
         :> annotatedElement : SysML::ConnectionUsage;
         :>> baseType = tracesToDocumentLinks meta SysML::Usage;
     }
+    // A rule's trace to the clause it enforces: `#EnforcesClause dependency from
+    // <Rule> to <clause>, <clause>;`. A rule may trace to several clauses, from
+    // several standards, or to none (a rule MEMO or a user holds for its own
+    // reasons). A SysML Dependency, so it needs no MEMO grammar and any
+    // SysML v2 tool reads it as client and supplier.
+    metadata def EnforcesClause;
 }

package/src/artifacts/templates/dhf/fda-cybersecurity/postmarket-surveillance.md CHANGED Viewed

@@ -30,8 +30,7 @@ Defines ongoing cybersecurity surveillance for **{{project.product}}** in the po
 Describe the process for ongoing monitoring of SOUP components for newly published vulnerabilities.
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc
 sort: name

package/src/artifacts/templates/dhf/fda-cybersecurity/vuln-assessment.md CHANGED Viewed

@@ -37,8 +37,7 @@ empty: "No software assets defined."
 Known vulnerabilities in SOUP and third-party components (e.g. from CVE/NVD monitoring) and their disposition:
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc
 sort: name

package/src/artifacts/templates/dhf/iec-62304/sad.md CHANGED Viewed

@@ -83,8 +83,7 @@ empty: "No Interface elements defined."
 Software of Unknown Provenance (SOUP) used by **{{project.product}}** is listed below per IEC 62304 §5.3.3–5.3.4. For each SOUP item, functional/performance requirements and required hardware/software must be specified:
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc, layer
 sort: name

package/src/artifacts/templates/dhf/iec-62304/sbom.md CHANGED Viewed

@@ -37,8 +37,7 @@ empty: "No first-party software items defined."
 All third-party and SOUP components with their versions and origins, generated from the model:
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc, layer
 sort: name

package/src/artifacts/templates/dhf/iec-62304/sdp.md CHANGED Viewed

@@ -57,8 +57,7 @@ Identify the coding standards, review procedures, and quality gates applied duri
 ### 4.1 Software Items of Unknown Provenance (SOUP)
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc, layer
 sort: name

package/src/artifacts/templates/dhf/iec-62304/soup.md CHANGED Viewed

@@ -23,12 +23,11 @@ This document lists all Software of Unknown Provenance (SOUP) components used in
 The complete inventory of SOUP and third-party components in **{{project.product}}**, generated from the model:
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, layer, doc
 sort: name
-empty: "No SOUP components defined. Add SOUPComponent elements to the model."
+empty: "No SOUP components defined. Add SOUPSoftwareModule or OTSSoftwareModule elements to the model."
 ```
 ---
@@ -38,8 +37,7 @@ empty: "No SOUP components defined. Add SOUPComponent elements to the model."
 For each SOUP component, the potential impact on device safety must be evaluated.
 ```memo-query
-kind: SoftwareModule
-where: moduleKind == "SoftwareModuleKind::soup"
+kind: [SOUPSoftwareModule, OTSSoftwareModule]
 display: table
 columns: name, doc
 sort: name

package/src/artifacts/templates/dhf/system/sad.md CHANGED Viewed

@@ -123,7 +123,7 @@ _[TODO: Describe how safety-critical items are segregated from non-safety-critic
 ## 5. SOUP Components
-Software of Unknown Provenance used by **{{project.product}}**, derived by traversing `dependsOnSoup` from the software items. MEMO has no `SOUPComponent` kind: SOUP is a *relationship* a project's own software item has to a third-party item, which is why it is traversed rather than typed.
+Software of Unknown Provenance used by **{{project.product}}**, derived by traversing `dependsOnSoup` from the software items. A SOUP item is typed `SOUPSoftwareModule` (an `OTSSoftwareModule` is one); this section lists the ones a project software item depends on.
 ```memo-query
 kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]