memo_artifacts_standards_iec_81001_5_1

SysML API

Public namespace	memo::artifacts::standards
Declared package	memo_artifacts_standards_iec_81001_5_1
Source	src/artifacts/standards/iec_81001_5_1.sysml

Namespace hierarchy

memo → memo::artifacts → memo::artifacts::standards

Packages

Package
memo_artifacts_standards_iec_81001_5_1

Imports

Visibility	Target
private	ScalarValues::*
private	memo_core_enumerations::*
private	memo_core_relationships::*
private	memo_artifacts_standards_traceability::*

Declarations

Name	SysML kind	Description	Specializes
—	—	—	—

Source

artifacts/standards/iec_81001_5_1.sysml

// IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
//
// Clause instances, not type machinery. Everything here is data: adding a
// standard is one file like this one and zero TypeScript changes.
package memo_artifacts_standards_iec_81001_5_1 {
    private import ScalarValues::*;
    private import memo_core_enumerations::*;
    private import memo_core_relationships::*;
    private import memo_artifacts_standards_traceability::*;

    item iec81001_5_1 : RegulatoryStandard {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "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 {
        attribute :>> id = "STD-IEC-81001-5-1-5-8";
        attribute :>> name = "IEC81001_5_1Clause5_8";
        attribute :>> clauseNumber = "5.8";
        attribute :>> title = "software release";
        attribute :>> normativeStrength = "shall";
    }

    connection iec81001_5_1Has4 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause4;
    connection iec81001_5_1Has5 : Composes connect parent ::> iec81001_5_1 to child ::> iec81001_5_1Clause5;

    connection iec81001_5_1Has5_1 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_1;
    connection iec81001_5_1Has5_2 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_2;
    connection iec81001_5_1Has5_3 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_3;
    connection iec81001_5_1Has5_4 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_4;
    connection iec81001_5_1Has5_8 : Composes connect parent ::> iec81001_5_1Clause5 to child ::> iec81001_5_1Clause5_8;
}