memo_artifacts_standards_iec_62366_1

SysML API

Public namespace	memo::artifacts::standards
Declared package	memo_artifacts_standards_iec_62366_1
Source	src/artifacts/standards/iec_62366_1.sysml

Namespace hierarchy

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

Packages

Package
memo_artifacts_standards_iec_62366_1

Imports

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

Declarations

Name	SysML kind	Description	Specializes
—	—	—	—

Source

artifacts/standards/iec_62366_1.sysml

// IEC 62366-1:2015+AMD1:2020 — application of usability engineering to
// medical devices.
//
// The amendment is carried in the designation: dropping it is a CE/MDR
// regression. `title` is a MEMO-AUTHORED scope phrase, never the standard's
// own normative wording.
package memo_artifacts_standards_iec_62366_1 {
    private import ScalarValues::*;
    private import memo_core_enumerations::*;
    private import memo_core_relationships::*;
    private import memo_artifacts_standards_traceability::*;

    private import memo_core_common::*;
    private import memo_core_common::MemoIdentity;
    part iec62366_1 : RegulatoryStandard {
        @MemoIdentity { :>> providedId = "STD-IEC-62366-1"; }
        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);
        part iec62366_1Clause4 : StandardClause {
            @MemoIdentity { :>> providedId = "STD-IEC-62366-1-4"; }
            attribute :>> clauseNumber = "4";
            attribute :>> title = "general requirements for the usability engineering process";
            attribute :>> normativeStrength = "shall";
        }
        part iec62366_1Clause5 : StandardClause {
            @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5"; }
            attribute :>> clauseNumber = "5";
            attribute :>> title = "usability engineering process";
            attribute :>> normativeStrength = "shall";
            part iec62366_1Clause5_1 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-1"; }
                attribute :>> clauseNumber = "5.1";
                attribute :>> title = "use specification";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_2 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-2"; }
                attribute :>> clauseNumber = "5.2";
                attribute :>> title = "user interface characteristics related to safety";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_3 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-3"; }
                attribute :>> clauseNumber = "5.3";
                attribute :>> title = "known and foreseeable use-related hazards";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_4 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-4"; }
                attribute :>> clauseNumber = "5.4";
                attribute :>> title = "hazard-related use scenarios";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_5 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-5"; }
                attribute :>> clauseNumber = "5.5";
                attribute :>> title = "selection of use scenarios for summative evaluation";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_6 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-6"; }
                attribute :>> clauseNumber = "5.6";
                attribute :>> title = "user interface specification";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_7 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-7"; }
                attribute :>> clauseNumber = "5.7";
                attribute :>> title = "user interface evaluation plan";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_8 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-8"; }
                attribute :>> clauseNumber = "5.8";
                attribute :>> title = "user interface design and formative evaluation";
                attribute :>> normativeStrength = "shall";
            }
            part iec62366_1Clause5_9 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-IEC-62366-1-5-9"; }
                attribute :>> clauseNumber = "5.9";
                attribute :>> title = "summative evaluation of the user interface";
                attribute :>> normativeStrength = "shall";
            }
        }
    }



}