memo_artifacts_standards_iec_62304
SysML API
Namespace hierarchy
memo → memo::artifacts → memo::artifacts::standards
Packages
| Package |
memo_artifacts_standards_iec_62304 |
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_62304.sysml
package memo_artifacts_standards_iec_62304 {
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 iec62304 : RegulatoryStandard {
@MemoIdentity { :>> providedId = "STD-IEC-62304"; }
attribute :>> designation = "IEC 62304:2006+AMD1:2015";
attribute :>> edition = "2006";
attribute :>> issuer = "IEC";
attribute :>> amendments = "AMD1:2015";
attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA, RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
part iec62304Clause4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-4"; }
attribute :>> clauseNumber = "4";
attribute :>> title = "general lifecycle prerequisites";
attribute :>> normativeStrength = "shall";
part iec62304Clause4_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-4-1"; }
attribute :>> clauseNumber = "4.1";
attribute :>> title = "quality management system";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause4_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-4-2"; }
attribute :>> clauseNumber = "4.2";
attribute :>> title = "risk management activities";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause4_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-4-3"; }
attribute :>> clauseNumber = "4.3";
attribute :>> title = "software safety classification";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause4_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-4-4"; }
attribute :>> clauseNumber = "4.4";
attribute :>> title = "legacy software";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5"; }
attribute :>> clauseNumber = "5";
attribute :>> title = "software development process";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1"; }
attribute :>> clauseNumber = "5.1";
attribute :>> title = "software development planning";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_1_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-1"; }
attribute :>> clauseNumber = "5.1.1";
attribute :>> title = "software development plan";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-2"; }
attribute :>> clauseNumber = "5.1.2";
attribute :>> title = "keeping the development plan current";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-3"; }
attribute :>> clauseNumber = "5.1.3";
attribute :>> title = "plan reference to system design and development";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-4"; }
attribute :>> clauseNumber = "5.1.4";
attribute :>> title = "development standards, methods and tools planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-5"; }
attribute :>> clauseNumber = "5.1.5";
attribute :>> title = "integration and integration test planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-6"; }
attribute :>> clauseNumber = "5.1.6";
attribute :>> title = "verification planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-7"; }
attribute :>> clauseNumber = "5.1.7";
attribute :>> title = "software risk management planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-8"; }
attribute :>> clauseNumber = "5.1.8";
attribute :>> title = "documentation planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_9 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-9"; }
attribute :>> clauseNumber = "5.1.9";
attribute :>> title = "configuration management planning";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_10 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-10"; }
attribute :>> clauseNumber = "5.1.10";
attribute :>> title = "supporting items to be controlled";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_11 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-11"; }
attribute :>> clauseNumber = "5.1.11";
attribute :>> title = "configuration item control before verification";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_1_12 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-1-12"; }
attribute :>> clauseNumber = "5.1.12";
attribute :>> title = "identifying and avoiding common software defects";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2"; }
attribute :>> clauseNumber = "5.2";
attribute :>> title = "software requirements analysis";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_2_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-1"; }
attribute :>> clauseNumber = "5.2.1";
attribute :>> title = "deriving software requirements from system requirements";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_2_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-2"; }
attribute :>> clauseNumber = "5.2.2";
attribute :>> title = "software requirements content";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_2_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-3"; }
attribute :>> clauseNumber = "5.2.3";
attribute :>> title = "risk control measures carried into software requirements";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_2_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-4"; }
attribute :>> clauseNumber = "5.2.4";
attribute :>> title = "re-evaluating the risk analysis";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_2_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-5"; }
attribute :>> clauseNumber = "5.2.5";
attribute :>> title = "updating requirements";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_2_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-2-6"; }
attribute :>> clauseNumber = "5.2.6";
attribute :>> title = "software requirements verification";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3"; }
attribute :>> clauseNumber = "5.3";
attribute :>> title = "software architectural design";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_3_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-1"; }
attribute :>> clauseNumber = "5.3.1";
attribute :>> title = "transforming requirements into an architecture";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_3_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-2"; }
attribute :>> clauseNumber = "5.3.2";
attribute :>> title = "architecture for the interfaces of software items";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_3_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-3"; }
attribute :>> clauseNumber = "5.3.3";
attribute :>> title = "functional and performance requirements of SOUP items";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_3_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-4"; }
attribute :>> clauseNumber = "5.3.4";
attribute :>> title = "hardware and software required by SOUP items";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_3_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-5"; }
attribute :>> clauseNumber = "5.3.5";
attribute :>> title = "segregation needed for risk control";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_3_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-3-6"; }
attribute :>> clauseNumber = "5.3.6";
attribute :>> title = "architecture verification";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-4"; }
attribute :>> clauseNumber = "5.4";
attribute :>> title = "software detailed design";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_4_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-4-1"; }
attribute :>> clauseNumber = "5.4.1";
attribute :>> title = "subdividing software into units";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_4_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-4-2"; }
attribute :>> clauseNumber = "5.4.2";
attribute :>> title = "detailed design of each unit";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_4_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-4-3"; }
attribute :>> clauseNumber = "5.4.3";
attribute :>> title = "detailed design of interfaces";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_4_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-4-4"; }
attribute :>> clauseNumber = "5.4.4";
attribute :>> title = "detailed design verification";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5"; }
attribute :>> clauseNumber = "5.5";
attribute :>> title = "software unit implementation and verification";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_5_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5-1"; }
attribute :>> clauseNumber = "5.5.1";
attribute :>> title = "implementing each unit";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_5_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5-2"; }
attribute :>> clauseNumber = "5.5.2";
attribute :>> title = "unit verification process";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_5_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5-3"; }
attribute :>> clauseNumber = "5.5.3";
attribute :>> title = "unit acceptance criteria";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_5_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5-4"; }
attribute :>> clauseNumber = "5.5.4";
attribute :>> title = "additional unit acceptance criteria";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_5_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-5-5"; }
attribute :>> clauseNumber = "5.5.5";
attribute :>> title = "unit verification";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6"; }
attribute :>> clauseNumber = "5.6";
attribute :>> title = "software integration and integration testing";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_6_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-1"; }
attribute :>> clauseNumber = "5.6.1";
attribute :>> title = "integrating units";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-2"; }
attribute :>> clauseNumber = "5.6.2";
attribute :>> title = "verifying integration";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-3"; }
attribute :>> clauseNumber = "5.6.3";
attribute :>> title = "integration testing";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-4"; }
attribute :>> clauseNumber = "5.6.4";
attribute :>> title = "integration testing content";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-5"; }
attribute :>> clauseNumber = "5.6.5";
attribute :>> title = "evaluating integration test procedures";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-6"; }
attribute :>> clauseNumber = "5.6.6";
attribute :>> title = "regression testing";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-7"; }
attribute :>> clauseNumber = "5.6.7";
attribute :>> title = "integration test record contents";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_6_8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-6-8"; }
attribute :>> clauseNumber = "5.6.8";
attribute :>> title = "using the problem resolution process during integration";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7"; }
attribute :>> clauseNumber = "5.7";
attribute :>> title = "software system testing";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_7_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7-1"; }
attribute :>> clauseNumber = "5.7.1";
attribute :>> title = "establishing tests for software requirements";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_7_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7-2"; }
attribute :>> clauseNumber = "5.7.2";
attribute :>> title = "using the problem resolution process during system testing";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_7_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7-3"; }
attribute :>> clauseNumber = "5.7.3";
attribute :>> title = "retesting after changes";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_7_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7-4"; }
attribute :>> clauseNumber = "5.7.4";
attribute :>> title = "evaluating software system testing";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_7_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-7-5"; }
attribute :>> clauseNumber = "5.7.5";
attribute :>> title = "software system test records";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause5_8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8"; }
attribute :>> clauseNumber = "5.8";
attribute :>> title = "software release";
attribute :>> normativeStrength = "shall";
part iec62304Clause5_8_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-1"; }
attribute :>> clauseNumber = "5.8.1";
attribute :>> title = "ensuring software verification is complete";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-2"; }
attribute :>> clauseNumber = "5.8.2";
attribute :>> title = "documenting known residual anomalies";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-3"; }
attribute :>> clauseNumber = "5.8.3";
attribute :>> title = "evaluating known residual anomalies";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-4"; }
attribute :>> clauseNumber = "5.8.4";
attribute :>> title = "documenting released versions";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-5"; }
attribute :>> clauseNumber = "5.8.5";
attribute :>> title = "documenting how released software was created";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-6"; }
attribute :>> clauseNumber = "5.8.6";
attribute :>> title = "ensuring activities and tasks are complete";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-7"; }
attribute :>> clauseNumber = "5.8.7";
attribute :>> title = "archiving software";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause5_8_8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-5-8-8"; }
attribute :>> clauseNumber = "5.8.8";
attribute :>> title = "assuring reliable delivery of released software";
attribute :>> normativeStrength = "shall";
}
}
}
part iec62304Clause6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6"; }
attribute :>> clauseNumber = "6";
attribute :>> title = "software maintenance process";
attribute :>> normativeStrength = "shall";
part iec62304Clause6_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-1"; }
attribute :>> clauseNumber = "6.1";
attribute :>> title = "establishing a software maintenance plan";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2"; }
attribute :>> clauseNumber = "6.2";
attribute :>> title = "problem and modification analysis";
attribute :>> normativeStrength = "shall";
part iec62304Clause6_2_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-1"; }
attribute :>> clauseNumber = "6.2.1";
attribute :>> title = "feedback";
attribute :>> normativeStrength = "shall";
part iec62304Clause6_2_1_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-1-1"; }
attribute :>> clauseNumber = "6.2.1.1";
attribute :>> title = "monitoring feedback";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2_1_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-1-2"; }
attribute :>> clauseNumber = "6.2.1.2";
attribute :>> title = "documenting and evaluating feedback";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2_1_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-1-3"; }
attribute :>> clauseNumber = "6.2.1.3";
attribute :>> title = "evaluating the safety effect of problem reports";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause6_2_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-2"; }
attribute :>> clauseNumber = "6.2.2";
attribute :>> title = "using the problem resolution process during maintenance";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-3"; }
attribute :>> clauseNumber = "6.2.3";
attribute :>> title = "analysing change requests";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-4"; }
attribute :>> clauseNumber = "6.2.4";
attribute :>> title = "change request approval";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_2_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-2-5"; }
attribute :>> clauseNumber = "6.2.5";
attribute :>> title = "communicating to users and regulators";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause6_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-3"; }
attribute :>> clauseNumber = "6.3";
attribute :>> title = "modification implementation";
attribute :>> normativeStrength = "shall";
part iec62304Clause6_3_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-3-1"; }
attribute :>> clauseNumber = "6.3.1";
attribute :>> title = "using an established process to implement modifications";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause6_3_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-6-3-2"; }
attribute :>> clauseNumber = "6.3.2";
attribute :>> title = "re-releasing the modified software system";
attribute :>> normativeStrength = "shall";
}
}
}
part iec62304Clause7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7"; }
attribute :>> clauseNumber = "7";
attribute :>> title = "software risk management process";
attribute :>> normativeStrength = "shall";
part iec62304Clause7_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-1"; }
attribute :>> clauseNumber = "7.1";
attribute :>> title = "analysis of software contributing to hazardous situations";
attribute :>> normativeStrength = "shall";
part iec62304Clause7_1_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-1-1"; }
attribute :>> clauseNumber = "7.1.1";
attribute :>> title = "identifying software items that could contribute to a hazardous situation";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_1_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-1-2"; }
attribute :>> clauseNumber = "7.1.2";
attribute :>> title = "identifying potential causes of such a contribution";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_1_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-1-3"; }
attribute :>> clauseNumber = "7.1.3";
attribute :>> title = "evaluating published SOUP anomaly lists";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_1_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-1-4"; }
attribute :>> clauseNumber = "7.1.4";
attribute :>> title = "documenting potential causes";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause7_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-2"; }
attribute :>> clauseNumber = "7.2";
attribute :>> title = "risk control measures";
attribute :>> normativeStrength = "shall";
part iec62304Clause7_2_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-2-1"; }
attribute :>> clauseNumber = "7.2.1";
attribute :>> title = "defining risk control measures";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_2_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-2-2"; }
attribute :>> clauseNumber = "7.2.2";
attribute :>> title = "risk control measures implemented in software";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause7_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-3"; }
attribute :>> clauseNumber = "7.3";
attribute :>> title = "verification of risk control measures";
attribute :>> normativeStrength = "shall";
part iec62304Clause7_3_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-3-1"; }
attribute :>> clauseNumber = "7.3.1";
attribute :>> title = "verifying risk control measures";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_3_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-3-3"; }
attribute :>> clauseNumber = "7.3.3";
attribute :>> title = "documenting traceability";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause7_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-4"; }
attribute :>> clauseNumber = "7.4";
attribute :>> title = "risk management of software changes";
attribute :>> normativeStrength = "shall";
part iec62304Clause7_4_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-4-1"; }
attribute :>> clauseNumber = "7.4.1";
attribute :>> title = "analysing software changes with respect to safety";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_4_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-4-2"; }
attribute :>> clauseNumber = "7.4.2";
attribute :>> title = "analysing the impact of software changes on existing risk control measures";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause7_4_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-7-4-3"; }
attribute :>> clauseNumber = "7.4.3";
attribute :>> title = "performing risk management activities from the analyses";
attribute :>> normativeStrength = "shall";
}
}
}
part iec62304Clause8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8"; }
attribute :>> clauseNumber = "8";
attribute :>> title = "software configuration management process";
attribute :>> normativeStrength = "shall";
part iec62304Clause8_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-1"; }
attribute :>> clauseNumber = "8.1";
attribute :>> title = "configuration identification";
attribute :>> normativeStrength = "shall";
part iec62304Clause8_1_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-1-1"; }
attribute :>> clauseNumber = "8.1.1";
attribute :>> title = "means to identify configuration items";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause8_1_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-1-2"; }
attribute :>> clauseNumber = "8.1.2";
attribute :>> title = "SOUP identification";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause8_1_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-1-3"; }
attribute :>> clauseNumber = "8.1.3";
attribute :>> title = "identifying system configuration documentation";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause8_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-2"; }
attribute :>> clauseNumber = "8.2";
attribute :>> title = "change control";
attribute :>> normativeStrength = "shall";
part iec62304Clause8_2_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-2-1"; }
attribute :>> clauseNumber = "8.2.1";
attribute :>> title = "approving change requests";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause8_2_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-2-2"; }
attribute :>> clauseNumber = "8.2.2";
attribute :>> title = "implementing changes";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause8_2_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-2-3"; }
attribute :>> clauseNumber = "8.2.3";
attribute :>> title = "verifying changes";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause8_2_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-2-4"; }
attribute :>> clauseNumber = "8.2.4";
attribute :>> title = "traceability of changes";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause8_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-8-3"; }
attribute :>> clauseNumber = "8.3";
attribute :>> title = "configuration status accounting";
attribute :>> normativeStrength = "shall";
}
}
part iec62304Clause9 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9"; }
attribute :>> clauseNumber = "9";
attribute :>> title = "software problem resolution process";
attribute :>> normativeStrength = "shall";
part iec62304Clause9_1 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-1"; }
attribute :>> clauseNumber = "9.1";
attribute :>> title = "preparing problem reports";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_2 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-2"; }
attribute :>> clauseNumber = "9.2";
attribute :>> title = "investigating the problem";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_3 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-3"; }
attribute :>> clauseNumber = "9.3";
attribute :>> title = "advising relevant parties";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_4 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-4"; }
attribute :>> clauseNumber = "9.4";
attribute :>> title = "using the change control process";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_5 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-5"; }
attribute :>> clauseNumber = "9.5";
attribute :>> title = "maintaining records";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_6 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-6"; }
attribute :>> clauseNumber = "9.6";
attribute :>> title = "analysing problems for trends";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_7 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-7"; }
attribute :>> clauseNumber = "9.7";
attribute :>> title = "verifying problem resolution";
attribute :>> normativeStrength = "shall";
}
part iec62304Clause9_8 : StandardClause {
@MemoIdentity { :>> providedId = "STD-IEC-62304-9-8"; }
attribute :>> clauseNumber = "9.8";
attribute :>> title = "test documentation contents";
attribute :>> normativeStrength = "shall";
}
}
}
}