memo_assurance_requirements

SysML API

Public namespace	memo::assurance::requirements
Declared package	memo_assurance_requirements
Source	src/assurance/requirements/memo_requirements.sysml

Namespace hierarchy

memo → memo::assurance → memo::assurance::requirements

Packages

Package
memo_assurance_requirements

Imports

Visibility	Target
private	ScalarValues::*
private	memo_core_common::*
private	memo_core_enumerations::*
private	memo_assurance_requirements_needs::*

Declarations

Name	SysML kind	Description	Specializes
RiskDriver	part def	Risk driver definition specializing RequirementDriver.	RequirementDriver
RequirementTypeKind	enum def	What a requirement is about: the system, the software, the hardware, or the instructions for use. One axis, and the members are its values. It carried a second axis until now.…	—
Requirement	requirement def	Requirement definition specializing MemoRequirement.	MemoRequirement
SystemConstant	part def	Named constant defined by a source requirements document (e.g. CriSys GPCA App. A.4) and referenced from requirement statements.	MemoPart
NotificationSpec	part def	One row of a notification/alarm action table (e.g. CriSys GPCA REQ 59): a named notification, its priority, and the actions the system must take.	MemoPart

RiskDriver

part def RiskDriver specializes RequirementDriver

Property	Value
Description	Risk driver definition specializing RequirementDriver.
Kind	part def
Abstract	No
Specializes	RequirementDriver
Owning package	memo_assurance_requirements

RequirementTypeKind

enum def RequirementTypeKind

Property	Value
Description	What a requirement is about: the system, the software, the hardware, or the instructions for use. One axis, and the members are its values. It carried a second axis until now.…
Kind	enum def
Abstract	No
Specializes	—
Owning package	memo_assurance_requirements

Requirement

requirement def Requirement specializes MemoRequirement

Property	Value
Description	Requirement definition specializing MemoRequirement.
Kind	requirement def
Abstract	No
Specializes	MemoRequirement
Owning package	memo_assurance_requirements

SystemConstant

part def SystemConstant specializes MemoPart

Property	Value
Description	Named constant defined by a source requirements document (e.g. CriSys GPCA App. A.4) and referenced from requirement statements.
Kind	part def
Abstract	No
Specializes	MemoPart
Owning package	memo_assurance_requirements

NotificationSpec

part def NotificationSpec specializes MemoPart

Property	Value
Description	One row of a notification/alarm action table (e.g. CriSys GPCA REQ 59): a named notification, its priority, and the actions the system must take.
Kind	part def
Abstract	No
Specializes	MemoPart
Owning package	memo_assurance_requirements

Source

assurance/requirements/memo_requirements.sysml

package memo_assurance_requirements {
    private import ScalarValues::*;

    private import memo_core_common::*;
    private import memo_core_enumerations::*;
    // StakeholderNeed and the needs hierarchy now live in memo_assurance_requirements_needs.
    private import memo_assurance_requirements_needs::*;
    part def RiskDriver specializes RequirementDriver { attribute driverKind : String; }

    // What a requirement is about: the system, the software, the hardware, or
    // the instructions for use. One axis, and the members are its values.
    //
    // It carried a second axis until now. `systemSpecification`,
    // `softwareSpecification`, `hardwareSpecification` and `designControl` are
    // the design-control ROLE — input versus output, 21 CFR 820.30(c)/(d) and
    // ISO 13485 §7.3.3/§7.3.4 — multiplied into the subject. A requirement then
    // could not say "software" without also committing to a role, the grid was
    // incomplete by construction (there is no `ifuSpecification`, and there
    // would have to be one for every future pairing), and nothing ever used the
    // four: 250 requirements across the examples say system, software or
    // hardware. A role, if a project needs one, is its own attribute.
    //
    // The instructions for use are neither hardware nor software: the device
    // satisfies such a requirement with words rather than with a part or a
    // module, and it is verified by reviewing the IFU rather than by testing a
    // build (EU MDR Annex I §23.4, ISO 20417, IEC 62366-1 §7.2).
    enum def RequirementTypeKind {
        enum system;
        enum software;
        enum hardware;
        enum ifu;
    }

    requirement def Requirement specializes MemoRequirement {
        attribute requirementType : RequirementTypeKind;
        attribute :>> statement : String;
        attribute sourceKind : RequirementSourceKind;
        attribute concernKind : ConcernKind;
        // Editorial state is the inherited `status : ElementStatusKind` — the
        // one status vocabulary in MEMO. Whether a requirement is implemented,
        // verified, or validated is read from its Realizes / VerifiedBy /
        // Validates links, not restated here.
        attribute :>> acceptanceCriteria : String;
        attribute subjectDescription : String;
        attribute actorDescription : String;
        attribute assumptionSummary : String;
        attribute guaranteeSummary : String;
        // Authoring notation. `notation` selects the syntactic discipline the
        // `statement` follows; the slot attributes below carry the parsed clauses
        // so tools can lint pattern conformance and render either style.
        attribute notation : RequirementNotationKind;
        attribute earsPattern : EarsPatternKind;   // applies when notation = ears
        attribute obligation : ObligationKind;      // shall/should/will (RFC 2119, SOPHIST legal-obligation)
        attribute conditionClause : String;         // EARS When/While/If/Where or SOPHIST condition clause
        attribute systemResponse : String;          // the "shall <system response>" predicate
        // software requirement / specification (IEC 62304)
        attribute safetyClass : SafetyClassKind[0..1];
        // hardware requirement
        attribute electricalSafetyRelevant : Boolean;
        // design-control specification (ISO 13485 design output)
        attribute specificationDomain : String;
        attribute sourceFolder : String;
    }
    // Named constant defined by a source requirements document (e.g. CriSys
    // GPCA App. A.4) and referenced from requirement statements.
    part def SystemConstant specializes MemoPart {
        attribute symbol : String;          // identifier as written in the source, e.g. "Tolerance_Max const"
        attribute unit : String;
        attribute valueType : String;
        attribute constantValue : String;   // empty when the source leaves the value open
        attribute valueCondition : String;  // constraints on the value stated by the source
    }
    // One row of a notification/alarm action table (e.g. CriSys GPCA REQ 59):
    // a named notification, its priority, and the actions the system must take.
    part def NotificationSpec specializes MemoPart {
        attribute priority : NotificationPriorityKind;
        attribute visualNotification : Boolean;
        attribute audioNotification : Boolean;
        attribute inhibitInfusion : Boolean;
        attribute inhibitSquareBolus : Boolean;
        attribute inhibitPatientBolus : Boolean;
        attribute stopBolus : Boolean;
    }
}