@memoarchitect/ontology 0.6.5 → 0.8.22

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/incident-response.md

@@ -2,7 +2,7 @@
 id: incident-response
 title: Cybersecurity Incident Response Plan
 standard: FDA Cybersecurity Guidance 2023
-clauses: ["5.2"]
+clauses: ["VI"]
 required_for: ["FDA_510k", "FDA_PMA"]
 ---
 

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/postmarket-surveillance.md

@@ -2,7 +2,7 @@
 id: postmarket-surveillance
 title: Post-Market Cybersecurity Surveillance Plan
 standard: FDA Cybersecurity Guidance 2023
-clauses: ["5"]
+clauses: ["VI"]
 required_for: ["FDA_510k", "FDA_PMA"]
 ---
 
@@ -30,7 +30,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/security-arch.md

@@ -2,7 +2,7 @@
 id: security-arch
 title: Cybersecurity Architecture Description
 standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.3"]
+clauses: ["V.B"]
 required_for: ["FDA_510k", "FDA_PMA"]
 ---
 
@@ -45,7 +45,7 @@ empty: "No interfaces defined."
 Security controls implemented in **{{project.product}}** are listed below from the model. Each control should trace to at least one identified threat:
 
 ```memo-query
-kind: SecurityControl
+kind: RiskControlMeasure
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/threat-model.md

@@ -2,7 +2,7 @@
 id: threat-model
 title: Cybersecurity Threat Model
 standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.2"]
+clauses: ["V.A"]
 required_for: ["FDA_510k", "FDA_PMA"]
 ---
 
@@ -23,7 +23,7 @@ This threat model documents cybersecurity threats for **{{project.product}}** pe
 Assets requiring protection (data, functions, interfaces), drawn from the model:
 
 ```memo-query
-kind: [SoftwareSystem, Interface, SOUPComponent]
+kind: [SoftwareSystem, InterfaceElement, SoftwareModule]
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -51,7 +51,7 @@ empty: "No interfaces defined."
 The threat catalog below is generated from the model. Each threat should be assessed for likelihood and impact and trace to mitigating security controls:
 
 ```memo-query
-kind: ThreatModel
+kind: [FMEAWorksheet, FaultTree, HAZOPStudy]
 display: table
 columns: name, layer, doc
 sort: name
@@ -76,7 +76,7 @@ empty: "No threat model elements defined. Add ThreatModel elements."
 Security controls implemented in **{{project.product}}** are listed below from the model. Each control should trace to at least one identified threat:
 
 ```memo-query
-kind: SecurityControl
+kind: RiskControlMeasure
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/fda-cybersecurity/vuln-assessment.md

@@ -2,7 +2,7 @@
 id: vuln-assessment
 title: Vulnerability Assessment and Penetration Testing Report
 standard: FDA Cybersecurity Guidance 2023
-clauses: ["3.4"]
+clauses: ["V.C"]
 required_for: ["FDA_510k", "FDA_PMA"]
 ---
 
@@ -23,7 +23,7 @@ Documents cybersecurity vulnerability assessment and testing for **{{project.pro
 Define the boundaries of this assessment: components, interfaces, and threat classes in and out of scope.
 
 ```memo-query
-kind: [SoftwareSystem, SoftwareItem, Interface]
+kind: [HardwareComponent, HardwareAssembly, SoftwareSystem, SoftwareComponent, SoftwareModule, InterfaceElement, MemoPort]
 display: table
 columns: name, kind, layer
 sort: name
@@ -37,7 +37,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc
 sort: name

package/src/artifacts/templates/dhf/iec-60601/hrs.md

@@ -0,0 +1,170 @@
+---
+id: hrs
+title: Hardware Requirements Specification
+standard: IEC 60601-1:2005+AMD1:2012+AMD2:2020
+clauses: ["8", "9", "11", "15", "IEC 60601-1-2:2014+AMD1:2020 §7"]
+required_for: ["CE", "FDA_510k", "MDR"]
+---
+
+{{include:shared/snippets/document-control-header.md}}
+
+{{toc}}
+
+---
+
+## 1. Purpose
+
+This Hardware Requirements Specification (HRS) defines the safety, construction, and performance requirements for the **{{project.product}}** physical equipment, ensuring compliance with IEC 60601-1 (general safety) and applicable collateral standards (IEC 60601-1-2 for electromagnetic compatibility).
+
+Hardware requirements are identified by the model's `requirementKind` attribute. Per-topic sections — construction, electrical, EMC, mechanical — are **not** name filters: each is the set of elements claiming the clause that governs that topic, selected by traversing `ConformsTo` to that clause. A clause is named by its element id rather than by its number, because a clause number is not unique across standards: "8" is a clause of IEC 60601-1, of IEC 60601-1-2 and of IEC 62304.
+
+---
+
+## 2. Hardware Requirements Summary
+
+Summary metrics for the hardware requirements captured in the model:
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::hardware"
+display: count
+label: Total hardware requirements
+```
+
+### All Hardware Requirements
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::hardware"
+display: table
+columns: name, requirementKind, electricalSafetyRelevant, doc
+sort: name
+empty: "No hardware requirements defined. Add Requirement elements with requirementKind = hardware."
+```
+
+---
+
+## 3. Physical & Construction Requirements (IEC 60601-1 §15)
+
+The physical elements these requirements govern:
+
+```memo-query
+kind: [PhysicalAssembly, HardwareAssembly, PhysicalSubassembly, PhysicalComponent, HardwareComponent, PhysicalConnectorPart]
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No physical assemblies or components defined."
+```
+
+The elements claiming IEC 60601-1 §15 are a `ConformsTo` table:
+
+```memo-query
+select: relationships
+kind: conformsTo
+where: target.id == "iec60601_1Clause15"
+display: table
+columns: source, source.kind, target.clauseNumber, target.title
+sort: source
+empty: "No elements claim IEC 60601-1 §15."
+```
+
+---
+
+## 4. Electrical Safety Requirements (IEC 60601-1 §8)
+
+Protection against electric shock, isolation, and medical-grade power supplies. The electrical elements in scope:
+
+```memo-query
+kind: [ElectricalComponent, ElectronicComponent, PhysicalConnectorPart]
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No electrical or electronic components defined."
+```
+
+```memo-query
+select: relationships
+kind: conformsTo
+where: target.id == "iec60601_1Clause8"
+display: table
+columns: source, source.kind, target.clauseNumber, target.title
+sort: source
+empty: "No elements claim IEC 60601-1 §8."
+```
+
+---
+
+## 5. Electromagnetic Compatibility (IEC 60601-1-2 §7)
+
+Immunity from electromagnetic disturbances and limits on emissions.
+
+This section is the one that pays for clause-level traceability: once a requirement carries `ConformsTo → IEC 60601-1-2 §7`, "EMC Requirements" stops being a filter over names and becomes *the set of requirements claiming that clause*. The section heading and the standard then come from one source.
+
+```memo-query
+select: relationships
+kind: conformsTo
+where: target.id == "iec60601_1_2Clause7"
+display: table
+columns: source, source.kind, target.clauseNumber, target.title
+sort: source
+empty: "No elements claim IEC 60601-1-2 §7."
+```
+
+---
+
+## 6. Mechanical, Thermal, and Environmental Requirements (IEC 60601-1 §9, §11)
+
+Mechanical strength and impact resistance (§9), excessive temperatures and ingress (§11). The elements in scope:
+
+```memo-query
+kind: [ThermalComponent, AcousticComponent, FluidicComponent, PneumaticComponent, OpticalComponent]
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No mechanical, thermal, fluidic or optical components defined."
+```
+
+```memo-query
+select: relationships
+kind: conformsTo
+where: target.id == "iec60601_1Clause9"
+display: table
+columns: source, source.kind, target.clauseNumber, target.title
+sort: source
+empty: "No elements claim IEC 60601-1 §9."
+```
+
+---
+
+## 7. Hardware Traceability
+
+Hardware requirements traced to the elements that satisfy them:
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::hardware"
+traverse: outgoing satisfiedBy
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No hardware requirements are linked to a satisfying element. Add SatisfiedBy links."
+```
+
+The allocation table proper — *which* element allocates to *which* — is relationship-shaped. It is not filtered to hardware: `AllocatedTo` joins two architecture elements and carries no layer of its own, so the receiving element's kind and layer are shown as columns instead of guessed at by a filter.
+
+```memo-query
+select: relationships
+kind: allocatedTo
+display: table
+columns: source, target, target.kind, target.layer
+sort: target
+empty: "No allocations defined."
+```
+
+---
+
+{{include:shared/snippets/revision-history-table.md}}
+
+{{include:shared/snippets/approval-block.md}}
+
+{{include:shared/snippets/references-section.md}}

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/detailed-design.md

@@ -23,7 +23,7 @@ This document provides detailed design specifications for **{{project.product}}*
 The software units — the lowest level of decomposition per IEC 62304 — are listed below from the model:
 
 ```memo-query
-kind: SoftwareUnit
+kind: SoftwareModule
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/integration-test.md

@@ -23,7 +23,7 @@ This Integration Test Plan defines the approach for integration testing of **{{p
 The software items in scope for this test plan, drawn from the model:
 
 ```memo-query
-kind: [SoftwareItem, SoftwareUnit]
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -37,8 +37,8 @@ empty: "No software items defined."
 Integration test cases are listed below from the model:
 
 ```memo-query
-kind: TestCase
-where: layer == "verification"
+kind: VerificationCase
+where: layer == "verification_validation"
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sad.md

@@ -33,7 +33,7 @@ empty: "No SoftwareSystem defined."
 **Total elements:**
 
 ```memo-query
-kind: [SoftwareSystem, SoftwareItem, SoftwareUnit, SOUPComponent]
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: count
 label: Total software elements
 ```
@@ -49,17 +49,17 @@ This section describes the decomposition of the software into software items per
 ### 3.1 Software Items
 
 ```memo-query
-kind: SoftwareItem
+kind: [HardwareComponent, HardwareAssembly, SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, layer, doc
 sort: name
-empty: "No SoftwareItem elements defined."
+empty: "No SoftwareElement elements defined."
 ```
 
 ### 3.2 Software Units
 
 ```memo-query
-kind: SoftwareUnit
+kind: SoftwareModule
 display: table
 columns: name, layer, doc
 sort: name
@@ -83,7 +83,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc, layer
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sbom.md

@@ -23,7 +23,7 @@ This Software Bill of Materials (SBOM) provides a complete inventory of software
 Software developed in-house for this system is listed below from the model:
 
 ```memo-query
-kind: [SoftwareSystem, SoftwareItem, SoftwareUnit]
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -37,7 +37,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc, layer
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sdp.md

@@ -27,11 +27,11 @@ This Software Development Plan (SDP) defines the processes, activities, and task
 | {{project.product}} Software System | Class B | |
 
 ```memo-query
-kind: [SoftwareSystem, SoftwareItem]
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, kind, layer, doc
 sort: name
-empty: "No software items defined. Add SoftwareSystem or SoftwareItem elements."
+empty: "No structural software elements defined. Add SoftwareSystem or SoftwareElement elements."
 ```
 
 ---
@@ -57,7 +57,8 @@ Identify the coding standards, review procedures, and quality gates applied duri
 ### 4.1 Software Items of Unknown Provenance (SOUP)
 
 ```memo-query
-kind: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc, layer
 sort: name
@@ -68,7 +69,7 @@ empty: "No SOUP components defined."
 
 ```memo-query
 kind: Hazard
-where: layer == "software"
+where: layer == "implementation"
 display: table
 columns: name, doc, layer
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/soup.md

@@ -23,7 +23,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, layer, doc
 sort: name
@@ -37,7 +38,8 @@ 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: SOUPComponent
+kind: SoftwareModule
+where: moduleKind == "SoftwareModuleKind::soup"
 display: table
 columns: name, doc
 sort: name

package/src/artifacts/templates/dhf/iec-62304/srs.md

@@ -0,0 +1,172 @@
+---
+id: srs
+title: Software Requirements Specification
+standard: IEC 62304:2006+AMD1:2015
+clauses: ["5.2", "5.2.2", "5.2.3", "5.2.6"]
+required_for: ["CE", "FDA_510k", "MDR"]
+---
+
+{{include:shared/snippets/document-control-header.md}}
+
+{{toc}}
+
+---
+
+## 1. Purpose
+
+This Software Requirements Specification (SRS) defines the software requirements for **{{project.product}}** in accordance with IEC 62304:2006+AMD1:2015 §5.2.
+
+Software, hardware and system requirements are distinguished by the model's own `requirementKind` attribute, never by which layer directory a file sits in and never by what a requirement is called. There is no "software layer": hardware and software are sibling directories inside `implementation`.
+
+---
+
+## 2. Requirements Summary
+
+Summary metrics for the requirements captured in the model:
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::software"
+display: count
+label: Total software requirements
+```
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::system"
+display: count
+label: System requirements
+```
+
+---
+
+## 3. Functional Requirements
+
+Requirements carrying a `shall` obligation — the binding ones:
+
+```memo-query
+kind: Requirement
+where: obligation == "ObligationKind::shall"
+display: table
+columns: name, requirementKind, safetyClass, doc
+sort: name
+empty: "No requirements carry a `shall` obligation. Set `obligation` on Requirement elements."
+```
+
+### All Software Requirements
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::software"
+display: table
+columns: name, requirementKind, safetyClass, doc
+sort: name
+empty: "No software requirements defined. Add Requirement elements with requirementKind = software."
+```
+
+---
+
+## 3.1 Hardware-Software Interface Requirements
+
+The hardware/software boundary is a modelled element, not a naming convention. The interfaces and ports below are the boundary this software crosses; requirements are traced to them through the model rather than selected by having "interface" in their name.
+
+```memo-query
+kind: [InterfaceElement, MemoPort]
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No interfaces or ports defined."
+```
+
+Requirements satisfied by elements on that boundary:
+
+```memo-query
+kind: [InterfaceElement, MemoPort]
+traverse: incoming satisfiedBy
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No software requirements are linked to a satisfying architecture element. Add SatisfiedBy links."
+```
+
+---
+
+## 4. System Requirements (Allocated to Software)
+
+System requirements allocated to software per IEC 62304 §5.2, drawn from the model:
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::system"
+display: table
+columns: name, requirementKind, safetyClass, doc
+sort: name
+empty: "No system requirements defined."
+```
+
+---
+
+## 5. Non-Functional Requirements
+
+### 5.1 Performance Requirements
+
+_[TODO: Define performance requirements (response time, throughput, memory)]_
+
+### 5.2 Safety Requirements
+
+Software safety requirements are those whose `safetyClass` is set. The hazards they derive from:
+
+```memo-query
+kind: Hazard
+display: table
+columns: name, layer, doc
+sort: name
+empty: "No hazards defined in the risk model."
+```
+
+### 5.3 Security Requirements
+
+```memo-query
+kind: SecurityRequirement
+display: table
+columns: name, layer, doc
+sort: name
+empty: "No security requirements defined."
+```
+
+---
+
+## 6. SOUP Requirements
+
+Software of Unknown Provenance depended on by **{{project.product}}**, derived by traversing `dependsOnSoup` from the software items:
+
+```memo-query
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
+traverse: outgoing dependsOnSoup
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No SOUP identified. Add DependsOnSoup links from software items to the SOUP they depend on."
+```
+
+---
+
+## 7. Requirements Traceability
+
+```memo-query
+kind: Requirement
+where: requirementKind == "RequirementKind::software"
+traverse: outgoing verifiedBy
+display: table
+columns: name, kind, layer, doc
+sort: name
+empty: "No software requirements are linked to a verification case. Add VerifiedBy links."
+```
+
+---
+
+{{include:shared/snippets/revision-history-table.md}}
+
+{{include:shared/snippets/approval-block.md}}
+
+{{include:shared/snippets/references-section.md}}

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/sw-traceability.md

@@ -35,7 +35,7 @@ label: Software requirements
 ```
 
 ```memo-query
-kind: TestCase
+kind: VerificationCase
 display: count
 label: Test cases
 ```
@@ -75,7 +75,7 @@ empty: "No software requirements defined."
 This section is generated from the system model. The table below lists the **Software Requirements → Design Elements** elements currently defined:
 
 ```memo-query
-kind: [SoftwareItem, SoftwareUnit]
+kind: [SoftwareSystem, SoftwareComponent, SoftwareModule]
 display: table
 columns: name, kind, layer, doc
 sort: name
@@ -89,7 +89,7 @@ empty: "No software design elements defined."
 This section is generated from the system model. The table below lists the **Test Cases** elements currently defined:
 
 ```memo-query
-kind: TestCase
+kind: VerificationCase
 display: table
 columns: name, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62304/system-test.md

@@ -37,7 +37,7 @@ empty: "No system requirements defined."
 This section is generated from the system model. The table below lists the **System Test Cases** elements currently defined:
 
 ```memo-query
-kind: [TestCase, ValidationActivity]
+kind: [VerificationCase, ValidationCase]
 display: table
 columns: name, kind, layer, doc
 sort: name

package/src/{compliance/dhf-templates → artifacts/templates/dhf}/iec-62366/summative-eval.md

@@ -31,7 +31,7 @@ _[TODO: Describe participant demographics, number, and selection criteria]_
 This section is generated from the system model. The table below lists the **Test Scenarios** elements currently defined:
 
 ```memo-query
-kind: [UseCase, ValidationActivity]
+kind: [UseCase, ValidationCase]
 display: table
 columns: name, layer, doc
 sort: name