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Software Requirements Specification (SRS) – CardioMonitor Pro ECG-12

  • Document: Software Requirements Specification (SRS)
  • Product: CardioMonitor Pro ECG-12
  • Version: 1.1.0

  • Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025- Creation Date: November 16, 2025

  • Letzte Überarbeitung: 19. November 2025- Last Revision: November 16, 2025

  • Nächste Überprüfung: 19. November 2026- Next Review: November 16, 2026

  • Approved by: [QA / RM Responsible]
  • Responsible: [Software Project Manager]

1 Purpose

Definition of all software requirements including safety, risk, and quality requirements according to IEC 62304. Each requirement receives a unique ID (SR-###).

2 References

  • Development Plan: 30.01_software_development_plan.md
  • Architecture: 30.02_software_architecture.md
  • Risk Management File: 20.01_risk_management_file.md

3 Global Assumptions & Framework Conditions

  • Device has sufficient computing power for real-time ECG analysis.
  • Power supply stable within specified ranges.
  • Operating personnel trained (see RMF responsibilities).

4 Safety Classification (Mapping SR → Class)

SR-ID Class Justification
SR-001 C Error could falsify critical diagnosis
SR-010 B Error affects data quality, no direct harm
SR-020 A UI convenience function

5 Functional Requirements (Excerpt)

ID Title Description Source Class
SR-001 Arrhythmia Detection System shall detect cardiac arrhythmias (AFib, VT, Bradycardia) Product Goal / Risk R002 C
SR-002 Signal Quality Indicator Display quality status (Good/Medium/Poor) Risk R002 (Artifacts) B
SR-003 Data Persistence Store all analyses with timestamp Risk R004 B
SR-004 Backup Redundancy Redundant storage of local analysis results Risk R004 B
SR-005 User Warning Analysis Error UI warning for uncertain analysis results Risk R002 C
SR-006 Export ECG Data Export in standardized format Stakeholder A

6 Non-Functional Requirements

ID Category Description Measurement Criterion
SR-010 Performance Analysis < 2 seconds for 10s ECG Benchmark
SR-011 Robustness System tolerates short-term signal disturbances < 1s Test Case TC-045
SR-012 Reliability Error rate of critical modules < 1e-4/h Operating Statistics
SR-013 Security Integrity check of each analysis Code Review / Test
SR-014 Auditability Logging of safety-relevant states Log Review
ID Risk-ID Measure Description Verification
SR-001 R002 Validated Algorithms Diagnostic algorithms must be validated (Sens/Spec) System Test + Clinical Study
SR-002 R002 Quality Check Signal quality flag before analysis Unit / Integration Test
SR-003 R004 Storage Redundancy Dual storage of results Integration Test
SR-005 R002 UI Warning Notice Warning for uncertain analysis UI Test
SR-013 R001/R002 Integrity Checks Watchdog & Data Validation System Test

8 Interface Requirements

ID Interface Description Validation
SR-020 IF-02 Transfer of filtered data to analysis Integration Test
SR-021 IF-03 Transfer of analysis result to UI System Test
SR-022 IF-04 Persistence parameters Integration Test

9 Data and Persistence Requirements

  • All analysis results contain: timestamp, parameters (Heart Rate, Rhythm-Flags), quality flag, algorithm version info.
  • Integrity hash to ensure immutability.

10 Quality Attributes / Metrics

Attribute Target Measurement
Test Coverage Class C Modules ≥ 90% Branch Coverage Report
Complexity (Cyclomatic) < 15 per Class C Function Static Analysis
False Alarm Rate < 5% on validated dataset Clinical Validation

11 Verification Strategy

Level Goal Means
Unit Test Correct logic of individual functions PyTest / CTest
Integration Module interaction Simulation Data
System End-to-End ECG Analysis Test Datasets
Clinical Algorithm Validation Study Protocol

12 Change Control

New Requirements → Impact Analysis (Risk / Architecture) → ID Assignment → Inclusion in Traceability Matrix → Implementation → Verification → Release.

13 Appendices

  • A: Glossary
  • B: Test Dataset Description
  • C: Validation Criteria

Appendix D: Change History

Date Version Author Changes
19. November 2025 1.1.0 Unbekannt Automatische Metadatenaktualisierung
17. November 2025 1.0.1 Unbekannt Automatische Metadatenaktualisierung

See Also