Skip to content

Software Architecture (IEC 62304) – CardioMonitor Pro ECG-12

  • Document: Software Architecture
  • 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: 16 November 2025

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

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

  • Approved By: [Software Project Manager]
  • Responsible: [Software Architect]

1 Purpose

Presentation of the structural decomposition, interfaces, and safety classification of the software according to IEC 62304.

2 Overview (Context Diagram – Textual)

Level Components Description
System Device hardware, software stack Overall ECG device system
Software Firmware, embedded app, analysis module, UI module Software layers
External PC / Cloud, user, accessories Interactions

3 Safety Classification (Reiteration / Detailing)

Software Item Description Class Justification
SI-ANALYSIS ECG analysis algorithm C Impact on diagnosis/alarm
SI-SIGNAL Signal preprocessing (filter, normalization) B Error could reduce data quality
SI-UI Display, settings A No direct impact on patient safety
SI-DATA Storage / transmission B Data loss can cause delay
SI-SEC Security/integrity checks C Protection against hazardous error states

4 Architecture Layers

  1. Hardware Abstraction (drivers, sensor access)
  2. Signal Preprocessing (filtering, noise suppression)
  3. Analysis / Diagnosis (arrhythmia detection, parameter calculation)
  4. Safety & Integrity Control (watchdogs, validations)
  5. Storage / Communication (local storage, interfaces)
  6. User Interface (display, operation, logging)

5 Data Flows

Source Destination Data Validations
Sensor Input SI-SIGNAL Raw ECG Format / range
SI-SIGNAL SI-ANALYSIS Filtered signals Quality flag
SI-ANALYSIS SI-UI Result parameters, diagnostic hints Consistency check
SI-ANALYSIS SI-DATA Analysis data / trends Integrity hash
SI-DATA External Systems Export ECG / parameters Authentication

6 Interfaces (Excerpt)

ID Direction Type Description Safety Aspect
IF-01 Sensor → SIGNAL Streaming Raw data channel Timings / dropouts
IF-02 SIGNAL → ANALYSIS API Call Filter result handover Data validity
IF-03 ANALYSIS → UI Event Analysis completed False alarm avoidance
IF-04 ANALYSIS → DATA API Parameter storage Integrity
IF-05 UI → SETTINGS Write Parameter changes Access control

7 Risk & Measure Assignment (Excerpt)

Risk ID Hazard Affected Software Item(s) Measure (Architecture) RMF Reference
R001 Electric shock (indirect: incorrect monitoring) SI-SEC, SI-ANALYSIS Integrity checks + watchdog RMF Section 6.1.1
R002 Misdiagnosis SI-ANALYSIS, SI-SIGNAL Algorithm validation + redundancy RMF Section 6.1.2
R005 Data loss SI-DATA Redundant storage / backup RMF Section 6.1.5

8 Quality & Design Principles

  • Defensive programming
  • Validation of every interface payload
  • Separation of safety-critical logic (Class C) from UI
  • Logging of safety-relevant states

9 Traceability Hooks

Software item IDs (SI-XXX) are used in SRS and test cases. Connection to risks (R###) and requirements (SR-###) maintained in traceability matrix.

10 Architecture Changes

Changes are subject to review by software architect + risk alignment. Document version updated (metadata script).

11 Annexes

Annex A: 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