DosimetryPreCalculator

1. Scope

This document defines requirements and functional behaviour for DosimetryPreCalculator used to control: Dosimetry Pre Calculator. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• DosimetryPreCalculator.exe — demo mode or help output.
• DosimetryPreCalculator.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Dosimetry Pre-Calculator — Radiopharmaceutical Activity and Dose Calculation
• ℹ️ Calculates activity at injection time, effective dose, and critical organ load.
• PatientID,Radiopharmaceutical,Radionuclide,Reference_Activity_MBq,Calibration_Time_ISO,Injection_Time_ISO,Patient_Weight_kg,Patient_Age_years,Min_Dose_MBq,Max_Dose_MBq,Max_Dose_per_kg_MBq
• Utility for medical physicists or NM physicians:
• • Decay Calculation: Radiopharmaceutical activity decreases over time. It is crucial to know the exact activity at injection time, not just at calibration.
• • Dose Estimation: Preliminary calculation of effective dose (mSv) and critical organ dose (mGy) using simplified MIRD coefficients. Helps assess radiation risk.
• ⚠️ IMPORTANT:

4. URS — user requirements

5. input.csv contract

PatientID,Radiopharmaceutical,Radionuclide,Reference_Activity_MBq,Calibration_Time_ISO,Injection_Time_ISO,Patient_Weight_kg,Patient_Age_years,Min_Dose_MBq,Max_Dose_MBq,Max_Dose_per_kg_MBq
PAT-001,F-18-FDG,F-18,400.0,2026-05-20T08:00:00,2026-05-20T10:30:00,75.0,45.0,200.0,400.0,5.5
PAT-002,Lu-177-DOTATATE,Lu-177,7400.0,2026-05-20T08:00:00,2026-05-20T14:00:00,80.0,60.0,7000.0,7800.0,100.0

6. FS — functional specification

7. output.json example

{
  "utilityId": "dosimetry-pre-calculator",
  "api": "Dosimetry Pre Calculator",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "PatientID",
      "value": "PAT-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "F-18-FDG",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclide",
      "value": "F-18",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Reference_Activity_MBq",
      "value": "400.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Calibration_Time_ISO",
      "value": "2026-05-20T08:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Injection_Time_ISO",
      "value": "2026-05-20T10:30:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Patient_Weight_kg",
      "value": "75.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Patient_Age_years",
      "value": "45.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

8. OQ/PQ test scenarios

9. QA/QC and change control

• Do not rename columns without validator update.
• Store input.csv, output.json, executable version and checksum.
• Before production use perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical radiopharmaceutical limits must be checked against the approved specification and local SOPs.