National Diagnostic Reference Levels

sfda_gov_sa · regulation · processed · 3 chunks

SFDA

The Saudi National Diagnostic Reference Levels (NDRLs)
Version Number: 3.0
Version Date: 6/1/2025
"Translated Copy"

HSDA
Table of Content
Introduction 3
Purpose 3
Scope 3
Background 3
Requirements 4
Annexes 5
Annex (1): The Saudi National Diagnostic Reference Levels 6
Annex (3): List of Changes in the Previous Version 7

SFDA
Introduction
Purpose
The purpose of this document is to establish the Saudi National Diagnostic Reference Levels (NDRLs) in medical imaging applications and to define the related requirements.
Scope
This document applies to healthcare providers who use the following devices:
- Computed Tomography (CT) devices.
- General Radiology devices.
- Mammography devices.
- Nuclear Medicine devices.
Background
The SFDA has issued this document in reference to the following:
- Royal Decree No. (60057) dated 9/11/1441 AH, approving Saudi Health Council Resolution No. (3/88), which stated that the health care provider shall comply with the national diagnostic reference level issued by the SFDA.
- Article (26) of the "Medical Devices Law" issued by the Royal Decree No. (M/54) dated 6/7/1442 H stipulated that “The SFDA shall monitor the compliance of healthcare providers with technical regulations within healthcare facilities in order to ensure the safety and efficacy of medical devices in diagnosis and treatment”.
- Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ3).
Aming to protect patients from excessive and unjustified medical radiation doses while maintaining image quality and its diagnostic characteristics.
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SFDA
Requirements
1. Healthcare providers shall adopt the NDRLs related to medical imaging applications as specified in Annex (1).
2. Healthcare providers shall periodically send patient radiation dose data to the SFDA via email (NDRL@SFDA.GOV.SA), using the following forms:
- Data Collection Sheet for CT Scan.
- Data Collection Sheet for General Radiology.
- Data Collection Sheet for Mammography.
- Data Collection Sheet for Nuclear Medicine.
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SFDA
Annexes

SFDA
Annex (1): The Saudi National Diagnostic Reference Levels
<table><tr><td rowspan="13">CT</td><td colspan="4">A. Adult Patients (70 ± 15) Kg</td></tr><tr><td colspan="2">Protocols</td><td>CTDIvol(mGy)</td><td>DLP(mGy-cm)</td></tr><tr><td rowspan="2">Head</td><td>CT Brainw/ Contrast</td><td rowspan="2">55</td><td rowspan="2">1026</td></tr><tr><td>CT Brainw/o Contrast</td></tr><tr><td rowspan="2">Abdomen and pelvis</td><td>CT APw/ Contrast</td><td rowspan="2">14</td><td rowspan="2">706</td></tr><tr><td>CT APw/o Contrast</td></tr><tr><td rowspan="2">Chest</td><td>CT Chestw/ Contrast</td><td rowspan="2">12</td><td rowspan="2">430</td></tr><tr><td>CT Chestw/o Contrast</td></tr><tr><td colspan="4">B. Pediatric Patients (Head)</td></tr><tr><td>Age</td><td>Protocols</td><td>CTDIvol(mGy)</td><td>DLP(mGy-cm)</td></tr><tr><td rowspan="2">(0-5 Y)(6-15 Y)</td><td>CT Brainw/ Contrast</td><td>28</td><td>482</td></tr><tr><td>CT Brainw/o Contrast</td><td>42</td><td>697</td></tr><tr><td rowspan="3">General X-Ray</td><td colspan="2">ProtocolsAdult (70 ± 15) Kg</td><td colspan="2">DAP(Gy.cm2)</td></tr><tr><td colspan="2">Abdomen AP</td><td colspan="2">2.13</td></tr><tr><td colspan="2">CHEST PA / CHEST AP</td><td colspan="2">0.49</td></tr><tr><td rowspan="2">Mammography</td><td colspan="2">Protocols</td><td colspan="2">MGD (mGy)</td></tr><tr><td colspan="2">2DCom. Thickness (40-50) mm</td><td colspan="2">1.44</td></tr><tr><td rowspan="6">Nuclear Medicine</td><td colspan="3">ProtocolsAdult (70 ± 15) Kg</td><td>AdministeredActivity (mCi)</td></tr><tr><td colspan="2">Bone Imaging</td><td>Tc-99m - Phosphates &amp; Phosphonates</td><td>25</td></tr><tr><td colspan="2">Myocardial Perfusion</td><td>Tc-99m - Tetrofosmin (Rest + Stress)</td><td>40</td></tr><tr><td colspan="2">Thyroid Imaging</td><td>Tc-99m - Pertechnetate</td><td>5</td></tr><tr><td colspan="2">Renal Imagine</td><td>Tc-99m - DTPA</td><td>9</td></tr><tr><td colspan="2">Tumor Imaging</td><td>(PET) - F-18 FDG</td><td>9.5</td></tr></table>
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SFDA
Annex (3): List of Changes in the Previous Version
<table><tr><td>Number &amp; Date of the Previous Version</td><td>Changes Description</td></tr><tr><td>2.0 27/10/2022</td><td>- Amendment on the “Purpose”.
- Amendment on the “Scope”.
- Amendment on the “Background”.
- Amendment on the “Requirements”.
- Amendment on the &quot;Annex (2)
- Delete Annexes (1) and (3)</td></tr></table>
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