European Radiation Protection Legislation: Guide for Hospitals and Radiotherapy Departments
Directive 2013/59/Euratom, quality assurance obligations and required equipment for compliance
📑 Table of Contents
Regulatory Framework for Radiation Protection
Radiation protection in Europe is governed by Directive 2013/59/Euratom, which establishes the Basic Safety Standards (BSS) for protection against ionising radiation. Each EU member state has transposed this directive into national law.
For radiotherapy departments, compliance with these standards is a legal obligation with direct consequences for non-compliance, including fines and licence suspension.
Directive 2013/59/Euratom: Core Principles
The directive is built on three fundamental principles of radiation protection:
1. Justification
Any practice involving ionising radiation exposure must be justified — benefits must outweigh risks.
2. Optimisation (ALARA)
Doses must be kept as low as reasonably achievable. In radiotherapy: maximum dose to tumour, minimum to healthy tissue.
3. Dose Limitation
Workers: 20 mSv/year (5-year average). Public: 1 mSv/year. Radiotherapy patients: no limit on prescribed dose.
Hospital Obligations
| Obligation | Responsible Party | Frequency |
|---|---|---|
| Quality assurance programme | Licence holder | Continuous |
| Equipment quality control | Medical physicist | Daily/Monthly/Annual |
| Individual staff dosimetry | Licence holder | Monthly |
| Patient dose assessment | Medical physicist | Per treatment |
| Dose records and archiving (5+ years) | Licence holder | Continuous |
| Continuing radiation protection training | Staff | Periodic |
| Incident notification | Licence holder | Immediate |
Mandatory Quality Control in Radiotherapy
Daily QA
Output, laser, distance indicator and safety checks before starting treatments.
Monthly QA
Symmetry, flatness, energy, MLC accuracy and CBCT image quality per TG-142 protocol.
Annual QA
Absolute calibration (TG-51), comprehensive mechanical and dosimetric parameter verification.
Patient-specific QA
Independent IMRT/VMAT plan verification before the first treatment fraction.
Required Equipment
☀️ Daily QA 4 Pro
Complete daily verification in under 5 minutes: output, symmetry, energy, field size.
View product →📊 IC Profiler
Ionisation chamber array for beam profiles, symmetry and flatness.
View product →🌀 ArcCHECK
3D cylindrical phantom for volumetric rotational plan verification.
View product →⚡ PC Electrometer
High-precision electrometer for absolute calibration per TG-51.
View product →How Interphysix Helps
QA Equipment
Full Sun Nuclear range for LINAC QA. Also Fluke Biomedical, Mirion, RaySafe and other leading brands.
Training & Support
Installation, initial training and ongoing technical support.
Technical Service
Preventive and corrective maintenance with original parts.
Need Equipment for Regulatory Compliance?
Interphysix helps hospitals and clinics meet radiation protection regulations with reference equipment and expert support.
Request a QuoteReferences
- Council Directive 2013/59/Euratom — EUR-Lex
- AAPM Task Group 142 — Quality assurance of medical accelerators. Med Phys. 2009
- IAEA Safety Standards Series No. GSR Part 3
Última actualização: 26/04/2026