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REGULATION
OF IONIZING RADIATION
IN MEDICAL FACILITIES
Asep Saefulloh Hermawan
Deputy Director for Licensing of Medical Facilities
Nuclear Energy Regulatory Agency of Indonesia
2
IONIZING RADIATION
Types of ionizing Rad:
• Alpha Particles travel short distance, have large
mass and cannot even penetrate a paper, only
become a hazard when inside the human body
because they will disrupting living cells.
• Beta Particles electrons or positrons travelling at
very high energies, travel further than alpha particles.
In fallout can cause severe burns to the skin, known
as beta burn.
• Gamma Rays and X-Rays (photons) radiation
consist of packets of energy known as photons.
Photons have no mass and travel in straight lines.
Photons can penetrate deeply into human body. 3
IONIZING RADIATION
Sources
• Radioactive Material (Co-60, Cs-137, Ir-192,
Ra-226, Kr-85, I-131, etc)
• Ionizing Radiation Generator (X Ray Machine,
Linear Accelerator, etc)
Biological Effect
• Stochastic Effect (Leukemia, Cancer, Genetic
Effect, etc)
• Deterministic Effect (Catharacs, Sterility, etc)
4
Ionizing Radiation Practices
• RADIOTHERAPY
• NUCLEAR MEDICINE
• DIAGNOSTIC RADIOLOGY
5
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• Medical speciality
involving the
application of
ionizing radiation for
treatment of disease
• In this treatment
ionizing radiation used
to kill cancer cell.
target Patient
Critical organ
Beam direction
RADIOTHERAPY
RADIOTHERAPY EQUIPMENT
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Medical speciality involving the
application of radioactive material
(radioisotope) for diagnosis and
treatment of disease.
NUCLEAR MEDICINE
NUCLEAR MEDICINE EQUIPMENT
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RADIOISOTOPE
GAMMA CAMERA
Field of medicine that uses imaging
exams and procedures to diagnose
patients using ionizing radiation (X-ray).
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Diagnostic Radiology
DIAGNOSTIC RADIOLOGY
EQUIPMENT
11
UU No. 10 Th. 1997
Ketenaganukliran
Executing Body (Art. 3)
To execute the use of Nuclear Energy
BAPETEN
Regulatory Body
Act No. 10, 1997 On Nuclear Energy
BATAN
Executing Body (R&D, promotion, application)
Established based on President Decree No 76 Th. 1998
NUCLEAR ENERGY REGULATORY
AGENCY
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BAPETEN
The control for the use of ionizing radiation
carried out by Badan Pengawas Tenaga
Nuklir (BAPETEN) as the regulatory body
The control implemented through:
Establishing Regulation
Licensing service
Performing Inspection
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Pedoman/Juklak
CONSTITUTION
ACTS
GOVERNMENT REGULATIONS
BAPETEN CHAIRMAN DECREE
GUIDANCES
HIERARCHY OF NUCLEAR ENERGY REGULATIONS
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Regulations of ionizing
radiation in medical
1 Act Act No. 10 /1997 on Nuclear Energy
2 Government
Regulation (GR)
• GR No. 33/2007 on Safety of Ionizing Radiation and
Security of Radioactive Sources
• GR No. 29/2008 on licensIng of Ionizing Radiation
Sources and Nuclear Material
• GR No. 56/2014 on License Fee
3 BAPETEN
Chairman Decree
(BCR)
• BCR No. 8/2011 on Radiation Safety in Diagnostic
Radiology
• BCR No. 17/2012 on Radiation Safety in Nuclear
Medicine
• BCR No. 3/2013 on Radiation Safety in Radiotherapy
• BCR No. 9/2011 on Compliance Testing of X-Ray unit
• BCR No. 16/2014 on Working License for Radiation
Protection Officer
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Article 17
Any use of nuclear energy shall be subjected for licensing, except in certain cases that will be further stipulated by Government Regulation
Article 43
Any person who acts contraverse to the provision pursuant to article 17 shall be punished by fine not more than Rp. 100.000.000 or imprisonment for not more than 1 year.
Act No 10 year 1997
On Nuclear Energy
LICENSING
Flow Chart of Licensing Process
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INSPECTION
• Performed by Inspector to ensure the
compliance of regulation.
• Conducted periodically or at any time, with
or without notofication
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Period of Inspection
No Risk Practices Period
1 High • Radiotherapy
• Nuclear Medicine
Every year
2 Midle Interventional Radiology Once every 2 year
3 Low Diagnostic Radiology Once every 3-4 year
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CHALLENGES
• Number of user increase every year
• Technology Development (Tomotherapy,
Boron Neutron Capture Therapy,
Mammography NM, etc)
• Public demand regarding transparancy and
accountability of public service
24
STRATEGIES
• Using online system for licensing
http://balis.bapeten.go.id
• Transfer knowledge with expert, vendor
• Intensive coordination with stakeholders
(ministry of health, customs, etc)
25
Thank You
Contact us
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