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2.1.7 Radioactive resources management rules
The general radioactive source management rules are
contained in section 4 of Chapter III of Title III of Book III
of the first part of the Public Health Code. These rules
are as follows:
•
No personmay transfer or acquire radioactive sources
without a license.
•
Prior registration with IRSN is compulsory for the
purchase, distribution, import andexport of radionuclides
as sealed or unsealed sources, or of products or devices
containing them; this prior registrationmakes it possible
to track the sources from their entry onto the market
until the end of their life. ASN resolution 2015-DC-
0521 of 8th September 2015 concerning themonitoring
and registration procedures for radionuclides in the
form of radioactive sources and products or devices
containing them, clarified the regulatory framework
with regard to the procedures for this registration of
movements and for the monitoring rules concerning
radionuclides in the form of radioactive sources (see
chapter 10).
•
Each establishment is required to ensure the traceability
of radionuclides in the formof sealed or unsealed sources
and of products or devices that contain them.
•
ASN must be notified in the event of loss or theft of
radioactive sources.
•
Users of sealed sources are obliged to have the expired,
damaged or end-of-life sources taken back by the
supplier, who is obliged to recover them.
On this latter point, Decree 2015-231 of 27th February
concerning the management of used sealed sources,
which came into force on 1st July 2015, modified
Articles R.1333-52 and R.1337-14 of the Public Health
Code, in order to enable those in possession of sources
to have the used sealed radioactive sources that have
expired or reached the end of their service life recovered
not only by their initial supplier, but also by any other
authorised supplier of radioactive sources or, as a final
resort, by Andra. The spirit of this modification is to
address the difficulties experienced by those in possession
of sources with regard to locating the original suppliers,
the cost of recovery and the monopoly enjoyed by certain
suppliers.
The conditions of implementation and payment of the
financial guarantees incumbent on the source suppliers
must be defined by an order from theMinisters responsible
for Health and Finance (Articles R. 1333-53 and
R. 1333-54-2 of the Public Health Code). In the absence
of such an order, the particular licensing conditions
established by the CIREA (Interministerial Commission
on Artificial Radioelements) in 1990 are taken up as
requirements in the licenses and are consequently
applicable to the licensees.
2.2 Protection of persons exposed
for medical and forensic purposes
Radiation protection for individuals exposed for medical
purposes is based on two principles mentioned in
paragraphs 1 and 2 of Article L. 1333-1 of the Public
Health Code respectively: justification of the procedures
and optimisation of exposure, which are under the
responsibility of both the practitioners prescribing
medical imaging examinations entailing exposure to
ionising radiation and the practitioners carrying out these
procedures. These principles cover all the diagnostic
and therapeutic applications of ionising radiation,
including radiological examinations requested for
screening, occupational health, sports medicine and
forensic purposes.
Inmedical imaging (see chapter 9), the final responsibility
for exposure lies with the practitioners performing the
exams. The rules applicable for the radiation protection
of patients set out in the Public Health Code are different
from those established for the protection of professionals,
set out in the Labour Code, even if the competence of
the physicians and professionals involved in delivering
the dose must cover both domains.
2.2.1 Justification of practices
Awritten exchange of information between the prescribing
practitioner and the practitioner carrying out the procedure
exposing the patient should provide justification of
the benefit of the exposure for each procedure. This
“individual” justification is required for each procedure.
Articles R. 1333-70 and R. 1333-71 of the Public Health
Code respectively require the publication of “prescription
of routine procedures and examinations” guides (also
called
“indication guides”
) and “performance of procedures”
guides (called
“procedure guides”
).
2.2.2 Optimisation of exposure
Optimisation inmedical imaging (radiology and nuclear
medicine) consists in delivering the lowest possible dose
compatible with obtaining a quality image that provides
the diagnostic information being sought. Optimisation
in therapy (external radiotherapy, brachytherapy and
nuclear medicine) consists in delivering the prescribed
dose to the tumour to destroy cancerous cells while
limiting the dose to healthy tissues to the strict minimum.
Standardised guides for conducting procedures using
ionising radiation have been prepared and are regularly
updated by health professionals, or are currently being
prepared, to facilitate practical application of the
optimisation principle (table 1).
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CHAPTER 03:
REGULATIONS
ASN report on the state of nuclear safety and radiation protection in France in 2015