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2.1.5 Approval of radiation protection technical
supervision organisations
Technical supervision of the radiation protection
organisation, including supervision of themanagement of
radioactive sources and any associatedwaste, is entrusted
to approved organisations (Article R. 1333-97 of the
Public Health Code). The conditions and procedures for
approval of these organisations are set by ASN resolution
2010-DC-0191 of 22nd July 2010. ASN is responsible for
issuing these approvals. The list of approved organisations
is available on the ASNwebsite
(www.asn.fr).
The nature
and frequency of the radiation protection technical checks
are defined in ASN resolution 2010-DC-0175mentioned
in point 1.2.1.
2.1.6 The rules for the design of facilities
ASN technical resolutions, subject to approval by the
Ministers responsible for Radiation Protection, may be
adopted to determine the design and operating rules for
facilities in which sources of ionising radiation are used.
With regard to the design of the facilities, the
Union
technique de l’électricité
(UTE) conducted a revision of
standards NF-C 15-160 and the associated specific
standards (general installation rules for X-ray generators).
On the basis of this work, ASN has initiated an update
of the design and layout rules for facilities inside
which X-rays are produced and used. After several
consultations of GPRADE and GPMED, ASN adopted
resolution 2013-DC-0349 of 4th June 2013 laying
down minimum technical rules for the design of
facilities in which X-rays are present. This resolution
entered into force on 1st January 2014, subject to
certain provisions, for all facilities commissioned or
for which the calculation parameters are modified. This
resolution concerns industrial and scientific (research)
facilities such as industrial radiography using X-rays
in a bunker, veterinary radiology and medical facilities
such as conventional radiology, dental radiology and
scanners (see chapters 9 and 10).
This resolution also replaces theOrder of 30thAugust 1991
determining the installation conditions to be met by
X-ray generators.
On 23rd October 2014, ASN adopted resolution 2014-
DC-0463 concerning minimum technical rules for the
design, operation and maintenance of
in vivo
nuclear
medicine facilities.
The new rules set out in the above-mentioned resolution
of 23rd October 2014 replace rules existing since 1981;
they mainly concern the rules for the ventilation of
laboratories handling radiopharmaceuticals and hospital
rooms reserved for patients who have received therapeutic
treatment (in particular iodine-131).
2.1.3 The notification system
The list of activities requiring notification pursuant
to Article R.1333-19-1 of the Public Health Code was
updated in 2009 by ASN resolution 2009-DC-0146
of 16th July 2009, supplemented by ASN resolution
2009-DC-0162 of 20th October 2009. As in low-dose
medical radiology, radiology in veterinary practices is
now included in the activities requiring notification. It
is added to the list of non-medical activities requiring
notification, pursuant to Article R.1333-19-3 of the
Public Health Code.
ASN resolution 2009-DC-0146 of 16th July 2009 was
modified in 2015 (ASN resolution 2015-DC-0531 of
10th November) in order to add X-ray generators used
for irradiation of blood products.
ASN acknowledges receipt of the notification filed
by the natural or artificial person responsible for the
nuclear activity. As the maximum validity period for a
notification has been abolished, a new notification for
activities requiring regular notification only becomes
necessary if significant changes have been made to the
installation (replacement or addition of an appliance,
transfer or substantial modification of the premises or
change in party responsible for the nuclear activity).
Finally, the X-ray facilities used for forensic procedures
(for example, radiological examination to determine
the age of an individual, use of X-rays to detect objects
hidden within the human body, etc.), are regulated
by the licensing or notification system applicable to
facilities designed for medical uses, depending on the
type of equipment used (see point 2.2).
2.1.4 Licensing the suppliers of ionising
radiation sources
ASN resolution 2008-DC-0109 of 19th August 2008
concerns the licensing system for the distribution,
import and/or export of radionuclides and products
or devices containing them. This resolution covers
products intended for industrial and research purposes,
but also health products: drugs containing radionuclides
(radiopharmaceutical drugs, precursors and generators),
medical devices (gamma-ray teletherapy devices,
brachytherapy sources and associated applicators, blood
product irradiators, etc.) and
in vitro
diagnosis medical
devices (for radioimmunology assay).
ASN resolution 2008-DC-0108 of 19th August 2008
concerns the license to possess and use a particle
accelerator (cyclotron) and the manufacture of
radiopharmaceuticals containing a positron emitter.
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CHAPTER 03:
REGULATIONS
ASN report on the state of nuclear safety and radiation protection in France in 2015