ASN Report 2017

98 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 03  - Regulations radiopharmaceutical drugs are prepared and the hospitalisation rooms for patients having received a therapeutic treatment (more particularly iodine-131). 2.1.7 Radioactive sources management rules The general radioactive source management rules are contained in section 9 of Chapter III of Title III of Book III of the first part of the Public Health Code. These rules are as follows: ཛྷ ཛྷ No personmay transfer or acquire radioactive sources without a license. ཛྷ ཛྷ Prior registration with the IRSN is compulsory for the acquisition, distribution, import and export of radionuclides as sealed or unsealed sources, or of products or devices containing them; this prior registration makes it possible to track the sources from their entry onto the market until the end of their life. ཛྷ ཛྷ Each establishment is required to ensure the traceability of radionuclides in the form of sealed or unsealed sources and of products or devices that contain them. ཛྷ ཛྷ ASNmust be notified in the event of loss or theft of radioactive sources. ཛྷ ཛྷ All users of sealed sources are obliged to have the expired, damaged or end-of-life sources taken back by a qualified supplier, or by Andra. ཛྷ ཛྷ A supplier is required to recover any source it has distributed if the party in possession of said source so requests. ASN resolution 2015-DC-0521 of 8th September 2015 concerning the monitoring 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). FOCUS The new ASN resolution of 13th June 2017 Experience feedback regarding the difficulties with implementing the resolution of 4th June 2013 showed firstly that the March 2011 version of standard NF C 15-160 mentioned in the resolution did not apply to all the existing situations, and secondly that the identification and justification of equivalent provisions - a possibility provided for in this resolution - posed technical application problems for the manufacturers, suppliers and users. Given this situation, ASN worked on a revision of this resolution which is no longer based on standard NF C 15-160, but sets the radiation protection objectives to be achieved by adopting a graded approach according to the risk generated. In the new resolution, the requirements relative to the control of radiological risks remain similar but are written so as to meet more clearly formulated objectives. The draft text was posted on the ASN website for public consultation from 2nd August to 30th September 2016. More than forty or so contributions have been made. They are in favour of the new draft and more specifically enabled certain points to be clarified. This new resolution entered into force on 1st October 2017, without introducing any additional requirements for the installations already compliant with the previous resolution. It is applicable: ཛྷ ཛྷ to workplaces in which at least one X-ray generator is used (whether or not intentionally), whether or not mobile and used permanently or frequently in the same room; ཛྷ ཛྷ chambers and conveyances within which such devices are used. The resolution covers: ཛྷ ཛྷ the sizing of the biological protections of the premises for which the radiological zoning objectives are specified in the text; ཛྷ ཛྷ signalling of the risk at each access point and inside the premises; ཛྷ ཛྷ safety (emergency stop devices, devices interconnecting operation to points of access and access actuation systems); ཛྷ ཛྷ the content of the report guaranteeing compliance with the provisions of the resolution. FACILITIES conformity calendar Commissioning Existing compliant facilities Other existing facilities 16th October 2017 1st July 2018 If modification Without modification Applicable requirement 2013-DC-0349 Applicable requirement 2017-DC-0591 Either of the requirements