Key Benefits:
Minister of Health and Sports,
Vu le Public Health Code, notably the 1st and 3rd of article R. 1333-19 and the 2nd of article R. 1333-43;
Vu la Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters,
Stop it!
Decision No. 2009-DC-0148 of the Nuclear Safety Authority of 16 July 2009 on the detailed content of the information to be attached to the declarations of nuclear activities referred to in 1° and 3° of article R. 1333-19 of the Public Health Code is approved.
This Order and the decision annexed to it are published in the Official Journal of the French Republic.
A N N E X E
DECISION N° 2009-DC-00148 OF THE AUTHORITY OF NUCLEAR SUGEES OF 16 JULY 2009 RELATING TO THE CONTAINED OF INFORMATION TO BE INTERESTED TO THE STATEMENTS OF NUCLEAR ACTIVITIES SUBMITTED TO 1° AND 3° OF THE ARTICLE R. 1333-19 PUBLIC CODE
The College of the Nuclear Safety Authority,
Considering the public health code, including articles L. 1333-4, R. 1333-17 to R. 1333-43;
Vu le Labour codeincluding articles R. 4451-1 to R. 4457-14;
Vu la Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters;
In light of Decision No. 2009-DC-00146 of the Nuclear Safety Authority of 16 July 2009 defining the list of electrical appliances generating X-rays held or used for biomedical research or medical, dental, forensic or veterinary diagnostics submitted to the reporting regime under Article 1 of R. 1333-19 of the Public Health Code,
Decides:
Article 1
This decision sets out the detailed content of the information to be attached to the declarations required under the point 2 of section R. 1333-43 of the Public Health Code for nuclear activities subject to declaration referred to in 1° and 3° of Article R. 1333-19.
Article 2
The statement shall consist of:
1. A form whose model is established by the Nuclear Safety Authority, available from the Nuclear Safety Authority, in particular on the www.asn.fr website and whose content is specified in annex 1 to this decision.
2. A supporting file, the content of which is specified in Appendix 2 to this decision.
Article 3
The form must be completed, signed by the registrant and transmitted to the NSO. The declarant shall make the supporting documentation available to the competent authorities.
Article 4
ASN may request additional information and carry out any post-report verification in the light of the information transmitted or the characteristics of electrical appliances generating X-rays.
Article 5
This decision shall take effect after its approval and publication in the Official Journal of the French Republic. It is published in the Official Bulletin of the Nuclear Safety Authority. The Director General of the Nuclear Safety Authority is responsible for its execution.
Done in Paris, July 16, 2009.
The College of the Nuclear Safety Authority,
Mr. P. CometsM. BourguignonM. Sanson
A N N E X E S
A N N E X E 1
COMPOSITION OF THE DECISION OF DECLARATION VISED TO 1° OF ARTICLE 2 OF DECISION N° 2009-DC-0148 OF THE AUTHORITY OF NUCLEAR SUGEES OF 16 JULY 2009 RELATING TO THE CONTAINMENT OF INFORMATION THAT DO NOT BE AGAINST
Part I
Information to be transmitted to ASN
as part of an initial declaration
I.
The registrant must specify whether the registrant makes a first statement or a new statement following a modification of the facilities in the cases provided for in theArticle R. 1333-39 of the Public Health Code.
II. - Declaring.
The name, first name, title and contact information of the natural person responsible for nuclear activity that makes the declaration of the proposed nuclear activity, known as the "registrant" in the subsequent decision.
III. - Establishment.
Information allowing identification of the establishment or legal entity where nuclear activity is carried out: name or social reason, legal status, address of the head office, SIRET or SIREN numbers, name and place of the service(s) where the facilities are established and used.
Location of the establishment in the event of other activities under theArticle R. 1333-17 of the Public Health Code They are exercised.
Name of the head of establishment where nuclear activity takes place.
IV. - Organization of radiation protection.
The name, first name and contact information of the employee(s) associated with the use of ionizing radiation.
The name, first name and contact information of the head of establishment in which the reporting activity is carried out.
The name, first name and contact information of the person(s) competent in the field of radiation protection and their status (internal or external PCR).
V. - Information on reported devices and the operation of the facilities hosting them.
The declarant provides a list of X-ray electrical appliances for each service or department of the facility. This list specifies for each device stated:
― the category of the device declared according to the list established by decision of the ASN pursuant to 1° of article R. 1333-19 of the Public Health Code or declared under the 3rd of the aforementioned article;
- the mark, the type;
the year of its construction;
- the name of the supplier or the assignor, its social reason, its address;
- the mode of use (fixed or mobile)
- the identification of services or premises where devices are used;
- if the devices are used in a mobile position, the declaration of attachment to a fixed facility;
- in the case of radiological vehicles, for medical radiodiagnosis facilities, the vehicle registration number and the list of travel departments;
- for devices that meet the 3rd of Article R. 1333-19, the intended use(s);
― for devices that meet the 3° of section R. 1333-19, the dose equivalent flow at any point located at a distance of 0.1 m from their surface accessible under normal conditions of use and because of their design.
VI. - Declarer's commitments.
6.1. Commitment to radiation protection of personnel.
The declarant undertakes to:
― to become aware of radiation protection regulations;
- what the employers of each worker using the appliances have designated a competent person for radiation protection;
- have instructions for the safety, use and maintenance of aircraft;
― assign, lend the apparatus to persons duly declared or authorized within the meaning ofarticle R. 1333-17 of the Public Health Code ;
– what any person handling the aircraft was previously trained in these manipulations, as well as radiation protection and actions to be taken in the event of an incident;
– leaving access to devices only to informed persons;
― to develop and update, as appropriate, the risk assessment related to the detention and use of aircraft, and to implement the consecutive delimitation and dosimetric monitoring of personnel;
― to develop and update, as appropriate, the forecasting analysis of workstations for aircraft-manipulating personnel, and to implement the consecutive classification and medical monitoring provisions;
- establish the program of so-called external and internal controls of radiation protection and atmosphere;
● Implement regulatory controls on radiation protection;
- take into account the observations made by the approved body or the NIHIR, either by taking the necessary steps to lift them or by argumenting the effective non-correction of these non-compliances;
- have safety and work instructions in connection with the use or detention of devices;
― making collective and individual protection equipment available;
• Prevent without delay, in the event of loss or theft of aircraft or in the event of an incident involving the aircraft, the department prefect and the territorially competent ASN division.
6.2. Safety of x-ray devices:
- in the case of use for biomedical research or medical, dental, forensic, medical or medical diagnostic purposes, the declarant certifies that the declared devices bear the CE marking for Directive 93/42 EEC (equipment put into service from 14 June 1998) or have been approved (equipment put into service before 13 June 1998);
- in the case of devices used for veterinary diagnostic purposes, the declarant certifies that the declared devices bear the CE marking for Directive 93/42 EEC (as of 14 June 1998) or have been approved (as of 13 June 1998) or conform to NF C 74-100 or any other equivalent standard of a Member State of the European Union;
- in the case of devices referred to in the 3rd of Article R. 1333-19, the declarant certifies that the declared devices conform to the standard NF C 74-100 or any other equivalent standard of a Member State of the European Union;
―in the case of devices used for veterinary diagnostic purposes or referred to in the 3rd of section R. 1333-19, the declarant certifies that the development of facilities where, at fixed stations, the equipment conforms to the standards of the NF C 15-160 series or that compensatory measures have been implemented.
Part II
Information to be transmitted to ASN as part of a new
statement following an amendment
The declarant recalls the elements requested at the points mentioned in part one.
The declarant will complete the statement by:
- the number of receipts from the previous declaration;
the date of the previous declaration;
― the nature of the changes involved (e.g. aircraft exchange, aircraft addition, aircraft off-duty, local transfer, substantial alteration of the premises, registrant change);
― in the event of a change of device (resuming or off-service), the name of the establishment having made the recovery or disposal of the device, its social reason, its address.
A N N E X E 2
COMPOSITION OF THE STATEMENT STATEMENT VISED TO 2° OF ARTICLE 2 OF DECISION N° 2009-DC-0148 OF THE AUTHORITY OF NUCLEAR SUGEES OF 16 JULY 2009 RELATING TO THE CONTAINMENT OF INFORMATION THAT DO NOT BE AGAINST THE DECLARATIONS OF NUCLEAR VIEW ACTIVITIES
The registrant shall, at all times, make available to the competent authorities and accredited bodies responsible for radiation protection controls or the Institute of Radiation Protection and Nuclear Safety the following documents and supporting documentation as required:
Rationale
1. A copy of the reporting form(s);
2. The declaration(s) issued by the NSA following each declaration.
Establishment
3. A document attesting to the legal status of the company (extract K-bis, USSRAF statement...).
Facilities and premises
4. In the case of a medical or dental radiodiagnostic, the identification sheet for each generator declared mentioning its brand, type, clean identification number, year of construction, with the lower part of the sheet completed and signed by the supplier or transferor of the device;
5. For each device model:
(a) A certificate from the manufacturer relating to the characteristics of the device (mark, type, serial number or identification, year of construction, year of commissioning);
(b) Certificate of conformity to (national or international) design and manufacturing standards;
(c) Description of the device (use with fixed or mobile position, beam accessibility, beam direction, diagram with tube location and beam orientation);
(d) Description of the conditions for the activation of the X-ray and the implementation of the devices;
(e) Description of the device locking system;
(f) The user manual, the maintenance and maintenance recommendations of the supplier of the device or, failing that, the user description and maintenance operations;
6. A description of the layout of all premises where fixed-station or common-purpose equipment are used: position of appliances, materialization of zoning, nature and thickness of walls, signalling devices, accessibility, safety device. This document will include an assessment of compliance with the NF C 15-160 series;
7. For mobile or transportable installations, the declaration of attachment to a fixed facility specifying as much as possible the location, frequency and foreseeable duration of these mobile uses, describe the storage and use conditions;
8. Description of provisions to prevent theft, loss or damage of aircraft;
9. Any supporting documentation relating to the recovery of devices or the removal of off-duty devices.
Qualification of users in medical, dental, biomedical and forensic activities
10. The updated list of practitioners, manipulators and users authorized to use the devices specifying their respective employers;
11. The qualification certificate(s) of the user practitioner(s) or their photocopy(s) (radiology option radiodiagnostic, issued by the doctor's board for the declaration of a mammography device;
12. Patient Radiation Protection Training Certificate (as of May 18, 2009).
Protection of workers
13. A copy of the certificate of success to the training of a person competent in radiation protection issued by a certified trainer, of the person designated by each employer after notice of the hygiene, safety and working conditions committee or staff delegates;
14. A copy of the formalized agreement between the head of institution and an external RCP to the establishment, if applicable;
15. The letter of appointment of the RCP, signed by the employer after notice to CHSCT or staff delegates and mentioning its missions;
16. The list and evidence of information and training of persons involved in controlled or controlled regulated areas (worksheets under three years, training support, etc.);
17. Any specific measures (scort, prevention plan...) relating to persons outside the company (co-activity, interim, accredited bodies...) ;
18. Assessing the risks associated with the use of devices (a document will describe and justify the assumptions used and the approach taken to establish the protections). This analysis will conclude the provisions for the delimitation of regulated areas and the dosimetric monitoring of staff;
19. Forecast analysis of staff workstations handling ionizing radiation sources. This analysis will conclude on the classification and medical monitoring of staff;
20. The annual dosimetric balance of the establishment and, where applicable, the operational dosimetry results of personnel subject to ionizing radiation;
21. The Radiation Protection Regulatory Control Program implemented in the facility (report checks, reception, pre-intervention, atmosphere, etc.) and the means used in this direction (e.g., apparatus used, radiation and range of energy detected);
22. Technical radiation protection monitoring reports referred to in articles R. 4452-12 and 13 of the Labour Code;
23. Any evidence demonstrating that it has been remedied to any deficiencies identified in the above-mentioned controls or an argument for the effective non-correction of these non-compliances;
24. The description of the proposed emergency situations related to aircraft (natural, probability of occurrence, associated abnormal exposure values, consequences within and outside the facility) and the steps taken to prevent and address them;
25. Safety instructions for radiation protection in the facility;
26. The list of available measuring devices (radiameters...) specifying their mark, type, date of their last calibration and check, and mentioning for each the type of radiation detected (with the corresponding energy ranges), if applicable;
27. Significant event reporting forms transmitted to the NSA, if applicable;
28. Reporting of significant events to the NSA, if applicable.
Patient radiation protection
29. The note specifying the modalities used to appeal to a person specializing in medical radiophysics and the nature of his or her activities as necessary. This document, to be signed jointly by this specialist, the declarer and the director of the institution, will be part of the plan describing the organization of the radiophysics to be established by the head of institution.
A N N E X E 3
DEFINITIONS
Accessible surface for devices responding to section R. 1333-19-3:
Any area accessible by all or part of a person (doigt, hand, whole body...), voluntarily or not, without dismantling or physical modification of the device or its accessories, including if it is unusual working conditions and not consistent with current practices.
Normal conditions of use:
Operating conditions fixed by the manufacturer or supplier of the device.
Done in Paris, January 29, 2010.
For the Minister and by delegation:
Director General
risk prevention,
L. Michel
