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Spanish legislation

REGULATIONS WITH RANGE OF LAW

LAW 15/1980, creating the Nuclear Safety Council (CSN).

LAW 31/1995, on Prevention of Labor Risks;

REGULATIONS WITH THE RANK OF ROYAL DECREE

REAL DECRETO 39/1997, approving the Prevention Services Regulations;

REAL DECRETO 1029/2022 adopting the Regulation on health protection against the dangers of ionizing radiation.

REAL DECRETO 1085/2009, approving the Regulations on the installation and use of X-ray apparatus for medical diagnostic purposes.

REAL DECRETO 1836/1999, approving the Regulation on nuclear and radioactive facilities;

REAL DECRETO 601/2019, on justification and optimization of the use of ionizing radiation for the radiological protection of persons on the occasion of medical exposures.

REAL DECRETO 1308/2011, on physical protection of nuclear facilities and materials, and radioactive sources.

REAL DECRETO 229/2006, on the control of high activity encapsulated radioactive sources and orphan sources;

REAL DECRETO 673/2023, establishing the quality and safety criteria for nuclear medicine care units.

REAL DECRETO 1566/1998, which establishes the quality criteria in radiotherapy;

REAL DECRETO 1976/1999, which establishes the quality criteria in radiodiagnosis;

REGULATIONS WITH THE RANK OF ORDER

ORDEN ECO/1449/2003, on the management of solid waste materials with radioactive content generated in 2nd and 3rd category radioactive facilities in which non-encapsulated radioactive isotopes are handled or stored.

ORDEN of ETU/1185/2017, regulating the declassification of waste materials generated in nuclear facilities.

ORDEN IET/1946/2013, regulating the management of waste generated in activities using materials containing naturally occurring radionuclides.

CSN INSTRUCTIONS

INSTRUCTION number IS-01 of the CSN, defining the format and content of the individual radiological monitoring document (radiological card) regulated in Royal Decree 413/1997.

INSTRUCTION number IS-03 of the CSN, on qualifications to obtain the recognition of expert in protection against ionizing radiation.

INSTRUCTION number IS-05 of the CSN, defining the exemption values for nuclides as established in Tables A and B of Annex I of Royal Decree 1836-1999.

INSTRUCTION number IS-07 of the CSN, on fields of application of radioactive facility personnel licenses.

INSTRUCTION number IS-08 of the CSN, on the criteria applied by the Nuclear Safety Council to require, from the licensees of nuclear and radioactive facilities, specific advice on radiological protection.

INSTRUCTION number IS-16 of the CSN, regulating the periods of time for which documents and records of radioactive facilities must be kept on file.

INSTRUCTION number IS-17 of the CSN, on the homologation of training courses or programs for personnel who manage or operate X-ray equipment for medical diagnostic purposes and accreditation of the personnel of such facilities.

INSTRUCTION number IS-18 of the CSN, on the criteria applied by the Nuclear Safety Council to require the licensees of radioactive facilities to report radiological events and incidents.

INSTRUCTION number IS-28 of the CSN, on the technical specifications for operation to be met by second and third category radioactive facilities.

INSTRUCTION number IS-33 of the CSN, on radiological criteria for protection against exposure to natural radiation.

INSTRUCTION number IS-38 of the CSN, on the training of persons involved in the transport of radioactive material by road.

INSTRUCTION number IS-41 of the CSN, approving the requirements on physical protection of radioactive sources.

INSTRUCTION Nummer IS-42 des CSN, establishing the criteria for notification to the Council of events in the transport of radioactive material.

CSN GUIDELINES

GS 05-01 Revision 1 – Technical documentation for requesting the operating permit for radioactive facilities for handling and storage of unencapsulated radionuclides (2nd and 3rd category) (June 2005).

GS 05-02 Revision 1 – Technical documentation for applying for operating authorization for facilities for handling and storage of encapsulated sources (2nd and 3rd category) (July 2005).

GS 05-03 Revision 1 – Leakage test of encapsulated radioactive sources (February 2013)

GS 05-05 – Technical documentation to request authorization for construction and start-up of radiotherapy facilities (June 1998).

GS 05-06 – Qualifications for obtaining and using radioactive facility operating personnel licenses (June 1988).

GS 05-08 Revision 1 – Basis for preparing information relating to the operation of radioactive facilities (October 2014).

GS 05-09 Revision 1- Documentation to apply for authorization and registration of x-ray equipment sales and service companies (February 2022).

GS 05-10 Revision 1 – Technical documentation for requesting authorization to operate X-ray facilities for industrial purposes (November 2005).

GS 05-11 – Technical Aspects of Safety and Radiation Protection of Diagnostic Medical X-ray Facilities (October 1990)

GS 05-12 – Homologation of training courses for supervisors and operators of radioactive facilities (March 1998)

GS 05-14 Revision 1 – On Safety and radiation protection of industrial gammagraphy radioactive facilities (January 2015).

GS 05-15 – Technical documentation to request type approval of radioactive device (November 2001).

GS 05-16 – Technical documentation for requesting operating authorization for radioactive facilities consisting of equipment for the control of industrial processes (January 2001).

GS-05-17 – Calibration and verification of radiation protection instrumentation for the measurement of radiation and contamination in radioactive facilities (April 2023).

GS 06-02 – Radiation protection program applicable to the transport of radioactive materials (December 2002)

GS 06-05 – Guidance to assist in the application of the regulatory requirements for the transport of radioactive material (Updated according to ADR 2021) (June 2021).

GS 07-01 Revision 1 – Technical-administrative requirements for personal dosimetry services (February 2006)

GS 07-03 Revision 1 – Bases for the establishment of radiation protection services and technical units (June 1998).

GS 07-05 Revision 1 – Actions to be taken in the case of persons who have suffered a radiological accident (May 2005).

GS 07-10 – Plan de Emergencia Interior en instalaciones radiactivas (Mai 2009)

GS 09-02 – Management of solid waste materials with radioactive content generated in radioactive facilities (December 2001).

GS 11-01 – Guidelines on the competence of airborne radon measurement laboratories and services (January 2010)

GS 11-02 – Control of exposure to natural radiation sources (Enero 2012)

GS 11-03 – Methodology for radiological impact assessment of NORM industries (December 2012).

GS 11-04 – Methodology for the assessment of radon exposure in the workplace (December 2012).

CSN INFORMATION CIRCULAR

CSN CIRCULAR 7-2022, on the documentation to be submitted by licensees for the authorization of medical facilities with hybrid SPECT-CT equipment.

CSN CIRCULAR 4-2022 the documentation to be submitted by licensees for the authorization of medical facilities with hybrid PET-CT equipment.

CSN CIRCULAR 3-2022 on the documentation to be submitted by licensees for the authorization of medical facilities with high rate brachytherapy (HDR) equipment.

CSN CIRCULAR 2-2022 on standard format and content of the application for electron linear accelerators for medical use.

CSN CIRCULAR 5-2021 informing on incidents at radioactive facilities in the industrial gammagraphy sector

CIRCULAR of the CSN 4-2021 on the use of portable X-ray equipment for radiodiagnostic purposes.

CSN CIRCULAR CSN 2-2021 regarding the analysis carried out on the use of direct reading dosimeters and portable radiation monitors in the industrial gammagraphy sector.

CSN CIRCULAR 1-2021 on the competence to accredit or recognize the knowledge in radiological protection and instrumentation referred to in article 2p of RD 451-2020 on control and recovery of orphan radioactive sources.

CSN CIRCULAR 2-2020 on the practical application of royal decree 451-2020, of March 10, on the control and recovery of orphan radioactive sources.

CSN CIRCULAR 8-2019 on the procedure for the authorization of radiological protection technical units to provide advisory service in orphan recovery and other radioactive material out of regulatory control.

CSN CIRCULAR 7-2019 on the responsibilities of the hospital radiophysics specialist

CSN CIRCULAR 2-2019 on notification of on-site gammagraphy operations

CSN CIRCULAR 4-2018 on the procedure for the authorization of radiation protection technical units to provide natural radiation advisory service.

CSN CIRCULAR 1-2018 regarding the application of INSTRUCTION IS-41, of 26 July 2016, of the nuclear safety council, approving the requirements on physical protection of radioactive sources.

CSN CIRCULAR 8-2017 homologation of courses for obtaining radioactive facility operator and supervisor licenses.

CSN CIRCULAR 7-2017 to the radiological protection technical units in relation to the assignment of administrative doses at the facilities they serve.

CSN CIRCULAR 4-2017 on the content and scope of the periodic certificates of conformity required for medical radiodiagnostic facilities.

CSN CIRCULAR 1-2016 on acceptance testing prior to clinical use of X-ray equipment for medical diagnostic purposes.

CSN CIRCULAR 2-2015 to the radiological protection technical units in relation to the declaration of facilities using portable X-ray equipment in the field of dentistry.

CSN CIRCULAR 2-2014 to the radiation protection services regarding the allocation of administrative doses in 2013.

CSN CIRCULAR 3-2012 on dose analysis performed in the industrial gammagraphy sector

Community regulations

Community regulations

DIRECTIVE 2013/59-EURATOM, laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation, and repealing other Directives.

REGULATION 1493/93-EURATOM, relating to shipments of radioactive substances between Member States;

DIAGNOSTIC RADIOLOGY
DIAGNOSTIC RADIOLOGY
DIAGNOSTIC RADIOLOGY
DIAGNOSTIC RADIOLOGY
DIAGNOSTIC RADIOLOGY