Spain · National · Royal Decree

Royal Decree 1085/2009 · X-rays: worker protection

In force, amended in 2022; read with the current ionising-radiation framework

Current official Spanish title: Real Decreto 1085/2009, de 3 de julio, por el que se aprueba el Reglamento sobre instalación y utilización de aparatos de rayos X con fines de diagnóstico médico.

On this page
  1. What it regulates
  2. Who it applies to
  3. Key provisions
  4. History and versions
  5. Transitional provisions and application notes
  6. Official BOE legal relationships
  7. Official sources
  8. Explore the concepts in Sabentis Explore

What it regulates

It regulates diagnostic X-ray installations and personnel competence. This OSH selection focuses on assessing and controlling occupational exposure, maintaining a written radiation-protection programme, monitoring doses and working conditions, and demonstrating competence.

Who it applies to

OSH selection for medical diagnosis, including medico-legal and veterinary use: additional provision one and Articles 18, 19, 22 and 23, with a qualification concerning Article 12. Clinical guidance on patient exposure is excluded. Therapy equipment and other excluded generators follow a different regime.

Key provisions

Article 19 requires a written, up-to-date programme before operation, covering risk assessment, workplace classification and signs, access control, worker classification and procedures known to personnel.

Article 19

Article 18(d) requires radiation-level monitoring at workstations and adjacent areas at least annually, and when conditions change or irregularities arise. A radiation-protection service or technical unit performs the monitoring and certifies the results.

Article 18

Article 19(3) requires dose and health monitoring and maintained records. Doses are determined monthly; area dosimetry for category B requires the specified written protocol and conditions and is not a universal substitute for personal dosimeters.

Article 19

Article 22 requires competence both for the person directing the installation and for operators working under supervision. The accredited director supervises the radiation-protection programme; both must follow the specified working procedures.

Article 22

Article 23 governs accreditation by the Nuclear Safety Council and recognised training routes. Accreditation demonstrates radiation-protection training; it does not replace qualifications or professional requirements for the relevant technique.

Article 23

History and versions

Initial publication: 18/07/2009 · Initial entry into force: 19/07/2009

BOE-A-2009-11932

Published on 18 July 2009 and effective from 19 July 2009. Royal Decree 1029/2022 amended Article 12(4) and (5) from 22 December 2022. It also replaced the general ionising-radiation framework and redirected references to the previous regulation. Unamended preventive articles must be read within that current framework.

Original preventive duties and competence requirements, effective 19 July 2009.

Publication: 18/07/2009 · Effective date: 19/07/2009

BOE-A-2009-11932

Royal Decree 1029/2022, final provision one: amends Article 12(4)–(5), requiring registration notification before operation. Its sole additional provision redirects references to the previous radiation regime. Effective from 22 December 2022.

Publication: 21/12/2022 · Effective date: 22/12/2022

BOE-A-2022-21682
Text versions of the selected OSH provisions

The table is limited to the occupational safety and health provisions covered by this record. A text version may amend only other paragraphs of the same article; the history explains the occupational changes. Changes to other subjects can be consulted in the BOE.

OSH selection for medical diagnosis, including medico-legal and veterinary use: additional provision one and Articles 18, 19, 22 and 23, with a qualification concerning Article 12. Clinical guidance on patient exposure is excluded. Therapy equipment and other excluded generators follow a different regime.

PublicationEffective dateOfficial referenceAffected provisions
18/07/200919/07/2009BOE-A-2009-11932Additional provision first, Transitional provision second, Article 12, Article 18, Article 19, Article 22, Article 23
21/12/202222/12/2022BOE-A-2022-21682Article 12

Transitional provisions and application notes

  • Additional provision one preserves the OSH Act and its implementing rules alongside specific radiation provisions. Installation registration alone does not establish compliance with every employer prevention duty.

    Additional provision first
  • The 2009 text retains references to Royal Decree 783/2001. The sole additional provision of Royal Decree 1029/2022 redirects them to corresponding provisions of the new regulation; the 2001 instrument was repealed. Historical dose limits must not be treated as current.

    Official reference
  • Since the amendment effective on 22 December 2022, the holder may not put the installation into service until receiving the regional registration notification. Merely submitting the declaration is insufficient.

    Article 12
  • The year granted in 2009 to already registered installations to implement their radiation-protection programme was an initial transition. It does not provide a fresh period for an installation operating today.

    Transitional provision second

Official BOE legal relationships

This record covers the history of the selected occupational safety and health provisions. The official analysis also provides the relationships affecting other subjects in the legislation.

Official BOE legal relationships

Official sources

Official sources checked on 14/11/2026. Updating a database record does not by itself mean that the legislation has been amended.

  1. BOE-A-2009-11932
  2. BOE-A-2009-11932
  3. ELI identifier
  4. BOE-A-2022-21682

Official sources checked on 14 November 2026. The original publication and subsequent provisions determine the legal scope; consolidation, where available, is informative. The editorial history focuses on OSH-relevant relationships and does not replace the sources.

Sabentis editorial translation; it is not an official translation and does not replace the official text.

Editorial information

Publication date: 14 November 2026.

Editorial responsibility: Sabentis editorial team.

Editorial review by Pablo RodríguezLinkedIn

Executive Vice President of the International ORP Foundation and Chief Financial Officer of Sabentis.

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