Operation of an X-ray facility or significant change to the operation Acceptance for dental, medical or veterinary X-ray facilities

    Do you want to operate dental, medical or veterinary X-ray equipment or make significant changes to it? Then you must notify the competent authority for radiation protection.

    Description

    Even if your dental, medical or veterinary X-ray equipment is not subject to approval, you must notify the competent authority for radiation protection in writing if you wish to operate the equipment or make significant changes to it or its operation.

    Significant changes to an X-ray facility can be, for example

    • Change of room
    • Structural changes to the room
    • Change of the image receiver

    Required documents

    • Proof of expertise in radiation protection in accordance with § 74 Radiation Protection Act in conjunction with § 47 Radiation Protection Ordinance. § 47 Radiation Protection Ordinance with proof of updating
    • Certificate and test report from experts on the radiation protection test
    • Proof of knowledge of radiation protection and of updates to this knowledge for personnel working at the X-ray facilities

    If necessary, you must also submit

    • Type approval certificate with confirmation of routine testing
    • CE certificate of conformity

    Prerequisites

    • You would like to operate an X-ray system,
      • whose X-ray source is type-approved.
      • whose manufacture and use falls under the Medical Devices Act.
      • which is used for the first time as a medical device and is not used in connection with medical exposures.
    • Or you wish to make significant changes to dental, medical or veterinary X-ray equipment.

    Deadlines

    You must submit the documents to the competent authority for radiation protection before commissioning the X-ray equipment and report the planned operation.

    Processing time

    2 to 4 weeks (If additional documents have to be requested and submitted, the processing time will be extended.)

    Notes (specifics)

    There are no indications or special features.

    Area of validity

    Hesse

    Official approval

    Officially approved by Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) on 31.01.2024

    Version

    Technisch erstellt on 25.05.2023

    Technisch geändert on 25.06.2024

    Keywords

    Vollschutzröntgengeräte, Tiermedizinisch, Hochschutzröntgengeräte, Röntgeneinrichtung, Bauartzulassung, Röntgengeräte, CE-Kennzeichnung, Anzeige, Zahnmedizinisch, Medizinisch, Schulröntgengeräte, Röntgenanlage

    Language version

    Deutsch

    Sprache: de

    Technisch erstellt on 07.06.2017

    Technisch geändert on 14.05.2025

    Englisch

    Sprache: en

    Sprachbezeichnung nativ:

    English

    Technisch erstellt on 07.07.2021

    Technisch geändert on 26.11.2019