Dies ist die interne Entwicklungsumgebung des FIM Portals. Bitte nutzen Sie die produktive Umgebung.

Betrieb einer Röntgeneinrichtung oder wesentliche Änderung des Betriebs Erteilung für Dentalröntgeneinrichtungen

Hamburg 99006018001003 Typ 2a

Inhalt

Leistungsschlüssel

99006018001003

Leistungsbezeichnung

<div lang="en-x-mtfrom-de">Operation of an X-ray facility or significant change in operation License for dental X-ray facilities</div>

Leistungsbezeichnung II

<div lang="en-x-mtfrom-de">Apply for a permit to operate a dental X-ray facility or make a significant change to the operation</div>

Leistungstypisierung

Typ 2a

Begriffe im Kontext

<div lang="en-x-mtfrom-de">Register dental x-ray machine</div> (Synonym), <div lang="en-x-mtfrom-de">Report a change to your dental X-ray machine</div> (Synonym), <div lang="en-x-mtfrom-de">Report dental x-ray machine</div> (Synonym), <div lang="en-x-mtfrom-de">Change in dental x-ray machine</div> (Synonym)

Leistungstyp

nicht vorhanden

SDG Informationsbereiche

nicht vorhanden

Lagen Portalverbund

nicht vorhanden

Einheitlicher Ansprechpartner

Nein

Fachlich freigegeben am

22.08.2022

Fachlich freigegeben durch

nicht vorhanden

Handlungsgrundlage

Teaser

If you want to operate an X-ray device with a CE mark in a dental practice or MKG practice, you must report the operation 4 weeks before the first use.

Volltext

To operate a dental X-ray facility, you must register with the relevant authority.
The X-ray equipment can be put into operation once you have received confirmation of notification from the responsible authority.
If you do not receive a response within 4 weeks, you can put your indicated dental X-ray facility into operation.
If you plan to make significant changes to a dental facility, you must also notify the relevant authority in advance.

Erforderliche Unterlagen

  • Written notification according to § 19 StrlSchG signed by the radiation protection officer.
  • Approval certificate(s) from the radiation protection officer
  • In the case of group practices, a demarcation agreement does not apply to group practices
  • First acquisition of expertise in radiation protection
  • Update of the expertise in radiation protection no longer than five years old (key date regulation)
  • Confirmed notification according to § 129 Radiation Protection Ordinance (StrlSchV)
  • Expert examination of the X-ray equipment by an officially recognized expert.
  • When replacing an X-ray device, proof of the disposal of the old device is required.

Voraussetzungen

  • The notification must be made and signed by the radiation protection officer in accordance with § 69 StrlSchG.
  • The notification must be made 4 weeks before initial commissioning.

Kosten

The confirmation of the advertisement is subject to a fee. The fees are calculated according to the time spent in accordance with § 2 of the Hamburg fee schedule.

Verfahrensablauf

  • As the person responsible for radiation protection, you must complete the relevant notification form in full, sign it and send it to the responsible authority, including all documents listed in the notification.
  • If the documents or information required for processing are incomplete, the processing staff will contact you.
  • The responsible authority will check your advertisement and send you a confirmation of your advertisement.
  • The notification confirmation will be sent to you by post.
  • You will receive the fee notice by separate mail.
  • Once you have received confirmation of your notification, you are permitted to operate the X-ray equipment.
  • If you do not hear anything else from the responsible authority within 4 weeks of the notification, you may also put the dental X-ray device into operation.

Bearbeitungsdauer

Processing usually takes 4 weeks after all sub-algae have been submitted to the responsible authority.

Frist

Submit the notification at least 4 weeks before you wish to implement the planned significant changes.

Hinweise

The operation of a dental X-ray device without the required display is prohibited.

Rechtsbehelf

No

Kurztext

  • Apply for a permit to operate a dental X-ray facility or make a significant change to the operation
  • Operation of an X-ray facility or significant change in operation
  • Complete notification of the operation of dental X-ray facilities according to § 19 StrlSchG, including all required documents
or
  • Notification of a significant change to dental X-ray equipment § 19 StrlSchG,
  • Only the person responsible for radiation protection according to § 69 StrlSchG can file the report
  • You can find the notification form under Forms - hamburg.de
  • Confirmations of advertisements are subject to a fee.

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

Justice and Consumer Protection Authority

Formulare

nicht vorhanden