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.
Basis for legal action
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
Keywords
Vollschutzröntgengeräte, Tiermedizinisch, Hochschutzröntgengeräte, Röntgeneinrichtung, Bauartzulassung, Röntgengeräte, CE-Kennzeichnung, Anzeige, Zahnmedizinisch, Medizinisch, Schulröntgengeräte, Röntgenanlage