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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.
Your responsible authority
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Detailed 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
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Requirements
- 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.
- You would like to operate an X-ray system,
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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
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Deadline
You must submit the documents to the competent authority for radiation protection before commissioning the X-ray equipment and report the planned operation.
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Responsible authority
State Office for Occupational Safety, Consumer Protection and Health (LAVG)
- Legal basis
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Pointer
There are no indications or special features.
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Approved
Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV)
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Approved date
31.01.2024;20.12.2023