Type approval procedure pursuant to the German X-ray Ordinance (RoeV)

• Legal basis
• Categories of type-approved devices pursuant to X-ray Ordinance
• Type approval procedure pursuant to X-ray Ordinance
• Persons in charge
• Administrative requirements
• Quality control, designation of a qualified expert
• Technical requirements
• PTB Safety guideline
• Type approval modifications
• Limitation and extension of a type approval
• Costs

Legal basis

The operation of X-ray assemblies is subject to licensing pursuant to the German X-ray Ordinance (§ 3 no. 1 RoeV). License is granted by the German Federal States’ authorities responsible for the execution of the X-ray Ordinance.

However, the X-ray Ordinance permits exceptions to this general rule in the case of devices which were granted a type approval according to § 8 (1) X-ray Ordinance. Type approvals in the field of radiation protection confirm that a certain level of radiation protection is achieved by a particular construction of the device – provided that the use of the device is justified. Unjustified uses are listed in Annex 5, part B X-ray Ordinance. The administrative approval covers the entire type, thus, a specific approval for individual equipment is not required.

The type approval of X-ray devices for non-medical purposes as well as of parasitic X-ray emitters (equipment with unintended X-ray emission) is regulated by §§ 8 to 12 together with Annexes 1 and 2 of the X-ray Ordinance – RoeV (Ordinance on the Protection against Damage and Injuries Caused by X-rays). According to § 8 (6) RöV, the Federal Office for Radiation Protection (BfS) is the competent authority for granting these type approvals. To this end, BfS commissions the Physikalisch-Technische Bundesanstalt (PTB) with performing technical type tests.

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Categories of type-approved devices pursuant to X-ray Ordinance

The X-ray Ordinance stipulates that the following categories of devices can be granted a type approval if certain technical and radiological requirements relating to the envisaged use of the device are fulfilled.

• Veterinary X-ray equipment
• X-ray tube housing assemblies for non-medical purposes with an acceleration voltage of up to 500 kV
• Basic protection devices
• High protection devices
• Full protection devices
• School X-ray devices
• Parasitic X-ray emitters, if the voltage for accelerating the electrons exceeds 30 kilovolt (kV).

The relevant requirements for each category are set out in Annexes 1 and 2 X-ray Ordinance. These requirements refer to design- and safety-related conditions, in particular for the dose rate in the close vicinity to the device. A granted type approval is the precondition to operate the devices without further licensing (instead of this a notification to the competent authority is mandatory), or even without licensing or notification (only valid for parasitic X-ray emitters). Details on the operation of X-ray tube housing assemblies, X-ray devices and parasitic X-ray emitters are laid down in §§ 3 to 5 of the X-ray Ordinance.

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Type approval procedure pursuant to X-ray Ordinance

The above devices can be type-approved pursuant to § 8 (1) X-ray Ordinance following an application submitted by the manufacturer or distributor if the requirements set out in Annex 1 and/or 2 of the X-ray Ordinance are complied with. These requirements are mostly technical requirements and serve to limit the dose rate of the radiation field in the close vicinity to the device.

BfS as the competent authority commissions the Physikalisch-Technische Bundesanstalt (PTB) with performing the type tests. The applicant submits the relevant prototypes to PTB for testing, as requested. BfS validates the results of the type test and decides on whether or not a type approval can be granted.

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Persons in charge

Depending on the application, either the manufacturer or the distributor holds a type approval for a device. The manufacturer is generally represented by company management and the persons in charge of the manufacturing process; the distributor is represented by company management. Type approvals can only be granted if there are no concerns as to the reliability of the manufacturer and/or distributor and the technical competence of the persons in charge of the manufacturing process (§ 8 (3) no. 2 X-ray Ordinance).

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Administrative requirements

The applicant shall submit the following documents to BfS together with the application for type approval and the completed form sheet "Administrative details" in single copy:

• A short covering letter describing the purpose of the request and giving contact details (address, phone number, email)

• References provided by the manufacturer or distributor pursuant to § 8 (3) no. 2 X-ray Ordinance

  • a copy of an excerpt from the commercial register and/or a license granted by the competent authority of the Federal State.
  • a list of the applicant’s representatives (company management in most cases) including the respective Certificates of good conduct to be presented to public authorities pursuant to § 30 (5) of the Federal Central Register Act
  • information on the technical experience of the person in charge of the manufacturing process
• Designation of a qualified expert charged with supervising the quality control (§ 9 no. 2 X-ray Ordinance)
• A quality control concept describing the principle of the intended quality assurance pursuant to § 9 no. 1 X-ray Ordinance (test instructions contained in the existing quality assurance system, if applicable, ISO 9001 certificate or similar proof)
• Copies of granted licenses, certificates or experts' inspection reports (e.g. from outside Germany).

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Quality control, designation of a qualified expert

The type approval holder must ensure that only devices conforming to the granted type approval are put into circulation. The type approval holder shall perform a quality control in order to ensure that the essential radiation protection features in the manufactured devices are consistent with the approved prototype and the approved documents. Such quality control shall be monitored by a qualified expert to be determined by the BfS (§ 9 X-ray Ordinance).

If the type approval holder is the manufacturer of the device, a staff member of the manufacturer is usually appointed as qualified expert. If the type approval holder is the distributor of the device, the qualified expert may be

• a qualified member of the distributors staff or
• an external expert (e.g. a member of staff of the manufacturer or an independent expert pursuant to § 4a X-ray Ordinance).

The competent authority shall be informed of the expert's name, area of responsibility and qualification.

If the qualified expert terminates his responsibilities or further qualified experts are to be appointed, the competent authority shall be informed in due time in order to reassign the responsibilities.

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Technical requirements

The requirements of the technical documentation are stated in the respective form sheets "Technical details" relating to the different type categories of devices. The completed forms shall be submitted to the approval authority in duplicate, together with any relevant enclosures and drawings. The following data shall be disclosed:

• Description, technical documentation and drawings of the prototype presented for testing
• Explanation on the operating principle
• Information on design, dimensions and material of the essential radiation protection features
• In the case of basic protection devices, high protection devices, full protection devices and school X-ray devices: detailed information on the design of the safety components which must conform to the PTB guideline (see below), including presentation of appropriate expert reports (e.g. TÜV reports), if available
• Operational instructions in German language containing reference to the radiation protection measures (§ 9 no. 5 X-ray Ordinance).

During the type testing process, PTB may require further documentation. In this case the applicant will be requested to submit such documents.

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PTB Safety guideline

Particular safety systems are required for the type approval of high protection devices and full protection devices as well as for school X-ray devices. These requirements are described in a guideline by PTB which is made available to manufacturers and experts. The guideline provides detailed information on requirements for hardware and software components in order to ensure the required level of safety.

Publication:

Report PTB-Dos-49, December 2005, Stefan Neumaier, Ulrich Grottker, Harald Dombrowski, Alexander Höhne, Roland Zwiener, Peter Ambrosi, „Sicherheitsvorrichtungen von Hochschutzgeräten, Vollschutzgeräten und Schulröntgeneinrichtungen – Anforderungen für die Bauartprüfung nach der Röntgenverordnung“, 42 pages, ISSN 0172-7095, ISBN 3-86509-446-5 available at Wirtschaftsverlag NW, Verlag für neue Wissenschaft GmbH, Bürgermeister-Smidt-Str. 74-76, D-27568 Bremerhaven, www.nw-verlag.de.

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Type approval modifications

Modifications to the radiation protection-relevant features of type-approved devices require an amendment to the approval certificate which must be applied for at BfS.

The applicant shall submit documents to the competent authority which contain a complete and unambiguous description of the technical modifications with respect to the essential radiation protection features of the type approved device, together with a free-form application for a type approval modification. Any drawings submitted shall comply with the applicable standards for technical documentation.

The competent authority shall also be informed on changes of the company´s trade name, the persons in charge, the qualified experts etc. by submitting relevant documents.

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Limitation and extension of a type approval

The type approval shall be valid for a maximum of ten years. Once the approval period has expired, devices must not be newly put into circulation as "type-approved" devices. The approval period may be extended on request.

The free-form application for an extension of the type approval shall be submitted in due time, i.e. at least 3 months before expiration of the approval period. The forms on administrative and technical details of the devices shall be enclosed. An updated version of all relevant drawings used for type approval shall also be enclosed (in duplicate).

Applications for an extension of the type approval will be checked for compliance with the legal requirements valid at the time of the application. It may be necessary that PTB performs type tests in order to evaluate if the device conforms to the current state-of-the-art. If all requirements are fulfilled, BfS will extend the type approval.

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Costs

The costs arising in connection with granting and amending type approvals shall be borne by the applicant (according to § 21 (1) no. 4 of the German Atomic Energy Law - AtG). The costs – fees and expenses – will be determined separately by BfS and PTB according to the applicable scales of fees. Applicants from outside Germany who have not been in contact with the BfS before may be asked to provide a reasonable payment in advance. The same method can be applied for German applicants who did not pay their debts or paid their debts with a significant delay in the past.