Source: http://www.bfs.de/EN/topics/ion/daily-life/type-approvals/strlschv/strschv-faq.html?nn=6011534
Timestamp: 2018-11-16 10:02:40
Document Index: 266573048

Matched Legal Cases: ['§ 8', '§ 25', '§ 25', '§ 27', '§ 106', '§ 107', '§ 30', '§ 27']

BfS - ... pursuant to Radiation Protection Ordinance - Type approvals pursuant to the Radiation Protection Ordinance (StrlSchV) Frequently Asked Questions
Type approvals pursuant to the Radiation Protection Ordinance (StrlSchV) Frequently Asked Questions
1. What is the aim of type approvals pursuant to the Radiation Protection Ordinance?
2. What are the fundamental considerations with respect to type approvals pursuant to the Radiation Protection Ordinance?
3. What are the main requirements for the granting of type approvals?
4. Who is responsible for granting type approvals?
5. How and where will the type be evaluated?
6. Is it possible to modify the requirements for the granting of type approvals?
7. What is to be observed for leakage tests on type-approved devices?
8. Can type approvals be granted for devices if the activities of the inserted radioactive substances are below the exemption limit?
9. Is it possible to modify the type of type-approved devices?
10. What is to do in the case of changes of the trade name or the persons in charge?
11. Is it possible to transfer type-approved devices to third parties?
12. Is it possible to extend the approval period?
13. What is stipulated for the further operation of devices after the approval period has expired?
14. What happens to type-approved devices when they are no longer in use?
Devices that have been granted a type approval pursuant to the Radiation Protection Ordinance (StrlSchV) may be used in a mainly professional context without license and without notification to the competent authority of the Federal state. Type-approved devices are characterised by a high level of radiation protection for the operation of such devices. Regulatory control focuses on the approval of the entire type so that individual devices are not required to be specifically approved or evaluated by the competent authorities of the Federal states.
It was considered on an international level that devices bearing a low radiological risk should be released from regulatory control so that controls would not have to be performed where they are unnecessary. This principle has been implemented in § 8 StrlSchV as a regulatory measure for allowing the handling of devices without authorization. According to these provisions, radioactive sources may be handled without licensing if the sources’ activities do not exceed the exemption limits set out in Annex III, Table 1, Column 2. The exemption limit conforms to a certain level of activity below which the radiological risk arising from the handling of the radioactive source is marginal.
If a radioactive source is enclosed and inserted into a device and the design of the device ensures protection, the radiological risk arising from the handling of this device may even be marginal although the substance’s activity exceeds the exemption limit. In this case the device may be released from regulatory control by being granted a type approval. An essential element of the type approval procedure pursuant to §§ 25 to 27 StrlSchV is the evaluation of the relevant preconditions by BfS as the competent authority.
The requirements for the granting of type approvals for devices with inserted radioactive substances are set out in Annex V part A of the Radiation Protection Ordinance (StrlSchV) in its current version – which is, as before, in conformity with the provisions of the EURATOM basic standard (Directive 2013/59/EURATOM as of 5th of December 2013).
The Radiation Protection Ordinance does not distinguish between different categories of type-approved devices. The activity of the inserted radioactive substance is generally restricted to the tenfold of the exemption limit (at maximum). The radioactive substance must be enclosed and covered so that it cannot be touched. The ambient equivalent dose rate (local dose rate) at a distance of 0.1 m from the touchable surface must not exceed 1 microsievert per hour (1µSv/h) under standard operating conditions. The applicant shall additionally furnish proof that a reasonable, standard-based quality assurance system is established in the manufacturing process of the devices and the inserted radiation sources. This requirement is supposed to ensure that the manufactured devices comply with the approved type and that their quality remains constant. A take-back concept must be presented describing where the devices and/or the radiation sources will remain when they are no longer in use.
According to § 25 (7) StrlSchV, the Federal Office for Radiation Protection (BfS) is responsible for granting type approvals. Please send applications for type approvals together with the required form sheets to the following address:
- Type approvals -
Postbox 10 01 49
BfS is responsible for the type tests since 4 October 2011. The Federal Institute for Materials Research and Testing (BAM) is consulted for an assessment of the tightness, material selection and the design of the components enclosing the radioactive source as well as for an evaluation of quality assurance aspects.
The applicant shall submit the relevant prototypes to the testing authorities, as requested.
In exceptional cases the approval authority may allow variations of individual requirements set out in Annex V part A (no.1, letter a, no. 3 or 4) StrlSchV. However, the required level of radiation protection must be ensured by design, material and function of the device under any circumstances.Under particular conditions it may be possible that a type approval is granted for a device into which a radioactive substance is inserted even if this substance is not tightly enclosed on all sides but is covered so that it cannot be touched. This is the case, for example, in some ion mobility spectrometers. However, the design of the device or of the gas circuit must limit the release of the radionuclide in such a way that the relevant tightness requirements are complied with. The radiation source itself must be integrated in such a way that it is protected from external influences and damage as well as from the impact of corrosive gases.BfS as competent authority for granting type approvals is also entitled to schedule longer or shorter intervals for the mandatory regular leakage tests to be performed on the radiation source. Type approval may even be granted under particular conditions if the activity of the inserted radioactive substance exceeds the tenfold of the exemption limit.
Type-approved devices must be designed in such a way that no further leakage tests are necessary apart from the acceptance test carried out by the manufacturer and the mandatory leakage tests to be performed in ten-year intervals (according to § 27 (6) and Annex V part A no. 3 StrlSchV).
As far as the term of use of the device set out in the approval certificate is limited to 15 years and the tightness of the radiation source is ensured for this period of time – which is shown, for example, in expert reports submitted by qualified experts or by the Federal Institute for Materials Research and Testing (BAM) – it may be possible to have no leakage tests for the entire term of use. The operator of the device may also be released from mandatory leakage tests – apart from the acceptance test carried out by the manufacturer – if the radiation source used in the device has at least been given an ISO classification according to the requirements of DIN ISO 2919 Table 3 and if this is reasonable under consideration of the material, design and operating conditions of the radiation source.
No, type approvals pursuant to StrlSchV are not intended for devices with inserted radioactive substances whose activities are below the exemption limit as set out in Annex III, Table 1, Column 2 StrlSchV.
It may be possible to apply for an approval pursuant to §§ 106 and 107 StrlSchV for the production of a device as a consumer good, in particular as a “consumer good which is used mainly in a professional and not in a domestic context” (§ 107 (2) StrlSchV). The production of this group of consumer goods may be approved under particular conditions if the use of the radioactive substance is justified. The relevant authorities in this case are the competent authorities of the Federal states responsible for the execution of the Radiation Protection Ordinance.
Yes. 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 type approval holder shall submit technical documents to BfS which contain a complete and unambiguous description of the planned modifications, together with a free-form written application for a type approval modification. BfS decides – following consultation of the Federal Institute for Materials Research and Testing (BAM), as the case may be – if the modified device must undergo another fundamental evaluation so that it can be determined if the approval requirements are complied with. If the requirements are fulfilled, the type approval certificate will be amended. The essential content of the modification will be published in the Federal Gazette.
An individual type-approved device which has already been taken into operation must not be changed with respect to its radiation protection-relevant features.
The approval authority must immediately be informed of changes of the type approval holder’s trade name, the manufacturer, the persons in charge etc. The required amendments to the approval certificate shall be applied for at BfS in writing. Such application shall be accompanied by the required official or notarised documents, for example an excerpt from the commercial register, shareholders' agreements, a Certificate of good conduct to be presented to public authorities pursuant to § 30 (5) of the Federal Central Register Act, qualification certificates.
The operator of a type-approved device is entitled to transfer the device to third parties. A copy of the type approval certificate and it´s amendments has to be handed over to the new owner (”acquirer”) together with the technical documents. The acquirer is entitled to continue the operation of the device provided that the requirements of the granted type approval are met.
The type approval is granted for a maximum period of ten years. The approval period may be extended on request.
A free-form application for an extension of the type approval shall be submitted to BfS at least three months before expiration of the approval period. Such application shall be accompanied by the completed administrative and technical details form sheets. The underlying type drawings in their current version shall also be submitted (in duplicate).
In the case of an application for an extension of the type approval it has to be verified that the device conforms to the state-of-the-art according to the legal and technical requirements valid at the time of the application. Another fundamental type testing process performed by BfS and BAM may be required. If all requirements are fulfilled, BfS will extend the type approval.
An extension of the type approval is generally not possible as soon as the scheduled approval period has expired. In this case the type approval holder will have to submit a new application for a type approval, if desired.
Once the approval period has expired, devices must not be newly put into circulation as "type-approved" devices.
Type-approved devices that have been put into circulation and whose approval period has expired may continue to be operated – provided that the requirements of the expired type approval are met – if the essential radiation protection-relevant features are compliant and the devices are not damaged, unless the approval authority has announced that sufficient protection against damage from radiation is not ensured and that the device must no longer be operated.
According to § 27 (7) StrlSchV the holder of a type-approved device must return such device immediately after the end of use, for example when the planned period of use as indicated in the type approval certificate has been expired. If this is not possible or would require an unreasonable effort, the device and/or the radiation source shall be handed over to a collecting depot of the Federal state ("Landessammelstelle") or to a facility as determined by the competent authority.