Liuksemburgas – Saugos konsultacinės paslaugos – SAMIRA study on criteria for acceptability of medical radiological equipment

Liuksemburgas – Saugos konsultacinės paslaugos – SAMIRA study on criteria for acceptability of medical radiological equipment

I dalis: Perkančioji organizacija

I.1) Pavadinimas ir adresai:

Oficialus pavadinimas: European Commission, DG ENER - Energy
Adresas: rue Mercier 2
Miestas: LUXEMBOURG
Pašto kodas: L-2144
Šalis: Liuksemburgas
Asmuo ryšiams:
El-paštas: ENER-RADPROT@ec.europa.eu
Interneto adresas (-ai):
Pagrindinis adresas: https://ec.europa.eu/energy/

II dalis: Objektas

II.1.1) Pavadinimas:

SAMIRA study on criteria for acceptability of medical radiological equipment
Nuorodos numeris: EC-ENER/LUX/2024/OP/0020

II.1.2) Pagrindinis BVPŽ kodas:

79417000 Saugos konsultacinės paslaugos ;

II.1.3) Sutarties tipas:

Kita

II.1.4) Trumpas aprašymas:

The purpose of this study is to review and revise publication Radiation Protection 162 (RP 162), in view of updating and upgrading the criteria for acceptability of medical radiological equipment contained therein. The revised guidance will define essential parameters relevant to the assessment of the performance of radiological medical equipment and will set up up-to-date criteria for acceptability of this equipment, considering developments in technology, standards and requirements that occurred since the publication of RP 162. The contractor must propose criteria for acceptability that are achievable throughout the EU Member States and provide advice on their implementation and verification in practice. The revised document will rely, to the extent possible, on the methodology for defining and applying criteria for acceptability of equipment established in section 1 of RP 162. Any change of the proposed methodology shall be substantiated and approved by DG ENER before progressing with Task 2 of the study as described in the tender specifications. The contractor will develop criteria for acceptability of equipment that came on the market after 2010 or was too new to be addressed in RP 162. This should include radiological and nuclear medicine imaging systems used for health screening, diagnostic and interventional procedures, and treatment planning and guidance. The contractor will make an effort to define, to the extent possible, criteria for modern and advanced computed tomography (CT) systems, including cone beam CT, advanced image acquisition and reconstruction, and multidetector and dual-energy CT, as well as for other modern imaging equipment, including digital breast tomosynthesis, hybrid imaging systems (SPECT-CT, PET-CT, etc.), and bedside and mobile radiological imaging equipment. Similarly, the work should cover modern radiotherapy equipment, including stereotactic radiosurgery (SRS), stereotactic body radiation therapy (SBRT), and proton radiotherapy. The updated guidance should further include advice on how to deal with situations where criteria for acceptability could not be defined, or where there is rapid innovation in equipment. Special emphasis shall be put on equipment used for paediatric radiology since safety and performance standards may be different from those accepted for adults. Similarly, the revised guidance should deal, where practical, with the implications for equipment used in health screening, in high-dose interventional procedures, and other special issues noted in the BSS Directive. For the essential parameters to be investigated, the guidance will delineate methods relying on non-invasive measurements performed at regular intervals by the operating personnel using test equipment where necessary. The guidance should benefit the holder of the radiological installations by helping them set up protocols for quality control to demonstrate that the equipment installed is fit for use and indicate the need for remedial action. In addition, it will support bodies responsible for technical surveillance and relevant public authorities in verifying the compliance of equipment with regulations on technical safety. Special attention should be paid to the fact that all references describing test procedures should be either freely available to the public or test procedures shall be described in detail in order to enable application of the results by end users.

II.2) Aprašymas:

II.2.1) Kitas (-i) šio pirkimo BVPŽ kodas (-ai):

79417000 Saugos konsultacinės paslaugos