natgillin/translations-raw huggingface dataset:
In areas within workplaces, where the radon concentration (as an annual average), continues to exceed the national reference level, despite the action taken in accordance with the principle of optimisation as set out in Chapter III, Member States shall require this situation to be notified in accordance with Article 25(2) and Article 35(2) shall apply.
Kadar koncentracija radona (kot letno povprečje) na območjih znotraj delovnih mest ostaja nad nacionalnim referenčnim nivojem navzlic ukrepom, sprejetim v skladu z načelom optimizacije iz poglavja III, države članice zahtevajo, da se ta primer priglasi v skladu s členom 25(2) in uporablja se člen 35(2).
MEDICAL EXPOSURES
IZPOSTAVLJENOSTI V ZDRAVSTVU
Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health of an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionising radiation.
Zadostna čista korist zaradi izpostavljenosti sevanju v zdravstvu, ob upoštevanju njene celotne potencialne diagnostične ali terapevtske koristi, vključno z neposredno koristjo za zdravje ali dobre počutje posameznika in koristjo za družbo, mora odtehtati škodo za zdravje posameznika, ki jo lahko povzroči izpostavljenost sevanju, pri čemer se upoštevajo učinkovitost, koristi in tveganja pri uporabi alternativnih razpoložljivih tehnik, ki imajo isti cilj, a ne vključujejo izpostavljenosti ionizirajočemu sevanju ali pa je ta manjša.
Member States shall ensure that the principle defined in paragraph 1 is applied and in particular that:
Države članice zagotovijo, da se uporablja načelo iz odstavka 1 in zlasti da:
new types of practices involving medical exposure are justified in advance before being generally adopted;
se nove vrste dejavnosti, ki vključujejo izpostavljenost v zdravstvu, upravičijo, še preden se začnejo splošno izvajati;
all individual medical exposures are justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved.
se vsaka posamezna izpostavljenost v zdravstvu vnaprej upraviči, ob upoštevanju specifičnih namenov izpostavljenosti sevanju in značilnosti izpostavljenega posameznika;
if a type of practice involving medical exposure is not justified in general, a specific individual exposure of this type can be justified, where appropriate, in special circumstances, to be evaluated on a case-by-case basis and documented.
se, kadar vrsta dejavnosti, ki vključuje izpostavljenost v zdravstvu, načeloma ni upravičena, lahko specifična posamezna izpostavljenost te vrste upraviči v posebnih okoliščinah, kjer je to ustrezno, vendar jo je treba za vsak primer posebej oceniti in dokumentirati;
the referrer and the practitioner, as specified by Member States, seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.
kadar je to praktično, si napotni zdravnik in izvajalec, kot določijo države članice, prizadevata za pridobitev poprejšnjih diagnostičnih informacij ali zdravstvenih kartotek, pomembnih za načrtovano izpostavljenost in preučitev teh podatkov, da bi se izognila nepotrebni izpostavljenosti;
medical exposure for medical or biomedical research are examined by an ethics committee, set up in accordance with national procedures and/or by the competent authority;
izpostavljenost v zdravstvu za medicinske ali biomedicinske raziskave preuči odbor za etična vprašanja, ki je ustanovljen v skladu z nacionalnimi postopki in/ali ga ustanovi pristojni organ;
specific justification for medical radiological procedures to be performed as part of a health screening programme are carried out by the competent authority in conjunction with appropriate medical scientific societies or relevant bodies.
posebno upravičenost medicinskih radioloških posegov, ki jih je treba izvajati kot del programa presejanja, potrdi pristojni organ, skupaj z ustreznimi medicinsko-znanstvenimi združenji ali ustrezni organi;
the exposure of carers and comforters show a sufficient net benefit, taking into account the direct health benefits to a patient, the possible benefits to the carer / comforter and the detriment that the exposure might cause.
izpostavljenost posameznikov, ki pomagajo pri negi in oskrbi pacientov, mora imeti zadostno čisto korist, ob upoštevanju neposrednih koristi za zdravje bolnika, morebitnih koristi za posameznike, ki pomagajo pri negi in oskrbi pacientov, in škode, ki jo lahko povzroči izpostavljenost;
any medical radiological procedure on an asymptomatic individual, to be performed for the early detection of disease, is part of a health screening programme, or requires specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and the competent authority.
vsak medicinski radiološki poseg, izveden na asimptomatskem posamezniku za namene zgodnje diagnostike, je del programa presejanja ali zahteva posebno dokumentirano upravičenost za zadevnega posameznika, ki jo potrdi izvajalec po posvetovanju z napotnim zdravnikom in ob upoštevanju smernic ustreznih medicinsko-znanstvenih združenj in pristojnega organa.
Special attention shall be given to the provision of information to the individual subject to medical exposure, as required by point (d) of Article 57(1).
Posebna pozornost se nameni zagotavljanju informacij izpostavljenemu posamezniku v zdravstvu, kot je zahtevano v točki (d) člena 57(1).
Member States shall ensure that all doses due to medical exposure for radiodiagnostic, interventional radiology, planning, guiding and verification purposes are kept as low as reasonably achievable consistent with obtaining the required medical information, taking into account economic and societal factors.
Države članice zagotovijo, da so vse doze, ki so posledica izpostavljenosti v zdravstvu za namene radiodiagnostike, interventne radiologije, načrtovanja, usmerjanja zdravljenja in preverjanja, tako nizke, kolikor je to razumno mogoče doseči, in skladne s pridobivanjem zahtevanih zdravstvenih informacij, pri čemer se upoštevajo ekonomski in družbeni dejavniki.
For all medical exposure of patients for radiotherapeutic purposes, exposures of target volumes shall be individually planned and their delivery appropriately verified taking into account that doses to non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure.
Za vsako izpostavljenost bolnikov sevanju v zdravstvu za radioterapevtske namene se izpostavljenost ciljnih prostornin posamezno načrtuje, njeno doziranje pa ustrezno preverjeno, ob upoštevanju, da so doze neciljnih prostornin in tkiv tako nizke, kolikor je to razumno mogoče doseči, in skladne z želenim radioterapevtskim namenom izpostavljenosti.
Member States shall ensure the establishment, regular review and use of diagnostic reference levels for radiodiagnostic examinations, having regard to the recommended European diagnostic reference levels where available, and where appropriate, for interventional radiology procedures, and the availability of guidance for this purpose.
Države članice zagotovijo določitev, redno pregledovanje in uporabo diagnostičnih referenčnih nivojev za radiodiagnostične preiskave, pri čemer upoštevajo priporočljive evropske diagnostične referenčne nivoje, kadar so ti na voljo, in za posege interventne radiologije, kadar je to ustrezno, ter razpoložljivost navodil v ta namen.
Member States shall ensure that for each medical or biomedical research project involving medical exposure:
Države članice za vsak projekt medicinskih in biomedicinskih raziskav, ki vključuje izpostavljenost v zdravstvu, zagotovijo, da:
the individuals concerned participate voluntarily;
zadevni posamezniki sodelujejo prostovoljno;
these individuals are informed about the risks of exposure;
so ti posamezniki obveščeni o tveganjih zaradi izpostavljenosti;
a dose constraint is established for individuals for whom no direct medical benefit is expected from exposure;
je določena dozna ograda za posameznike, za katere je pričakovati, da ne bodo imeli neposredne medicinske koristi zaradi izpostavljenosti;
in the case of patients who voluntarily accept to undergo an experimental medical practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the dose levels concerned shall be considered on an individual basis by the practitioner and/or referrer prior to the exposure taking place.
v primeru bolnikov, ki prostovoljno privolijo v poskusni zdravstveni poseg in za katere je pričakovati, da bodo imeli diagnostično ali terapevtsko korist zaradi tega posega, morata izvajalec in/ali napotni zdravnik določiti zadevne nivoje doz za vsak primer posebej in pred izpostavitvijo.
Member States shall ensure that the optimisation includes the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcomes, the practical aspects of medical radiological procedures, quality assurance, and the assessment and evaluation of patient doses or the verification of administered activities, taking into account economic and societal factors.
Države članice zagotovijo, da optimizacija vključuje izbiro opreme, stalno pridobivanje zadovoljivih diagnostičnih informacij ali izidov zdravljenja, praktične vidike medicinskih radioloških posegov, zagotavljanje kakovosti ter oceno in ovrednotenje doz za bolnika ali preverjanje doziranja aktivnosti, pri čemer se upoštevajo ekonomski in družbeni dejavniki.
dose constraints are established for the exposure of carers and comforters, where appropriate;
določijo dozne ograde za izpostavljenost posameznikov, ki pomagajo pri negi in oskrbi pacientov, kadar je to ustrezno;
appropriate guidance is established for the exposure of carers and comforters.
oblikujejo ustrezna navodila za izpostavljenost posameznikov, ki pomagajo pri negi in oskrbi pacientov.
Member States shall ensure that in the case of a patient undergoing treatment or diagnosis with radionuclides, the practitioner or the undertaking, as specified by Member States, provides the patient or their representative with information on the risks of ionising radiation and appropriate instructions with a view to restricting doses to persons in contact with the patient as far as reasonably achievable.
Države članice zagotovijo, da izvajalec ali podjetje, kot določijo države članice, pri zdravljenju ali diagnosticiranju bolnika z radionuklidi zagotovi bolniku ali njegovemu zastopniku informacije o tveganjih zaradi ionizirajočega sevanja in ustrezna navodila, da se za osebe v stiku z bolnikom omejijo doze, kolikor je to razumno mogoče doseči.
For therapeutic procedures these shall be written instructions.
Pri terapevtskih posegih se zagotovijo pisna navodila.
These instructions shall be handed out before leaving the hospital or clinic or a similar institution.
Ta navodila se izročijo pred odhodom iz bolnišnice, klinike ali podobne ustanove.
any medical exposure takes place under the clinical responsibility of a practitioner;
je izvajalec klinično odgovoren za vsako izpostavljenost v zdravstvu;
the practitioner, the medical physics expert and those entitled to carry out practical aspects of medical radiological procedures are involved, as specified by Member States, in the optimisation process;
izvajalec, izvedenec medicinske fizike in tisti, ki so pooblaščeni za opravljanje praktičnih vidikov radioloških posegov, sodelujejo v procesu optimizacije, kot določijo države članice;
the referrer and the practitioner are involved, as specified by Member States, in the justification process of individual medical exposures;
napotni zdravnik in izvajalec sodelujeta v procesu upravičenja posameznih izpostavljenosti v zdravstvu, kot določijo države članice;
wherever practicable and prior to the exposure taking place, the practitioner or the referrer, as specified by Member States, ensures that the patient or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure.
kadar je to praktično in pred samo izpostavljenostjo, izvajalec ali napotni zdravnik, kot določijo države članice, zagotovi, da bolnik ali njegov zastopnik prejme ustrezne informacije o koristih in tveganjih, povezanih z dozo sevanja zaradi izpostavljenosti v zdravstvu.
Similar information as well as relevant guidance shall be given to carers and comforters, in accordance with point (b) of Article 56(5).
Podobne informacije in ustrezna navodila v skladu s točko (b) člena 56(5) se zagotovijo posameznikom ki pomagajo pri negi in oskrbi pacientov.
Practical aspects of medical radiological procedures may be delegated by the undertaking or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognised field of specialisation.
Praktične vidike medicinskih radioloških posegov lahko podjetje ali izvajalec, kot je ustrezno, prenese na enega ali več posameznikov, ki lahko opravljajo naloge v zvezi s tem na priznanem področju specializacije.
Procedures
Posegi
written protocols for every type of standard medical radiological procedure are established for each equipment for relevant categories of patients;
se določijo pisni protokoli za vsako vrsto standardnih medicinskih radioloških posegov, natančneje za vsako opremo in za ustrezne kategorije bolnikov;
information relating to patient exposure forms part of the report of the medical radiological procedure;
so informacije o izpostavljenosti bolnika del poročila o medicinskem radiološkem posegu;
referral guidelines for medical imaging, taking into account the radiation doses, are available to the referrers;
so navodila za napotitev na medicinsko slikanje, ob upoštevanju doz sevanja, na razpolago napotnim zdravnikom;
in medical radiological practices, a medical physics expert is appropriately involved, the level of involvement being commensurate with the radiological risk posed by the practice.
izvedenec medicinske fizike ustrezno sodeluje pri medicinskih radioloških posegih, pri čemer je njegovo sodelovanje sorazmerno z radiološkim tveganjem, povezanim z dejavnostjo.
In particular:
Izvedenec medicinske fizike zlasti:
in radiotherapeutic practices other than standardised therapeutic nuclear medicine practices, a medical physics expert shall be closely involved;
tesno sodeluje pri radioterapevtskih dejavnostih, razen standardnih nuklearnomedicinskih terapevtskih dejavnostih;
in standardised therapeutical nuclear medicine practices as well as in radiodiagnostic and interventional radiology practices, involving high doses as referred to in point (c) of Article 61(1), a medical physics expert shall be involved;
sodeluje pri standardnih nuklearnomedicinskih terapevtskih dejavnostih ter pri radiodiagnostičnih in interventnih radioloških dejavnostih, ki vključujejo visoke doze iz točke (c) člena 61(1);
for other medical radiological practices not covered by points (a) and (b), a medical physics expert shall be involved, as appropriate, for consultation and advice on matters relating to radiation protection concerning medical exposure.
po potrebi sodeluje pri drugih medicinskih radioloških posegih, izvzetih iz točk (a) in (b), za namene posvetovanja in svetovanja o vprašanjih, povezanih z varstvom pred sevanjem pri izpostavljenosti v zdravstvu;
clinical audits are carried out in accordance with national procedures;
se klinične presoje izvajajo v skladu z nacionalnimi postopki;
appropriate local reviews are undertaken whenever diagnostic reference levels are consistently exceeded and that appropriate corrective action is taken without undue delay.
se takrat, ko so diagnostični referenčni nivoji stalno preseženi, opravijo ustrezni lokalni pregledi in se brez nepotrebnega zavlačevanja sprejmejo ustrezni korektivni ukrepi.
Training and recognition
Usposabljanje in priznavanje
Member States shall ensure that training and recognition requirements, as laid down in Articles 79, 14 and 18, are met for the practitioner, the medical physics expert and the individuals referred to in Article 57(2).
Države članice zagotovijo, da so zahteve glede usposabljanja in priznavanja, določene v členih 79, 14 in 18, izpolnjene za izvajalca, izvedenca medicinske fizike in posameznike iz člena 57(2).
all medical radiological equipment in use is kept under strict surveillance regarding radiation protection;
je vsa medicinska radiološka oprema, ki je v uporabi, pod strogim nadzorom z vidika varstva pred sevanjem;
an up-to-date inventory of medical radiological equipment for each medical radiological installation is available to the competent authority;
ima pristojni organ na razpolago najnovejši popis medicinske radiološke opreme za vsak medicinski radiološki objekt;
appropriate quality assurance programmes and assessment of dose or verification of administered activity are implemented by the undertaking; and
podjetje izvaja ustrezne programe zagotavljanja kakovosti in oceno doz ali preverjanje uporabljenega radioaktivnega odmerka ter
acceptance testing is carried out before the first use of the equipment for clinical purposes, and performance testing is carried out thereafter on a regular basis, and after any maintenance procedure liable to affect the performance.
je opravljen prevzemni preskus pred prvo uporabo opreme v klinične namene, nato pa redno preverjanje delovanja opreme, tudi po vsakem vzdrževanju, ki bi lahko vplivalo na delovanje opreme.
Member States shall ensure that the competent authority takes steps to ensure that the necessary measures are taken by the undertaking to improve inadequate or defective performance of medical radiological equipment in use.
Države članice poskrbijo, da pristojni organ zagotovi, da podjetje sprejme potrebne ukrepe za zboljšanje neustreznega ali pomanjkljivega delovanja medicinske radiološke opreme v uporabi.
They shall also adopt specific criteria for the acceptability of equipment in order to indicate when appropriate corrective action is necessary, including taking the equipment out of service.
Sprejmejo tudi specifična merila za sprejemljivost opreme, da se lahko ugotovi, kdaj so potrebni ustrezni korektivni ukrepi, vključno z izločitvijo opreme iz uporabe.
the use of fluoroscopy equipment without a device to automatically control the dose rate, or without an image intensifier or equivalent device, is prohibited.
je prepovedana uporaba opreme za fluoroskopijo, ki nima naprave za samodejno kontrolo hitrosti doz ali ojačevalnika slike ali enakovredne naprave;
equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV has a device to verify key treatment parameters.
ima oprema, ki se uporablja za teleterapijo z nominalno energijo snopa višjo od 1 MeV, napravo za preverjanje ključnih parametrov zdravljenja.
Equipment installed prior to 6 February 2018 may be exempted from this requirement.
Oprema, ki je bila nameščena pred 6. februar 2018, se lahko izvzame iz te zahteve;
any equipment used for interventional radiology has a device or a feature informing the practitioner and those carrying out practical aspects of the medical procedures of quantity of radiation produced by the equipment during the procedure.
ima vsa oprema, ki se uporablja za interventno radiologijo, napravo ali element, ki izvajalca ali osebe, ki izvajajo praktične vidike medicinskih posegov, obvešča o količini sevanja, ki ga oprema oddaja med posegom.
any equipment used for interventional radiology and computed tomography and any new equipment used for planning, guiding and verification purposes has a device or a feature informing the practitioner, at the end of the procedure, of relevant parameters for assessing the patient dose.
ima vsa oprema, ki se uporablja za interventno radiologijo in računalniško tomografijo, in vsaka nova oprema, ki se uporablja za namene načrtovanja, usmerjanja zdravljenja in preverjanja, napravo ali element, ki izvajalca ob koncu posega obvešča o pomembnih parametrih za oceno pacientove doze;
equipment used for interventional radiology and computed tomography has the capacity to transfer the information required under 3(d) to the record of the examination.
je oprema, ki se uporablja za interventno radiologijo in računalniško tomografijo, takšna, da omogoča prenos informacij, zahtevanih pod točko 3(d), v poročilo o pregledu.
without prejudice to points (c), (d) and (e) of paragraph 3, new medical radiodiagnostic equipment producing ionising radiation has a device, or an equivalent means, informing the practitioner of relevant parameters for assessing the patient dose.
brez poseganja v točke (c), (d) in (e) odstavka 3 ima nova medicinska radiodiagnostična oprema, ki oddaja ionizirajoče sevanje, napravo ali enakovreden element, ki izvajalca obvešča o pomembnih parametrih za oceno doze za bolnika.
Where appropriate, the equipment shall have the capacity to transfer this information to the record of the examination.
Kadar je to ustrezno, je oprema takšna, da omogoča prenos teh informacij v evidenco o pregledu.
Special practices
Posebni posegi
Member States shall ensure that appropriate medical radiological equipment, practical techniques and ancillary equipment is used in medical exposure:
Države članice zagotovijo uporabo ustrezne medicinske radiološke opreme, praktičnih tehnik in pomožne opreme pri izpostavljenosti v zdravstvu:
of children;
otrok;
as part of a health screening programme;
kot dela programa presejanja;
involving high doses to the patient, which may be the case in interventional radiology, nuclear medicine, computed tomography or radiotherapy.
pri kateri bolnik prejme visoke doze sevanja, kar se lahko dogodi pri interventni radiologiji, nuklearni medicini, računalniški tomografiji ali radioterapiji.
Special attention shall be given to quality assurance programmes and the assessment of dose or verification of administered activity for these practices.
Posebna pozornost se nameni programom zagotavljanja kakovosti in oceni doz ali preverjanju uporabljenega radioaktivnega odmerka za te posege.
Member States shall ensure that practitioners and those individuals referred to in Article 57(2) who perform the exposures referred to in paragraph 1 obtain appropriate training on these medical radiological practices as required by Article 18.
Države članice zagotovijo, da so izvajalci in tisti posamezniki iz člena 57(2), ki izvajajo dejavnosti, ki vključujejo izpostavljenosti iz odstavka 1, deležni ustreznega usposabljanja o teh medicinskih radioloških posegih, kot zahteva člen 18.
Special protection during pregnancy and breastfeeding
Posebno varstvo med nosečnostjo in dojenjem
Member States shall ensure that the referrer or the practitioner, as appropriate, inquire, as specified by Member States, whether the individual subject to medical exposure is pregnant or breastfeeding, unless it can be ruled out for obvious reasons or is not relevant for the radiological procedure.
Države članice zagotovijo, da se napotni zdravnik ali izvajalec, kakor je ustrezno, pozanimata, kot določijo države članice, ali je posameznica, ki bo deležna izpostavljenosti v zdravstvu, noseča ali doji, razen če je to mogoče izključiti iz očitnih razlogov ali to ni pomembno za radiološki poseg.
If pregnancy cannot be ruled out and depending on the medical radiological procedure, in particular if abdominal and pelvic regions are involved, special attention shall be given to the justification, particularly the urgency, and to the optimisation, taking into account both the expectant individual and the unborn child.
Če nosečnosti ni mogoče izključiti, je odvisno od medicinskega radiološkega posega, zlasti če gre za obsevanje abdominalnega ali medeničnega predela, posebno pozornost treba nameniti upravičenosti, zlasti nujnosti, in optimizaciji, ob upoštevanju izpostavljenosti tako nosečnice kot nerojenega otroka.