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51–80/80
testiranje v laboratoriju
51 Prevajalska redakcija
izobraževanje
CELEX: 31998D0320
Laboratorij mora biti v takih prostorih in opremljen s tako opremo, ki ju organ, pristojen za potrjevanje semen, uradno oceni kot zadovoljiva za namen testiranja semena v okviru pooblastil.
The laboratory shall be maintained in premises and with equipment officially considered by the competent seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation.
52 Prevajalska redakcija
izobraževanje
CELEX: 32004L0018
"Priznani organi" so v skladu s pomenom iz tega člena laboratoriji za testiranje in kalibracijo ter certifikacijski in nadzorni organi, ki so usklajeni z veljavnimi evropskimi standardi.
"Recognised bodies", within the meaning of this Article, are test and calibration laboratories and certification and inspection bodies which comply with applicable European standards.
53 Prevajalska redakcija
izobraževanje
CELEX: 32000D0708
Zato je treba določbe te odločbe v zvezi z Avstralijo prilagoditi razmeram v zvezi z boleznijo v zadevni državi in zlasti umakniti zahtevo za laboratorijsko testiranje mačk, uvoženih iz Avstralije.
Therefore, the provisions of this Decision relating to Australia should be adapted to the disease situation in the country concerned, and in particular the requirement for laboratory testing for cats imported from Australia should be withdrawn.
54 Prevajalska redakcija
izobraževanje
CELEX: 32003L0085
se laboratorijsko testiranje za potrditev prisotnosti virusa slinavke in parkljevke ali virusov drugih vezikularnih bolezni izvaja v skladu s členom 71 v enem od laboratorijev iz dela A Priloge XI;
laboratory testing to confirm the presence of foot-and-mouth disease virus or other vesicular disease viruses is carried out in accordance with Article 71 by one of the laboratories listed in Part A of Annex XI;
55 Prevajalska redakcija
izobraževanje
CELEX: 31985L0511
da nacionalni laboratorij, določen v Prilogi, izvaja laboratorijsko testiranje za ugotavljanje prisotnosti slinavke in parkljevke, ki se lahko spremeni ali dopolni v skladu s postopkom iz člena 17.
laboratory testing to detect the presence of foot-and-mouth diesease are carried out by a national laboratory indicated in the Annex which may be amended or supplemented in accordance with the procedure laid down in Article 17.
56 Prevajalska redakcija
izobraževanje
CELEX: 32002L0089
v odstavku 5, v drugem pododstavku, se za tretjim stavkom doda naslednji stavek: "Ta določba se ne uporablja za izdatke, ki so rezultat naslednjih vrst zahtev, postavljenih ob sodelovanju imenovanih strokovnjakov pri inšpekcijskih pregledih ob uvozu držav članic: laboratorijsko testiranje in vzorčenje za vizualne preglede ali za laboratorijsko testiranje, ki so že pokriti s pristojbinami iz člena 13d.";
in paragraph 5, in the second subparagraph, the following sentence shall be added after the third sentence:"This provision shall not apply to expenses resulting from the following types of requests made on the occasion of the participation of the said experts in the Member States' import inspections: laboratory testing and sampling for visual inspection or for laboratory testing, and already covered by the fees referred to in Article 13d.";
57 Prevajalska redakcija
izobraževanje
CELEX: 31996L0012
Kadar so vrednosti DT90f, določene v raziskavah razgradnje fitofarmacevtskega sredstva v naravi (točka 9.1) večje od 100 dni, je treba z laboratorijskim testiranjem raziskati vpliv na neciljne talne mikroorganizme.
Where the DT90f values determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing.
58 Prevajalska redakcija
izobraževanje
CELEX: 32002D0756
Pri oceni semenskega krompirja na podlagi Direktive 2000/29/ES organ, odgovoren za izvajanje poskusov in testiranj pod odgovornostjo služb Komisije, prej označi vsak vzorec, ki se predloži v laboratorijsko testiranje.
In the case of the assessment of seed potatoes under Directive 2000/29/EC, each sample to be submitted to the laboratory tests shall have been previously coded by the body responsible for carrying out the trials and tests under the responsibility of the Commission services.
59 Prevajalska redakcija
izobraževanje
CELEX: 31998D0320
V primeru iz točke (b) sme laboratorij opravljati testiranje semena le na partijah semena, ki so bile pridelane v imenu semenarskega podjetja, v katero spada laboratorij, če ni bilo drugače dogovorjeno med tem semenarskim podjetjem, vlagateljem zahtevka za potrditev semena in organom, pristojnim za potrjevanje semena.
In the case referred to in point (b), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between the seed company to which it belongs, the applicant for certification and the competent seed certification authority.
60 Prevajalska redakcija
izobraževanje
CELEX: 32000L0075
Nacionalni laboratoriji za bolezen modrikastega jezika so odgovorni za koordinacijo standardov in diagnostičnih metod, ki jih določi vsak diagnostični laboratorij v državi članici, uporabo reagentov in testiranje cepiv.
The national laboratories for bluetongue are responsible for the coordination of the standards and diagnostic methods laid down by each diagnostic laboratory in the Member State, the use of reagents and the testing of vaccines.
61 Prevajalska redakcija
izobraževanje
CELEX: 32004D0004
med izvozno sezono je treba vzeti najmanj en vzorec na povodje ali sektor, zastopan v pošiljki, vendar je treba v vsakem primeru vzeti najmanj pet vzorcev ter jih predložiti laboratoriju v analizo v skladu s programom testiranj Skupnosti, kot je določeno v
during the export season at least one sample per basin or sector and represented in the consignment must be taken, but in any case at least five saples must be taken and submitted for laboratory analysis in accordance with the Community test scheme as laid down in
62 Prevajalska redakcija
izobraževanje
CELEX: 31992L0034
Odgovorni uradni organ izda laboratorijem pooblastilo, potem ko potrdi, da laboratoriji, njihove metode, objekti in osebje glede na testiranja, ki jih izvajajo, ustrezajo zahtevam te direktive, določenim v skladu s postopkom, iz člena 21.
The responsible official body shall accredit laboratories once it has verified that those laboratories, their methods, their establishments and their staff, meet the requirements of this Directive, to be specified according to the procedure laid down in Article 21, with regard to the testing activities they carry out.
63 Prevajalska redakcija
izobraževanje
CELEX: 32003D0017
izjavo, da je bilo seme vzorčeno in testirano v skladu s veljavnimi mednarodnimi metodami: "V skladu s pravili ISTA za oranžne ali zelene certifikate vzorčil in analiziral kakovost semena... (ime ali inicialke ISTA laboratorija za testiranje semena)",
a statement that the seed has been sampled and tested in accordance with current international methods: "Sampled and analysed according to ISTA rules for orange or green certificates by..., (name or initials of the ISTA seed testing station)",
64 Prevajalska redakcija
izobraževanje
CELEX: 32003D0466
Direktiva 93/53/EGS določa, da se vzorčenje in laboratorijsko testiranje na prisotnost bolezni s seznama I in seznama II (ki sta navedena v Prilogi A k Direktivi 91/67/EGS), izvajata s pomočjo metod, določenih v skladu s členom 15 Direktive 91/67/EGS.
Directive 93/53/EEC establishes that sampling and laboratory testing for the presence of list I and list II diseases (which are referred to in Annex A to Directive 91/67/EEC) shall be carried out using the methods established in accordance with Article 15 of Directive 91/67/EEC.
65 Prevajalska redakcija
izobraževanje
CELEX: 31996L0012
Kadar se na podlagi predlaganega načina uporabe ali na podlagi vpliva in obnašanja lahko pričakuje stalna ali ponavljajoča se izpostavljenost (ko se s pripravkom tretira več kot trikrat v sezoni, s presledki 14 dni ali manj) se za odločitev o tem, ali je potrebno nadaljnje testiranje, ki presega začetno laboratorijsko testiranje in bo odražalo predvideni način uporabe, zahteva strokovno mnenje.
Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern.
66 Prevajalska redakcija
izobraževanje
CELEX: 31995L0036
Kadar se izvajajo študije aktivnih snovi, proizvedenih v laboratoriju ali v poskusni proizvodnji, jih je treba ponoviti z aktivnimi snovmi, kakor se bodo proizvajale, razen če je mogoče utemeljiti, da je uporabljeni testni material v bistvu enak materialu za testiranje in presojo v okolju.
Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.
67 Prevajalska redakcija
izobraževanje
CELEX: 32004D0226
Treba je bilo torej spremeniti Prilogo C k Direktivi 64/432/EGS tako, da se določijo postopki testiranja, uporabni za nadzor in trgovino v okviru Skupnosti, ki čimbolj omogočajo standarde OIE, upoštevajo pa tudi nasvet Znanstvenega odbora ter nacionalnih referenčnih laboratorijev v državah članicah, ki sodelujejo v okviru mreže Evropske unije nacionalnih referenčnih laboratorijev za brucelozo.
It was therefore necessary to amend Annex C to Directive 64/432/EEC so as to lay down test procedures applicable for surveillance and trade purposes within the Community which reflect as much as possible the OIE standards but take also into account the advice of the Scientific Committee and of the national reference laboratories in the Member States cooperating within the framework of the European Union network of national reference laboratories for brucellosis.
68 Prevajalska redakcija
izobraževanje
CELEX: 32002D0836
Standardizacija preskusov in ocenjevanje novih metod za natančno ugotavljanje BSE in TSE vključuje izvajanje obvladovanja kakovosti obsežnega posmrtnega testiranja v klavnicah v sodelovanju z ustreznimi GD-ji, ad-hoc znanstvenim odborom za TSE in vodilnimi raziskovalnimi laboratoriji za TSE.
Standardisation of tests and evaluation of new methods for sensitive detection of BSE and TSE will involve the implementation of quality control of large scale post-mortem testing in abattoirs in collaboration with relevant DGs, TSE Ad-hoc Scientific Committee and leading TSE research laboratories.
69 Prevajalska redakcija
izobraževanje
CELEX: 31993L0085
Za ta raziskovanja se v primeru gomoljev odvzamejo vzorci tako semenskega krompirja kot tudi drugega krompirja, po možnosti iz uskladiščenih partij, in se pošljejo na uradno ali uradno nadzorovano laboratorijsko testiranje po metodi iz priloge I za odkrivanje in diagnosticiranje organizma.
For these surveys, in the case of tubers samples of both seed and other potatoes shall be taken, preferably from lots in store and subjected to official or officially supervised laboratory testing using the method set out in Annex I for the detection and diagnosis of the organism.
70 Prevajalska redakcija
RS
EMEA
Analize zaviralnega delovanja entekavirja proti vrsti laboratorijskih in kliničnih izolatov virusa HIV- 1 so pri različnih celičnih in testnih pogojih pokazale, da se vrednosti EC50 gibljejo v razponu od 0, 026 do > 10 µM. Pri testiranju manjših količin virusa so poročali o nižjih vrednostih EC50.
An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to > 10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
71 Prevajalska redakcija
izobraževanje
CELEX: 31993L0085
V primeru domnevnega pojava organizma odgovorni uradni organi države članice, v kateri so bili ti primeri prijavljeni, zagotovijo dokončanje uradnih ali uradno nadzorovanih laboratorijskih testiranj z uporabo metode iz priloge I in v skladu s pogoji, določenimi v točki 1 Priloge II, da se domnevni pojav organizma potrdi ali ovrže.
In cases of suspected occurrence, the responsible official bodies of the Member State in which these cases have been reported shall ensure completion of official or officially supervised laboratory testing, using the method set out in Annex I, and in accordance with the conditions specified in point 1 of Annex II, in order to confirm or refute the suspected occurrence.
72 Prevajalska redakcija
izobraževanje
CELEX: 32004R0128
Laboratorji, ki sodelujejo pri mesečnih primerjalnih testih, ki jih organizira Unione Italiana Vini (Verona, Italija) v skladu s predpisi ISO 5725 (UNI 9225) in Mednarodnim Protokolom testiranja ustreznosti za kemijske analizne laboratorije, ki jih določajo smernice AOAC, ISO in IUPAC ter ISO 43 in ILAC G13.
Laboratories participating in the monthly ring test organised by the Unione Italiana Vini (Verona, Italy) according to ISO 5725 (UNI 9225) rules and the International Protocol of Proficiency Testing for chemical analysis laboratories established by AOAC, ISO and IUPAC and ISO 43 and ILAC G13 guidelines.
73 Prevajalska redakcija
izobraževanje
CELEX: 31993L0085
Če uradno ali uradno nadzorovano laboratorijsko testiranje z uporabo metode iz Priloge I potrdi navzočnost organizma v vzorcu gomoljev, rastlin ali delov rastlin, odgovorni uradni organi države članice ob upoštevanju tehtnih znanstvenih načel, biologije organizma in posebnih pridelovalnih, tržnih in predelovalnih sistemov v tej državi članici:
If official or officially supervised laboratory testing using the method set out in Annex I confirms the presence of the organism in a sample of tubers, plants, or parts of plants, the responsible official bodies of a Member State, having regard to sound scientific principles, the biology of the organism and the particular production, marketing and processing systems in that Member State shall:
74 Prevajalska redakcija
izobraževanje
CELEX: 31996L0073
V katerem koli laboratoriju, ki je odgovoren za testiranja dvokomponentnih mešanic, za katere ne obstaja enotna metoda analize na ravni Skupnosti, določijo sestavo takih mešanic z uporabo katere koli veljavne metode, ki jim je na voljo, s tem da v poročilu o analizi navedejo dobljene rezultate ter stopnjo točnosti uporabljene metode, kolikor je ta znana.
Any laboratory responsible for the testing of binary mixtures for which there is no uniform method of analysis at Community level shall determine the composition of such mixtures by using any valid method at its disposal, indicating in the analysis report the result obtained and, in so far as this is known, the degree of accuracy of the method used.
75 Prevajalska redakcija
izobraževanje
CELEX: 31996L0073
ker lahko pri dvokomponentnih mešanicah, za katere ne obstaja enotna metoda analize na ravni Skupnosti, v laboratoriju, ki je odgovoren za testiranja, določijo sestavo takih mešanic z uporabo katere koli veljavne metode, ki jo imajo na voljo, s tem da v poročilu o analizi navedejo dobljene rezultate ter stopnjo točnosti uporabljene metode, če je ta točnost znana;
Whereas, in the case of binary mixtures for which there is no uniform method of analysis at Community level, the laboratory responsible for the test may determine the composition of such mixtures using any valid method at its disposal, indicating in the analysis report the result obtained and, in so far as this is known, the degree of accuracy of the method used;
76 Prevajalska redakcija
izobraževanje
CELEX: 31996L0012
Kadar se pri izpostavljenosti v laboratoriju ali pod kontroliranimi pogoji na polju, ugotovijo pomembni učinki ali kadar se na podlagi predlaganega načina uporabe ali na podlagi vpliva in obnašanja lahko pričakuje stalno ali ponavljajočo se izpostavljenost, se za odločitev o tem, ali je potrebno obširnejše testiranje, ki bi omogočilo natančno oceno tveganja, zahteva strokovno mnenje.
Where significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgement is required to examine whether more extensive testing is necessary to permit an accurate risk assessment.
77 Prevajalska redakcija
izobraževanje
CELEX: 32002D0542
Vsa testiranja vzorcev na aviarno influenco in atipično kokošjo kugo se opravijo v uradnih laboratorijih, ki jih določi pristojni organ, z uporabo diagnostičnih postopkov v skladu s pogoji Priloge III Direktive Sveta 92/66/EGS in Priloge III Direktive Sveta 92/40/EGS. - Dovoljena je priprava zbirnih vzorcev, pri katerih vsak zbirni vzorec obsega do največ pet posameznih ptic. - Izolate virusa je treba nemudoma predložiti nacionalnemu referenčnemu laboratoriju."
All testing of samples for avian influenza and Newcastle disease must be carried out in official laboratories designated by the competent authority, and using diagnostic procedures in accordance with the terms of Annex III of Council Directive 92/66/EEC and of Annex III of Council Directive 92/40/EEC. - Pooling of samples, up to a maximum of five samples of individual birds in one pool, is allowed. - Virus isolates must be submitted without delay to the National Reference laboratory."
78 Prevajalska redakcija
izobraževanje
CELEX: 31997L0012
Vendar pa se, z odstopanjem od prejšnjih določb, v primeru, da med rutinskim testiranjem črede ena ali več živali reagira pozitivno na tuberkulinski test in velja, da vzrok za to ni goveja tuberkuloza, sum(-i) na tuberkulozo v celoti razišče(-jo), pri čemer se zlasti izsledi in preveri čreda, ki je bila na gospodarstvu prisotna v času testiranja in, če pristojni organ meni, da je to potrebno, katera koli čreda, ki je bila na gospodarstvu prisotna pred tem, ter opravijo vse preiskave, vključno s pregledi po zakolu in laboratorijskimi preiskavami.
However, by way of derogation, if during a routine herd test one or more animals react positively to a tuberculin test, and bovine tuberculosis is not considered to be the cause of this reaction, the suspected case(s) of tuberculosis shall be fully investigated, including in particular the tracing and checking of the herd of residence at the time of the test and of any previous herd considered necessary by the competent authority and all examinations including appropriate post-mortem tests and laboratory examinations.
79 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet mora pred vpeljavo zdravila na trg zdravnikom dati izobraževalni material, ki bo vključeval naslednje informacije: • Potrebo in klinični pomen poročanja o neželenih učinkih na splošno. • Ozadje čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu, ki je povezana z zdravljenjem z zdravili za spodbujanje eritropoeze. • Seznam diagnoz ali terminov za neželene dogodke, ki so pogoj za poročanje o neželenih učinkih za zdravilo MIRCERA. • Vprašalnik, s katerim bo zbrana podrobna dokumentacija o neželenem učinku. • Ponudbo imetnika dovoljenja za promet za testiranje ali ponovno testiranje statusa protiteles v referenčnem laboratoriju. • Literaturo z informacijami o izgubi učinka in različnih vzrokoh zanjo; definicijo čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu; diagnostični postopek pri sumu na čisto aplazijo rdečih krvnih celic, povzročeno s protitelesi proti eritropoetinu; potrebo po prekinitvi zdravljenja z zdravili za spodbujanje eritropoeze zaradi navzkrižne reaktivnosti z drugimi zdravili za sprodbujanje eritropoeze na podlagi diagnoze čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu.
The MAH shall provide physicians prior to launch with an educational material that will include the following components of information: • Need and clinical importance of adverse drug reaction (ADR) reporting in general. • Background data on erythropoietin antibody-mediated pure red cell aplasia (AEAB-mediated PRCA) associated with erythropoiesis stimulating agents (ESA) treatment. • List of diagnoses or adverse events (AE) terms that trigger ADR reporting for MIRCERA. • A questionnaire to gather detailed ADR report documentation. • The MAH’ s offer of testing or re-testing antibody (AB) status in a reference laboratory. • Literature to provide information on loss of effect and its differential causes, the definition of AEAB-mediated PRCA, the diagnostic work-up of potential AEAB-mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of AEAB-mediated PRCA..
80 Prevod
promet
da glede laboratorijskih testov v zvezi z izdelki iz Dodatka I.A. na zahtevo ene pogodbenice druga pogodbenica sodeluje v periodičnem primerjalnem programu testiranja pri posameznih testih, ki jih organizira referenčni laboratorij pogodbenice, ki izda zahtevo.
that, for laboratory tests related to commodities of Appendix I.A., on request of one Party, the other Party shall participate in the periodical inter-comparative test programme for specific tests organised by the reference laboratory of the requesting Party.
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testiranje v laboratoriju