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1–50/68
program preskušanja
1 Končna redakcija
DRUGO
Priglašeni organ lahko zahteva nadaljnje vzorce, če so potrebni za izvajanje programa preskušanja.
The notified body may request further specimens if needed for carrying out the test programme.
2 Končna redakcija
DRUGO
Na začetku leta 2001 je satelitski radionavigacijski program Galileo, v nadaljnjem besedilu "program Galileo", vstopil v svojo razvojno fazo, namenjeno preverjanju in preskušanju predpostavk iz opredelitvene faze, zlasti glede različnih komponent (sestavnih delov) zgradbe sistema.
At the beginning of 2001, the management of the Galileo satellite radio-navigation programme, hereinafter referred to as the "Galileo programme", entered its development phase aimed at verifying and testing the assumptions made during the definition phase, in particular with regard to the various components of the architecture of the system.
3 Pravna redakcija
finance
CELEX: 32003L0063
zato vlagatelj utemelji izvedeni program preskušanja.
therefore the testing program carried out shall be justified by the applicant.
4 Pravna redakcija
DRUGO
statistično ovrednotenje rezultatov, če tako zahteva program preskušanja.
a statistical evaluation of the results, when this is called for by the test programme.
5 Pravna redakcija
DRUGO
statistične analize rezultatov, če to zahteva program preskušanja ter razhajanja v podatkih;
a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
6 Pravna redakcija
delo in sociala
CELEX: 32003R2151
Storitve preskušanja in vzdrževanja programske opreme
Software testing and maintenance services
7 Pravna redakcija
finance
CELEX: 32003L0063
Pri pripravi programa preskušanja se upošteva naslednje:
In establishing the testing program, the following shall be taken into consideration:
8 Pravna redakcija
DRUGO
po potrebi, preskušanja vzorcev, odvzetih v proizvodnem obratu skladno s predpisanim programom preskušanja;
possibly, testing of samples taken at the factory in accordance with a prescribed test plan;
9 Pravna redakcija
DRUGO
dodatnega preskušanja vzorcev, ki jih v proizvodnem obratu skladno s predpisanim programom preskušanja odvzame proizvajalec;
further testing of samples taken at the factory by the manufacturer in accordance with a prescribed test plan;
10 Pravna redakcija
DRUGO
Kartica preskuševališča prepozna telo in omogoča preskušanje, umerjanje in programiranje tahografa.
The test station card identifies the body and allows for testing, calibration and programming of the recording equipment;
11 Pravna redakcija
DRUGO
preskušanje vzorcev, ki jih v skladu s predpisanim programom preskušanja v proizvodnem obratu odvzame proizvajalec ali odobreni organ;
testing of samples taken at the factory in accordance with a prescribed test plan by the manufacturer or an approved body;
12 Pravna redakcija
DRUGO
V prihodnje bodo lahko v programe preskušanja skladnosti predložena tudi vozila, ki uporabljajo posebne tehnologije za majhno porabo goriva.
In the future, vehicles with special fuel efficient technologies may be offered which could be submitted to complementary testing programmes.
13 Pravna redakcija
DRUGO
Program za zagotavljanje kakovosti mora izvajati oseba ali osebe, ki jih imenuje odgovorna oseba in morajo biti odgovorni osebi tudi neposredno odgovorne ter so seznanjene s postopki preskušanja.
The quality assurance programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.
14 Pravna redakcija
finance
CELEX: 32002R0876
Na začetku leta 2001 je satelitski radionavigacijski program Galileo, v nadaljnjem besedilu "program Galileo", vstopil v svojo razvojno fazo, namenjeno preverjanju in preskušanju predpostavk iz opredelitvene faze, zlasti glede različnih komponent ( sestavnih delov ) zgradbe sistema.
At the beginning of 2001, the management of the Galileo satellite radio-navigation programme, hereinafter referred to as the 'Galileo programme', entered its development phase aimed at verifying and testing the assumptions made during the definition phase, in particular with regard to the various components of the architecture of the system.
15 Pravna redakcija
promet
CELEX: 22001A0626(01)
"specifikacije" so zahteve glede energetske učinkovitosti in zmogljivosti, vključno z metodami preskušanja, naštete v Prilogi C, ki jih uporabljajo upravljalna organa in udeleženci programa pri določanju, ali se energetsko učinkovitim izdelkom lahko prizna skupni logotip.
'Specifications' are the energy-efficiency and performance requirements, including testing methods listed in Annex C, used by Management Entities and Program Participants to determine qualification of energy-efficient products for the Common Logo.
16 Pravna redakcija
DRUGO
Z Odločbo Komisije 98/64/ES z dne 9. decembra 1997 o finančnem prispevku Skupnosti za izboljšanje programa nadzora nad slinavko in parkljevko v Turčiji fn je bilo v okviru delovnega načrta sklenjeno, da bo Evropska komisija uredila preskušanje cepiva proti slinavki in parkljevki, izdelanega v Turčiji.
By Commission Decision 98/64/EC of 9 December 1997 on a Community financial contribution for improving the foot-and-mouth disease control programme in Turkey (7), it was agreed as a part of a work plan that the European Commission would make arrangements for testing of foot-and-mouth disease vaccine produced in Turkey.
17 Pravna redakcija
promet
CELEX: 32003D0398
Sprejeti program za prenos veterinarskega in fitosanitarnega pravnega reda; okrepiti upravne, znanstvene in tehnične strukture, ki omogočajo smotrno in učinkovito izvajanje pravnega redu o varstvu rastlin, zlasti laboratorijsko preskušanje; okrepiti inšpekcijo domače pridelave in uvoženih rastlin in rastlinskih proizvodov, prav tako v obratih za predelavo hrane.
Adopt a programme for transposition of the veterinary and phytosanitary acquis; strengthen the administrative, scientific and technical structures enabling the efficient and effective implementation of the acquis on plant protection, in particular laboratory testing; strengthen inspection arrangements of both domestic production and imports of plants and plant products, as well as in food-processing establishments.
18 Pravna redakcija
DRUGO
Po potrebi ta navodila vključujejo servisne priročnike, tehnična navodila, napotke za diagnozo (npr. najmanjše in največje teoretične vrednosti za merjenje), sheme električne povezave, identifikacijsko številko za kalibracijo programske opreme, navodila za posamezne in posebne primere, informacije o orodju in opremi, pojasnila o zapisovanju informacij in dvosmernem nadzoru ter informacije o preskušanju.
Where necessary, such information shall include service handbooks, technical manuals, diagnosis information (e.g. minimum and maximum theoretical values for measurements), wiring diagrams, the software calibration identification number applicable to a vehicle type, instructions for individual and special cases, information provided concerning tools and equipment, data record information and two-directional monitoring and test data.
19 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
zato vlagatelj utemelji izveden program preskušanja.
therefore the testing programme carried out shall be justified by the applicant.
20 Prevajalska redakcija
izobraževanje
CELEX: 32001R0213
Drugi pododstavek ne velja za laboratorije, ki so bili v zadevnem letu vključeni v program preskušanja strokovnosti.
The second subparagraph shall not apply to laboratories that have participated in a proficiency testing scheme during the year.
21 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Pri vzpostavljanju programa preskušanja se upošteva naslednje:
In establishing the testing programme, the following shall be taken into consideration:
22 Prevajalska redakcija
izobraževanje
CELEX: 31989L0106
po potrebi, preskušanja vzorcev, odvzetih v proizvodnem obratu skladno s predpisanim programom preskušanja;
possibly, testing of samples taken at the faccory in accordance with a prescribed test plan;
23 Prevajalska redakcija
izobraževanje
CELEX: 31993L0099
zahtevajo uporabo programov za medlaboratorijska primerjalna preskušanja, če je to primerno.
require the use of proficiency testing schemes as far as appropriate.
24 Prevajalska redakcija
RS
EMEA
V Evropski uniji ne poteka nobeno klinično preskušanje kakor tudi ne program sočutne uporabe zdravila Alpheon.
There are no ongoing clinical trials or compassionate use programmes with Alpheon in the European Union.
25 Prevajalska redakcija
RS
EMEA
Deferipron so preizkusili na 247 bolnikih v dveh preskušanjih III faze in v t. i. " compassionate use " programu.
6 Deferiprone has been investigated in 247 patients in two phase III trials and a compassionate use programme.
26 Prevajalska redakcija
RS
EMEA
To poglavje navaja informacije, ki temeljijo na vseh neželenih učinkih iz kliničnih preskušanj, postmarekinških študij in spontanih poročil. V programu kliničnih preskušanj so se pri približno
This section provides information based on all adverse reactions from clinical trials, post-marketing studies or spontaneous reports.
27 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe cepiva Aflunov?
What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
28 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Advexin?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Advexin?
29 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Evoltra?
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Evoltra?
30 Prevajalska redakcija
RS
EMEA
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih/ programih sočutne uporabe zdravila Alpheon?
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Alpheon?
31 Prevajalska redakcija
RS
EMEA
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila CIMZIA?
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using CIMZIA?
32 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila NutropinAq?
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using NutropinAq?
33 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Orplatna?
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna?
34 Prevajalska redakcija
RS
EMEA
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Diractin?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin?
35 Prevajalska redakcija
RS
EMEA
Podatki o izpostavljenosti večjemu odmerku, kot je priporočen, so omejeni na klinično preskušanje in poseben program zdravljenja.
Two patients had nausea after 2.7 mg IM dose, and in one of these patients, the event was also accompanied by weakness, dizziness and headache.
36 Prevajalska redakcija
izobraževanje
CELEX: 32001D0048
vključitev in terensko preskušanje internetno podprtih programskih orodij na področju upravljanja lokalizacije vsebin in njihovega kroženja;
integration and field testing of Internet-based software tools in the areas of content localisation management and workflow;
37 Prevajalska redakcija
izobraževanje
CELEX: 31998D0457
ker je bila izbrana izvedba SBI predmet medlaboratorijskega ("round robin") programa preskušanja, ki je zajel obsežen niz gradbenih proizvodov;
Whereas the preferred SBI configuration has been subject to an inter-laboratory ('round robin`) testing programme covering a wide range of construction materials;
38 Prevajalska redakcija
RS
EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Lacosamide Pain UCB Pharma?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?
39 Prevajalska redakcija
RS
EMEA
Varnost cepiva Optaflu so ocenili v šestih randomiziranih, aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.
The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program.
40 Prevajalska redakcija
RS
EMEA
Celotna ugotovljena incidenca malignih bolezni v programu kliničnega preskušanja zdravila Xolair je bila primerljiva s tisto v splošni populaciji.
The overall observed incidence rate of malignancy in the Xolair clinical trial programme was comparable to that reported in the general population.
41 Prevajalska redakcija
RS
EMEA
Družba je obvestila CHMP, da trenutno v Evropi klinična preskušanja ali programi sočutne uporabe zdravila NutropinAq za to indikacijo ne potekajo.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
42 Prevajalska redakcija
RS
EMEA
Družba je obvestila CHMP, da umik nima posledic za bolnike, ki so vključeni v klinična preskušanja ali programe sočutne uporabe za zdravilo Evoltra.
The company informed the CHMP that this withdrawal has no consequences for patients enrolled in clinical trials or compassionate use programmes with Evoltra.
43 Prevajalska redakcija
RS
EMEA
Družba odbora CHMP ni obvestila, ali ima umik kakršne koli posledice za bolnike v kliničnih preskušanjih ali programih sočutne uporabe zdravila Advexin.
The company did not inform the CHMP whether there were any consequences of the withdrawal for patients in clinical trials or compassionate use programmes with Advexin.
44 Prevajalska redakcija
izobraževanje
CELEX: 31999D0382
Sredstva, dodeljena za podporo oblikovanja, razvoja in preskušanja projektov za jezikovne kompetence, ne smejo biti manjša od 5 % letnega proračuna za program.
The funds allocated in support of devising, developing and testing Language Competence projects may not be less than 5 % of the annual budget for the programme.
45 Prevajalska redakcija
izobraževanje
CELEX: 31999D0382
Sredstva, dodeljena za podporo oblikovanju, razvoju in preskušanju nadnacionalnih pilotnih projektov, ne smejo biti manjša od 36 % letnega proračuna za program.
The funds allocated in support of devising, developing and testing transnational pilot projects may not be less than 36 % of the annual budget for the programme.
46 Prevajalska redakcija
RS
EMEA
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila CIMZIA.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with CIMZIA.
47 Prevajalska redakcija
RS
EMEA
Klinični program pregabalina je zajel prek 9. 000 bolnikov, izpostavljenih temu zdravilu; 5. 000 od teh je bilo vključenih v dvojno slepa, s placebom kontrolirana preskušanja.
The pregabalin clinical programme involved over 9000 patients who were exposed to pregabalin, of whom over 5000 were in double-blind placebo controlled trials.
48 Prevajalska redakcija
RS
EMEA
Družba je obvestila CHMP, da za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Lacosamide Pain UCB Pharma, ni nobenih posledic.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
49 Prevajalska redakcija
RS
EMEA
Program kliničnega preskušanja za podporo tej kombinaciji fiksnih odmerkov je primerjal le rosiglitazon in glimepirid z monoterapijo z glimepiridom, ne pa z monoterapijo z drugimi sulfonilsečninami.
The clinical trial program in support of this fixed dose combination only compared rosiglitazone and glimepiride to glimepiride monotherapy and not to monotherapy with other sulphonylureas.
50 Prevajalska redakcija
RS
EMEA
Mednarodni program vrednotenja dolgotrajne uporabe etorikoksiba in diklofenaka pri zdravljenju artritisa (Program MEDAL - Multinational Etoricoxib and Diclofenac Arthritis Long- term Program) Program MEDAL je bil prospektivno zasnovan program vrednotenja kardiovaskularne varnosti na osnovi združenih podatkov iz treh randomiziranih, dvojno slepih, s primerjalno učinkovino primerjanih preskušanj, študije MEDAL, študije EDGE II in študije EDGE.
Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Program The MEDAL Program was a prospectively designed Cardiovascular (CV) Safety Outcomes Program of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
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program preskušanja