Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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1–16/16
safety statement
1 Končna redakcija
DRUGO
THE STATEMENTS OF SPECIAL RISKS AND THE SAFETY ADVICE ARE REPLACED BY THE FOLLOWING:
Simbol VSTAVITI SIMBOL se nadomesti s simbolom VSTAVITI SIMBOL Opozorila in obvestila se nadomestijo z naslednjimi:
2 Končna redakcija
DRUGO
WHEREAS ANNEXES III AND IV TO DIRECTIVE 67/548/EEC CONTAIN STATEMENTS OF SPECIAL RISKS (R-PHRASES) AND SAFETY ADVICE (S-PHRASES);
ker prilogi III in IV Direktive 67/548/EGS vsebujeta opozorila (stavke R) in obvestila (stavke S);
3 Pravna redakcija
DRUGO
a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
izjavo, da zadevni pripomoček izpolnjuje bistvene zahteve poleg vidikov, ki jih pokrivajo preiskave, in da so bili poleg teh zahtev upoštevani vsi previdnostni ukrepi za zaščito zdravja in varnosti bolnika.
4 Pravna redakcija
DRUGO
Directive 2002/44/EC of the European Parliament and of the Council of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) - Joint Statement by the European Parliament and the Council
DIREKTIVA 2002/44/ES EVROPSKEGA PARLAMENTA IN SVETA z dne 25. junija 2002 o minimalnih zdravstvenih in varnostnih standardih zaradi izpostavljenosti delavcev tveganjem iz fizikalnih dejavnikov (vibracij) (šestnajsta posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS)
5 Prevajalska redakcija
izobraževanje
CELEX: 31998R0179
"Observation" means a statement of fact made during a safety management audit and substantiated by objective evidence.
"Opažanje" pomeni navajanje dejstev, ugotovljenih med revizijo varnega upravljanja in utemeljenih z objektivnimi dokazi.
6 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Clinical statements concerning the efficacy or safety of a medicinal product under normal conditions of use which are not scientifically substantiated cannot be accepted as valid evidence.
Kliničnih izjav o učinkovitosti ali varnosti zdravila v predpisanih pogojih uporabe, ki znanstveno niso dovolj utemeljene, ni mogoče sprejeti kot veljaven dokaz.
7 Prevajalska redakcija
izobraževanje
CELEX: 32002R1970
"Objective evidence" means quantitative or qualitative information, records or statements of fact pertaining to safety or to the existence and implementation of an safety management system element, which is based on observation, measurement or test and which can be verified.
"Objektivni dokaz" pomeni količinske ali kakovostne podatke, zapise ali izjave dejstev v zvezi z varnostjo ali obstojem ter izvedbo elementa sistema za varno upravljanje, ki temelji na opazovanju, merjenju ali preskušanju in ga je mogoče preveriti.
8 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
izjavo, da določen pripomoček izpolnjuje zahteve direktive poleg vidikov, ki so zajeti z ovrednotenjem, in poleg vidikov, ki so izrecno navedeni po postavkah v izjavi, ter da so bili sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti bolnika, uporabnika in drugih oseb.
9 Prevajalska redakcija
izobraževanje
CELEX: 31993L0072
Again the numbers are separated by either a dash or an oblique stroke, the significance of which is as in (ii) above, except that the combined statements of recommended safety precautions are set out in Annex IV.
Tudi tu so številke ločene bodisi z vezajem bodisi poševnico, katerih pomen je naveden v (ii) zgoraj, sestavljeni stavki priporočenih varnostnih ukrepov pa so določeni v Prilogi IV.
10 Prevajalska redakcija
izobraževanje
CELEX: 32003D0913
The structure of the Advisory Committee on Safety, Hygiene and Health Protection at Work should be retained with changes made to streamline its operation and with a clear statement of the horizontal nature of its competences to cover all public and private sectors of activity in accordance with the scope of Community legislation on health and safety at work.
Primerno je zadržati strukturo Svetovalnega odbora za varnost, higieno in varovanje zdravja pri delu, napraviti določene spremembe za racionalizacijo njegovega delovanja in ob jasni določitvi horizontalne narave njegovih pristojnosti, s čimer bi zajeli vse javne in zasebne dejavnosti v skladu z zakonodajo Skupnosti na področju zdravja in varnosti pri delu.
11 Prevajalska redakcija
izobraževanje
CELEX: 31998R0179
"Objective evidence" means quantitative or qualitative information, records or statements of fact pertaining to safety or to the existence and implementation of a SMS element, which is based on observation, measurement or test and which can be verified.
"Objektivni dokaz" pomeni količinske ali kakovostne informacije, zapise ali izjave dejstev v zvezi z varnostjo ali obstojem ter izvedbo elementa SMS, ki temelji na opazovanju, merjenju ali preskušanju in ga je mogoče preveriti.
12 Prevajalska redakcija
izobraževanje
CELEX: 32003L0025
The Council entered a statement in the minutes of the 2074th Council meeting of 17 March 1998 stressing the need to ensure the same level of safety for all passenger ferries operating in similar conditions, whether on international or on domestic voyages.
Svet je v zapisnik 2 074. seje Sveta dne 17. marca 1998 vključil izjavo, v kateri je poudaril potrebo po zagotavljanju enake varnostne ravni za vse RO-RO potniške trajekte, ki obratujejo v podobnih razmerah, bodisi na mednarodnih bodisi domačih potovanjih.
13 Prevajalska redakcija
izobraževanje
CELEX: 31990L0385
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
izjavo, ki potrjuje, da zadevni pripomoček izpolnjuje bistvene zahteve, razen vidikov, ki sestavljajo cilj preskušanj, in da so glede na te vidike sprejeti vsi varnostni ukrepi za zaščito zdravja in pacienta.
14 Prevajalska redakcija
RS
EMEA
CVMP received SPCs, a master reference dossier on residues and withdrawal periods, residue studies, efficacy data and periodic safety update reports, an expert statement on the efficacy including reference papers, pharmacokinetic data, antimicrobial resistance information and MIC/ resistance data.
Odbor CVMP je prejel povzetke glavnih značilnosti zdravila, glavno referenčno dokumentacijo o ostankih in karencah, študije ostankov, podatke o učinkovitosti in periodična poročila o varnosti, izjavo strokovnjakov o učinkovitosti skupaj z referenčnimi znanstvenimi razpravami, podatke o farmakokinetiki, podatke o odpornosti na antibiotike in podatke o MIK/ odpornosti.
15 Prevajalska redakcija
izobraževanje
CELEX: 32000L0070
"- a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device.";
" - izjavo o tem, ali pripomoček vsebuje kot sestavni del snov ali derivat človeške krvi iz oddelka 7.4 Priloge I ali ne, in podatke o preskusih, potrebnih za ugotavljanje varnosti, kakovosti in uporabnosti te snovi ali derivata človeške krvi, ki so bili v zvezi s tem izvedeni, ob upoštevanju predvidenega namena pripomočka.";
16 Prevajalska redakcija
RS
EMEA
The CHMP noted that an active pharmacovigilance system is in place in Italy since 1975 guaranteeing a strict control of the adverse events linked to medicinal products and that the Italian pharmacovigilance database does not contain a single suspected adverse reaction signal related to UMAN BIG, which is consistent with the statement of the Applicant of the safety of UMAN BIG.
Odbor CHMP je ugotovil, da je v Italiji prisoten aktiven sistem farmakovigilance od leta 1975, kar zagotavlja strogo nadzorovanje neželenih učinkov, ki so povezani z zdravili, in da zbirka podatkov italijanske farmakovigilance ne vsebuje niti enega suma na neželeni učinek, ki bi bil povezan z zdravilom UMAN BIG, kar je skladno z izjavo predlagatelja o varnosti zdravila UMAN BIG.
Prevodi: en > sl
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safety statement