natgillin/translations-raw huggingface dataset:
The air conditioner model shall be considered to comply with the requirements set out in this Regulation, as applicable, if the average of the maximum sound power level does not exceed more than 2 dB(A) of the declared value.
Model klimatske naprave je skladen z zahtevami iz te uredbe, kot je ustrezno, če povprečna vrednost najvišje ravni zvočne moči ne presega več kot 2 dB(A) prijavljene vrednosti.
For the purposes of checking conformity with the requirements of this Regulation, Member States shall apply the procedures referred to in Annex II, and harmonised standards the reference numbers of which have been published in the Official Journal of the European Union, or other reliable, accurate and reproducible calculation and measurement methods, which take into account the generally recognised state-of-the-art.
Države članice zaradi preverjanja skladnosti z zahtevami iz te uredbe uporabljajo postopke iz Priloge II in usklajene standarde, referenčne številke katerih so bile objavljene v Uradnem listu Evropske unije, in druge zanesljive, točne in ponovljive metode za izračun in merjenje, ki upoštevajo splošno priznane najsodobnejše merilne metode.
At the time of entry into force of this Regulation, the best available technology on the market for air conditioners in terms of their energy performance was identified as follows:
Ob začetku veljavnosti te uredbe je bila najboljša razpoložljiva tehnologija, ki je za klimatske naprave na voljo na trgu v smislu njihove energetske učinkovitosti, opredeljena tako:
Benchmarks for air conditioners
Merila uspešnosti za klimatske naprave
Benchmark for the level of GWP of the refrigerant used in the air conditioner is GWP ≤ 20.
Merilo uspešnosti za raven GWP hladilnega sredstva, uporabljenega za klimatsko napravo, je GWP ≤ 20.
Air conditioners, excluding double duct and single duct air conditioners
Klimatske naprave, razen dvo- in enokanalnih klimatskih naprav
Based on efficiency of evaporatively cooled single duct air conditioners.
Na podlagi učinkovitosti enokanalnih klimatskih naprav, ki se hladijo s hlapi.
The annual electricity consumption of products subject to this Regulation was estimated to have been 30 TWh in the EU in 2005.
Letna poraba električne energije izdelkov iz te uredbe v EU je leta 2005 po ocenah znašala 30 TWh.
Unless specific measures are taken, annual electricity consumption is predicted to be 74 TWh in 2020.
Če ne bodo sprejeti posebni ukrepi, bo letna poraba električne energije leta 2020 po predvidevanjih znašala 74 TWh.
The preparatory study shows that the electricity consumption of products subject to this Regulation can be significantly reduced.
Pripravljalna študija kaže, da je mogoče porabo električne energije izdelkov iz te uredbe bistveno zmanjšati.
Jenkins, J.J.
Houghton, G.J.
A Report of the Intergovernmental Panel on Climate Change: http://www.ipcc.ch/publications_and_data/publications_and_data_reports.shtml
Poročilo Medvladnega foruma o podnebnih spremembah: http://www.ipcc.ch/publications_and_data/publications_and_data_reports.shtml
Climate Change, The IPCC Scientific Assessment, J.T. Houghton, G.J.
Podnebne spremembe, Znanstvena presoja IPCC, J.T.
The Commission shall review this Regulation in the light of technological progress and present the result of this review to the Ecodesign Consultation Forum no later than 5 years from the date of the entry into force of this Regulation. The review shall in particular assess the efficiency and sound power level requirements, the approach to promote the use of low- global warming potential (GWP) refrigerants and the scope of the Regulation for air conditioners and possible changes in market share of types of appliances, including air conditioners above 12 kW rated output power.
V pregledu morajo biti ocenjeni zlasti zahteve glede učinkovitosti in ravni zvočne moči, pristop k spodbujanju uporabe hladilnih sredstev z nizkim potencialom globalnega segrevanja (GWP) in področje uporabe uredbe za klimatske naprave ter morebitne spremembe tržnega deleža vrst naprav, vključno s klimatskimi napravami z nazivno izhodno močjo nad 12 kW.
Commission Regulation (EU) No 207/2012
Uredba Komisije (EU) št. 207/2012
on electronic instructions for use of medical devices
o elektronskih navodilih za uporabo medicinskih pripomočkov
Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [1], and in particular Article 9(10) thereof,
ob upoštevanju Direktive Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [1] in zlasti člena 9(10) Direktive,
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [2], and in particular Article 11(14) thereof,
ob upoštevanju Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [2] in zlasti člena 11(14) Direktive,
For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users.
Za nekatere medicinske pripomočke je lahko zagotovitev navodil za uporabo v elektronski obliki namesto na papirju koristna za poklicne uporabnike.
It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety.
S tem se lahko zmanjša obremenitev okolja in izboljša konkurenčnost industrije medicinskih pripomočkov z zmanjšanjem stroškov, obenem pa ohranja enako ali višjo raven varnosti.
Such possibility of providing instructions for use in electronic form instead of in paper form should be limited to certain medical devices and accessories intended to be used in specific conditions.
Taka možnost zagotavljanja navodil za uporabo v elektronski obliki namesto na papirju mora biti omejena na nekatere medicinske pripomočke in dodatke, namenjene uporabi pod posebnimi pogoji.
In any case, for reasons of safety and efficiency users should always have the possibility to obtain those instructions for use in paper form on request.
Vsekakor pa morajo imeti uporabniki zaradi varnosti in učinkovitosti vedno možnost, da na zahtevo prejmejo navedena navodila za uporabo na papirju.
In order to reduce potential risks as far as possible, the appropriateness of the provision of instructions for use in electronic form should be subject to a specific risk assessment by the manufacturer.
Za optimalno zmanjšanje morebitnih tveganj mora proizvajalec izvesti posebno oceno tveganja o primernosti zagotovitve navodil za uporabo v elektronski obliki.
In order to ensure that users have access to the instructions for use, appropriate information about access to those instructions for use in electronic form and about the right to request the instructions for use in paper form, should be provided.
Da se uporabnikom zagotovi dostop do navodil za uporabo, morajo biti zagotovljene ustrezne informacije o dostopu do navedenih navodil za uporabo v elektronski obliki in o pravici do zahteve za pridobitev navodil za uporabo na papirju.
To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website.
Da se zagotovi brezpogojen dostop do navodil za uporabo v elektronski obliki ter olajša sporočanje o posodobitvah in opozorilih o proizvodih, morajo biti navodila za uporabo v elektronski obliki na voljo tudi prek spletne strani.
Regardless of the language obligations imposed on manufacturers by the law of the Member States, manufacturers who provide instructions for use in electronic form should indicate on their website in which Union languages those instructions are available.
Ne glede na jezikovne obveznosti, ki jih proizvajalcem nalaga zakonodaja držav članic, morajo proizvajalci, ki zagotavljajo navodila za uporabo v elektronski obliki, na svoji spletni strani navesti, v katerih jezikih so navedena navodila na voljo.
Except for medical devices of Class I, as defined in Annex IX to Directive 93/42/EEC, the fulfilment of the obligations laid down in this Regulation should be reviewed by a notified body during the procedure applicable for conformity assessment based on a specific sampling method.
Razen za medicinske pripomočke iz razreda I, kakor so opredeljeni v Prilogi IX k Direktivi 93/42/EGS, mora priglašeni organ pregledati izpolnjevanje obveznosti iz te uredbe med postopkom, ki se uporablja za ocenjevanje skladnosti, ki temelji na posebni metodi vzorčenja.
As the protection of the right to privacy of natural persons with respect to the processing of personal data should be ensured by manufacturers and notified bodies as well, it is appropriate to provide that websites containing instructions for use of a medical device fulfil the requirements of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [3].
Ker morajo proizvajalci in priglašeni organi zagotoviti varstvo pravice do zasebnosti fizičnih oseb glede obdelave osebnih podatkov, je primerno zagotoviti, da spletne stani, ki vsebujejo navodila za uporabo medicinskega pripomočka, ustrezajo zahtevam iz Direktive Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [3].
In order to ensure safety and consistency, instructions for use in electronic form which are provided in addition to complete instructions for use in paper form should be covered by this Regulation as regards limited requirements in relation to their contents and websites.
Za zagotovitev varnosti in doslednosti mora ta uredba urejati navodila za uporabo v elektronski obliki, ki so na voljo poleg popolnih navodil za uporabo na papirju, glede omejenih zahtev v povezavi z njenimi vsebinami in spletnimi stranmi.
It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system and to allow all operators and Member States time to adapt to it.
Ustrezno je zagotoviti čas za prilagoditev uporabi te uredbe, da se omogoči nemoten prehod na nov sistem in vsem državam članicam omogoči dovolj časa za njeno sprejetje.
The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC,
Ukrepi, predvideni s to direktivo, so v skladu z mnenjem odbora, ustanovljenega s členom 6(2) Direktive 90/385/EGS –
This Regulation establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC may be provided in electronic form instead of in paper form.
Ta uredba določa pogoje, pod katerimi se lahko navodila za uporabo za medicinske pripomočke iz točke 15 Priloge 1 k Direktivi 90/385/EGS in točke 13 Priloge I k Direktivi 93/42/EGS zagotavljajo v elektronski obliki namesto na papirju.
It also establishes certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form relating to their contents and websites.
Prav tako določa nekatere zahteve glede navodil za uporabo v elektronski obliki, ki so zagotovljena poleg popolnih navodil za uporabo na papirju, v zvezi z njihovimi vsebinami in spletnimi stranmi.
‘instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its expected performances and of any precautions to be taken as outlined in the relevant parts of point 15 of Annex 1 to Directive 90/385/EEC and of point 13 of Annex I to Directive 93/42/EEC;
„navodila za uporabo“ pomenijo informacije, ki jih proizvajalec zagotovi, da uporabnika obvesti o pripomočku, njegovi varni in pravilni uporabi, predvidenem delovanju in kakršnih koli varnostnih ukrepih, ki jih je treba sprejeti, kot je opisano v ustreznih delih točke 15 Priloge 1 k Direktivi 90/385/EGS in točke 13 Priloge I k Direktivi 93/42/EGS;
‘instructions for use in electronic form’ means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or instructions for use available through a website;
„navodila za uporabo v elektronski obliki“ pomenijo navodila za uporabo, prikazana v elektronski obliki s pripomočkom, ki so v prenosnem elektronskem nosilcu podatkov, zagotovljenem s strani proizvajalca skupaj s pripomočkom, ali navodila za uporabo, ki so na voljo na spletni strani;
‘professional users’ means persons using the medical device in the course of their work and in the framework of a professional healthcare activity;
„poklicni uporabniki“ pomenijo osebe, ki uporabljajo medicinski pripomoček pri svojem delu in v okviru poklicne dejavnosti zdravstvenega varstva;
‘fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a specific location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility.
„pritrjeni nameščeni medicinski pripomočki“ pomenijo pripomočke in njihove dodatke, ki so namenjeni namestitvi, pritrditvi ali drugačni pričvrstitvi na določeno mesto v zdravstveni ustanovi, da jih ni mogoče premakniti s tega mesta ali odstraniti brez orodja ali naprave, in niso posebej namenjeni uporabi znotraj mobilne zdravstvene ustanove.
Subject to the conditions set out in paragraph 2, manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:
Ob upoštevanju pogojev iz odstavka 2 lahko proizvajalci zagotovijo navodila za uporabo v elektronski obliki namesto na papirju, kadar so navedena navodila povezana s katerimi koli od naslednjih pripomočkov:
active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
aktivnimi medicinskimi pripomočki za vsaditev in njihovimi dodatki, ki jih zajema Direktiva 90/385/EGS ter so namenjeni izključno za vsaditev ali programiranje opredeljenega aktivnega medicinskega pripomočka za vsaditev;
implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;
medicinskimi pripomočki za vsaditev in njihovimi dodatki, ki jih zajema Direktiva 93/42/EGS ter so namenjeni izključno za vsaditev opredeljenega medicinskega pripomočka za vsaditev;
fixed installed medical devices covered by Directive 93/42/EEC;
pritrjenimi nameščenimi medicinskimi pripomočki, ki jih zajema Direktiva 93/42/EGS;
medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;
medicinskimi pripomočki in njihovimi dodatki, ki jih zajemata direktivi 90/385/EGS in 93/42/EGS ter imajo vgrajen sistem za vizualni prikaz navodil za uporabo;
stand-alone software covered by Directive 93/42/EEC.
samostojno programsko opremo, ki jo zajema Direktiva 93/42/EGS.
Manufacturers may provide instructions for use in electronic form instead of in paper form for the devices listed in paragraph 1 under the following conditions:
Proizvajalci lahko zagotovijo navodila za uporabo v elektronski obliki namesto na papirju za pripomočke, navedene v odstavku 1, pod naslednjimi pogoji:
the devices and accessories are intended for exclusive use by professional users;
pripomočki in dodatki so namenjeni izključno poklicnim uporabnikom;
the use by other persons is not reasonably foreseeable.
uporaba s strani drugih oseb ni razumno predvidljiva.
Manufacturers of devices referred to in Article 3 that provide instructions for use in electronic form instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements:
Proizvajalci pripomočkov iz člena 3, ki zagotavljajo navodila za uporabo v elektronski obliki namesto na papirju, izvedejo dokumentirano oceno tveganja, ki zajema najmanj naslednje elemente:
knowledge and experience of the intended users in particular regarding the use of the device and user needs;
znanje in izkušnje predvidenih uporabnikov zlasti glede uporabe pripomočka in potreb uporabnikov;
characteristics of the environment in which the device will be used;
značilnosti okolja, v katerem se bo pripomoček uporabljal;
knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
znanje in izkušnje predvidenega uporabnika o strojni in programski opremi, ki je potrebna za prikaz navodil za uporabo v elektronski obliki;
access of the user to the reasonably foreseeable electronic resources needed at the time of use;
dostop uporabnika do razumno predvidljivih elektronskih virov, ki so potrebni v času uporabe;
performance of safeguards to ensure that the electronic data and content are protected from tampering;
delovanje zaščitnih ukrepov za zagotovitev, da se elektronski podatki in vsebina zaščitijo pred nedovoljenim spreminjanjem;
safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;
varnostne in nadomestne mehanizme v primeru napake strojne ali programske opreme, zlasti če so navodila za uporabo del pripomočka;
foreseeable medical emergency situations requiring the provision of information in paper form;
predvidljive krizne zdravstvene razmere, v katerih morajo biti informacije zagotovljene na papirju;
impact caused by the temporary unavailability of the specific website or of the Internet in general, or of their access in the healthcare facility as well as the safety measures available to cope with such a situation;
učinek, ki bi ga imela začasna nedostopnost določene spletne strani ali interneta na splošno ali onemogočen dostop v zdravstveni ustanovi, ter varnostne ukrepe, ki so na voljo za ukrepanje v takih razmerah;
evaluation of the time period within which the instructions for use shall be provided in paper form at the users request.
ocena časovnega obdobja, v katerem je treba na zahtevo uporabnika zagotoviti navodila za uporabo na papirju.
The risk assessment for the provision of the instructions for use in electronic form shall be updated in view of the experience gained in the post-marketing phase.
Oceno tveganja za zagotovitev navodil za uporabo v elektronski obliki je treba posodobiti z vidika pridobljenih izkušenj v poprodajni fazi.
Manufacturers of devices referred to in Article 3 may provide instructions for use in electronic form instead of in paper form under the following conditions:
Proizvajalci pripomočkov iz člena 3 lahko zagotovijo navodila za uporabo v elektronski obliki namesto na papirju pod naslednjimi pogoji:
the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;
iz ocene tveganja iz člena 4 je razvidno, da zagotavljanje navodil za uporabo v elektronski obliki ohranja ali izboljša raven varnosti, doseženo z zagotavljanjem navodil za uporabo na papirju;
they shall provide instructions for use in electronic form in all Member States where the product is made available or put into service, unless duly justified in the risk assessment referred to in Article 4;
navodila za uporabo v elektronski obliki zagotovijo v vseh državah članicah, v katerih je proizvod na voljo ali se uporablja, razen če ni ustrezno utemeljeno v oceni učinka iz člena 4;
they shall have a system in place to provide the instructions for use in printed paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;
imajo vzpostavljen sistem za zagotavljanje navodil za uporabo v tiskani obliki na papirju brez dodatnih stroškov za uporabnika v časovnem obdobju, določenem v oceni tveganja iz člena 4, in najpozneje v sedmih koledarskih dneh po prejemu zahteve uporabnika ali ob dostavi pripomočka, če je bila taka zahteva izražena ob naročilu;
they shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device;
na pripomočku ali zloženki zagotovijo informacije o predvidljivih kriznih zdravstvenih razmerah in za pripomočke z vgrajenim sistemom za vizualni prikaz navodil za uporabo informacije o tem, kako aktivirati pripomoček;
they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect;
zagotovijo ustrezno oblikovanje in delovanje navodil za uporabo v elektronski obliki ter v ta namen zagotovijo dokaze o preverjanju in potrjevanju;
for medical devices fitted with a built-in system visually displaying the instructions for use, they shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular life-monitoring or life-supporting functions;
za medicinske pripomočke, ki imajo vgrajen sistem za vizualni prikaz navodil za uporabo, zagotovijo, da prikaz navodil za uporabo ne ovira varne uporabe pripomočka, zlasti funkcij spremljanja življenja ali ohranjanja življenjskih funkcij;
they shall provide, in their catalogue or in other appropriate device information support, information on software and hardware requirements needed to display the instructions for use;
zagotovijo v svojem katalogu ali na drugem ustreznem pripomočku podporne informacije ter informacije o minimalnih zahtevah strojne in programske opreme za prikaz navodil za uporabo;
they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;
imajo vzpostavljen sistem, s katerim jasno navedejo, ko se navodila za uporabo spremenijo, ter s katerim obvestijo vsakega uporabnika tega pripomočka, če je bila sprememba potrebna iz varnostnih razlogov;
for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for the users in electronic form for at least 2 years after the end of the expiry date of the last produced device;
za pripomočke z določenim rokom trajanja, razen pripomočkov za vsaditev, hranijo navodila za uporabo, ki so uporabnikom na voljo v elektronski obliki, najmanj dve leti po preteku roka trajanja zadnjega proizvedenega pripomočka;
for devices without a defined expiry date and for implantable devices, they shall keep the instructions for use available for the users in electronic form for a period of 15 years after the last device has been manufactured.
za pripomočke brez določenega roka trajanja in za pripomočke za vsaditev hranijo navodila za uporabo, ki so uporabnikom na voljo v elektronski obliki, petnajst let po tem, ko je bil proizveden zadnji pripomoček.
Manufacturers shall clearly indicate that the instructions for use of the device are supplied in electronic form instead of in paper form.
Proizvajalci jasno navedejo, da so navodila za uporabo pripomočka na voljo v elektronski obliki namesto na papirju.
That information shall be provided on the packaging for each unit or, where appropriate, on the sales packaging.
Navedene informacije se zagotovijo na embalaži vsake enote ali po potrebi na prodajni embalaži.