active implantable medical device oor Iers
active implantable medical device
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active implantable medical devices as defined in Article #(c) of Directive #/#/EEC
roghnaigh teist ar dtúsoj4 oj4
(b) active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC;
cóireáil iarbhuainteEurLex-2 EurLex-2
Active implantable medical devices (e.g. pacemakers, implantable defibrillators) covered by the AIMDD fall de facto into class III.
Tagrófar do na Ballstáit sin sa Chonradh seo mar Ballstáit go maolúEurLex-2 EurLex-2
active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC;
Measann an Chomhdháil, nuair nach mbeidh náisiúnaigh de chuid na mBallstát uile ina gcomhaltaí den Choimisiún a thuilleadh, gur chóir don Choimisiún aird ar leith a thabhairt ar an ngá atá ann trédhearcacht iomlán a áirithiú ina chaidreamh leis na Ballstáit uileEurLex-2 EurLex-2
active implantable medical device
In ábhair a thig faoin gcomhbheartas eachtrach agus slándála, is í an Uachtaránacht a fheidhmeoidh ar son an Aontaislangbot langbot
active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC;
Cuirtear an mhír seo a leanas le hAirteagal #anot-set not-set
active implantable medical device
I gcás go gcuirfidh an Danmhairg in iúl nach mbeidh sí rannpháirteach sa tríú céim, beidh maolú ag an Danmhairglangbot langbot
Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices
tagraíonn poncúlacht don mhoill idir dáta eisiúna na sonraí agus an spriocdháta faoinar cheart iad a bheith seachadtaoj4 oj4
Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices.
Ní cuid den traidisiún sa Chomhphobal é cait ná madraí a thógáil chun fionnadh a tháirgeadh, cé go raibh cásanna de mhonarú fionnaidh cat agus fionnaidh madraí annEurLex-2 EurLex-2
where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin
Beidh feidhm ghinearálta ag rialachánoj4 oj4
where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin;
Dhá mhí a bheidh sa tréimhse a leagtar síos in Airteagal # de Chinneadh #/#/CEEurLex-2 EurLex-2
(iv) where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin;
na tascanna a fheidhmiú atá riachtanach d'fheidhmiú aerárthaí; nóEurLex-2 EurLex-2
are active implantable medical devices or implantable accessories to active implantable medical devices, in which case they are in class III,
An Bhílearúisnot-set not-set
– are active implantable medical devices or implantable accessories to active implantable medical devices, in which case they are in class III,
Ba chóir go n-úsáidfeadh staidreamh uile na mBallstát a tharchuirtear chuig an gCoimisiún agus a dhéantar a mhiondealú de réir aonad críochach, an t-aicmiú NUTS, más infheidhmeEurLex-2 EurLex-2
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable medical devices are in class III.
De bhrí go bhfuil léargas ag an nGníomhaireacht ar na húdaráis rialúcháin náisiúnta, ba cheart go mbeadh ról comhairleach aici i leith an Choimisiúin i dtaca le ceisteanna rialúcháin margaidhnot-set not-set
, 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
Chun rochtain ar fhaisnéis faoi úsáid an phríomh-bhonneagair go léir ar an dorchla lasta a éascú agus chun rochtain neamh-idirdhealaitheach ar an dorchla sin a ráthú, ba cheart don bhord bainistíochta doiciméad ina mbeadh an fhaisnéis sin go léir a tharraingt suas, agus a nuashonrú agus a fhoilsiú go rialtanot-set not-set
(f) 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 [21];
Féadfaidh an sealbhóir, laistigh de mhí tar éis an fógra atá luaite in Airteagal # a fháil, a thairiscint don Choimisiún agus, más iomchuí, don iarratasóir, comhaontú speisialta a dhéanamh an t-ábhar a tharchur chun an Choiste EadránaEurLex-2 EurLex-2
An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex # to Directive #/#/EEC
Téacs atá ábhartha maidir leis an LEE agus maidir leis an Eilvéisoj4 oj4
To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable medical devices and their accessories should be in the highest risk class.
Cruthaigh liosta nua eochracha comhcheangailte bunaithe ar na comhcheangail roghnaitheEurLex-2 EurLex-2
SANCO || 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 || COM(2012)542
Ba cheart go gcuimseodh imréiteach lárnaithe áis le haghaidh úsáide dearbhuithe simplithe, cur siar an dáta a gcuirtear isteach dearbhú críochnaithe agus doiciméid a éilítear, dearbhú tréimhsiúil agus cur siar na híocaíochtaEurLex-2 EurLex-2
An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC.
Tuarascáil ar chur chun feidhmeEurLex-2 EurLex-2
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