#632857
an nós imeachta um measúnú comhréireachta a leanadh;
conformity assessment procedure followed;
an nós imeachta um measúnú comhréireachta a leanadh;
conformity assessment procedure followed;
Nós imeachta um measúnú comhréireachta d'fhochórais
Conformity assessment procedure for subsystems
Ní thagrófar i ngach deimhniú ach do nós imeachta amháin um measúnú comhréireachta.
Each certificate shall refer to only one conformity assessment procedure.
Ní thagrófar le gach deimhniú ach do nós imeachta amháin um measúnú comhréireachta.
Each certificate shall refer to only one conformity assessment procedure.
NÓS IMEACHTA UM MEASÚNÚ COMHRÉIREACHTA — TÁIRGÍ
CONFORMITY ASSESSMENT PROCEDURE – PRODUCTS
gur chuir soláthraí an chórais intleachta saorga sin an nós imeachta iomchuí um measúnú comhréireachta i bhfeidhm
the appropriate conformity assessment procedure has been carried out by the provider of that AI system
an nós imeachta um measúnú comhréireachta bunaithe ar rialú inmheánach dá dtagraítear in Iarscríbhinn VI;
the conformity assessment procedure based on internal control referred to in Annex VI;
An nós imeachta um measúnú comhréireachta bunaithe ar rialú inmheánach, is é sin an nós imeachta um measúnú comhréireachta bunaithe ar phointí 2 go 4.
The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2 to 4.
Maolú ar an nós imeachta um measúnú comhréireachta
Derogation from conformity assessment procedure
NÓS IMEACHTA UM MEASÚNÚ COMHRÉIREACHTA BUNAITHE AR RIALÚ INMHEÁNACH
CONFORMITY ASSESSMENT PROCEDURE BASED ON INTERNAL CONTROL
(3) Déantar cur síos ar an nós imeachta um measúnú comhréireachta i bpointe 6.2.3.15.’;
(3) The conformity assessment procedure is described in point 6.2.3.15.’;
(2) Sonraítear an nós imeachta um measúnú comhréireachta i bpointe 6.2.3.17.’;
(2) The conformity assessment procedure is specified in point 6.2.3.17.’;
Tugtar tuairisc ar an nós imeachta um measúnú comhréireachta sa tsonraíocht dá dtagraítear in Aguisín J-1, Innéacs [50 ].’;
The conformity assessment procedure is described in specification referenced to in Appendix J-1, Index [50].’;
nós imeachta um measúnú comhréireachta
conformity assessment procedure
Beidh an nós imeachta um measúnú comhréireachta i gcomhréir le pointe 6.2.3.7 (7).’;
The conformity assessment procedure shall be in accordance with point 6.2.3.7 (7).’;
Aon Pháirtí a thugann isteach nós imeachta éagsúil teicniúil náisiúnta, marcáil náisiúnta nó nós imeachta náisiúnta um measúnú comhréireachta dá dtagraítear i mír 1, arna iarraidh sin don Pháirtí eile, déanfaidh sé na codanna den rialachán teicniúil náisiúnta, den mharcáil nó den nós imeachta um measúnú comhréireachta atá éagsúil go substaintiúil ó na Rialacháin ábhartha de chuid na Náisiún Aontaithe nó ó na GTRanna a shainaithint agus tabharfaidh sé údar maith leis an éagsúlacht.
A Party which introduces a divergent domestic technical regulation, marking, or conformity assessment procedure as referred to in paragraph 1, at the request of the other Party, shall identify the parts of the domestic technical regulation, marking, or conformity assessment procedure which substantially diverge from the relevant UN Regulations or GTRs and provide justification for the divergence.
Feistí nár cheangail rannpháirtíocht comhlachta dá dtugtar fógra sa nós imeachta um measúnú comhréireachta de bhun Threoir 98/79/CE agus ar dréachtaíodh dearbhú comhréireachta ina leith roimh an 26 Bealtaine 2022 i gcomhréir leis an Treoir sin, agus a cheanglaíonn rannpháirtíocht comhlachta dá dtugtar fógra sa nós imeachta um measúnú comhréireachta de bhun an Rialacháin seo, féadfar iad a chur ar an margadh nó a chur i seirbhís go dtí na dátaí seo a leanas:
Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
dheonaigh údarás inniúil de chuid Ballstáit maolú ón nós imeachta um measúnú comhréireachta is infheidhme i gcomhréir le hAirteagal 59(1) den Rialachán seo nó chuir sé de cheangal ar an monaróir, i gcomhréir le hAirteagal 97(1) den Rialachán seo, an nós imeachta um measúnú comhréireachta is infheidhme a dhéanamh.”;
a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.’;
Feistí ar ina leith nár ceanglaíodh ar chomhlacht dá dtugtar fógra a bheith rannpháirteach sa nós imeachta um measúnú comhréireachta de bhun Threoir 93/42/CEE, feistí ar ina leith a tarraingíodh suas an dearbhú comhréireachta roimh an 26 Bealtaine 2021, agus feistí ar ina leith a cheanglaítear ar chomhlacht dá dtugtar fógra a bheith rannpháirteach sa nós imeachta um measúnú comhréireachta de bhun an Rialacháin seo, féadfar iad a chur ar an margadh nó a chur i seirbhís go dtí an 31 Nollaig 2028.
Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.
Aon Pháirtí a thugann isteach nós imeachta éagsúil teicniúil náisiúnta, marcáil náisiúnta nó nós imeachta náisiúnta um measúnú comhréireachta dá dtagraítear i bpointe (a) den mhír sin, arna iarraidh sin don Pháirtí eile, déanfaidh sé aon chuid den rialachán teicniúil náisiúnta, den mharcáil nó den nós imeachta um measúnú comhréireachta a imíonn go mór ó na Rialacháin ábhartha de chuid na Náisiún Aontaithe nó ó na GTRanna a shainaithint agus tabharfaidh sé míniú ar na cúiseanna atá le himeacht den sórt sin.
A Party that introduces a divergent domestic technical regulation, marking or conformity assessment procedure as referred to in point (a) of this paragraph shall, on request of the other Party, identify any part of its domestic technical regulation, marking or conformity assessment procedure that substantially deviates from the relevant UN Regulations or GTRs and provide an explanation of the reasons for such deviation.
Ina theannta sin, ní shonraítear sa Treoir an cineál nós imeachta um measúnú comhréireachta atá le cur i bhfeidhm i ndáil le fochórais.
Furthermore the Directive does not specify which type of conformity assessment procedure has to be applied to subsystems.
Is é an monaróir fochóras agus comhpháirteanna sábháilteachta is fearr atá ábalta an nós imeachta um measúnú comhréireachta iomlán a dhéanamh mar tá eolas mionsonraithe aige sin ar an bpróiseas deartha agus táirgthe.
The manufacturer of subsystems and safety components, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure.
Roimh dóibh fochóras nó comhpháirt sábháilteachta a chur ar an margadh, áiritheoidh allmhaireoirí go mbeidh an nós imeachta iomchuí um measúnú comhréireachta déanta ag an monaróir i gcomhréir le hAirteagal 18.
Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure in accordance with Article 18 has been carried out by the manufacturer.
Roimh fhochóras nó chomhpháirt sábháilteachta a chur ar an margadh, cuirfidh an monaróir an fochóras nó an chomhpháirt sábháilteachta faoi nós imeachta um measúnú comhréireachta i gcomhréir le mír 2.
Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2.
Rinneadh athbhreithniú ar liosta na dtáirgí faoi réir an nós imeachta um measúnú comhréireachta is déine chun neamhréireachtaí a bhaint amach.
The list of the products subject to the most stringent conformity assessment procedure was revised in order to remove inconsistencies.
Cineálacha áirithe TCP a chur le liosta na dtáirgí faoi réir an nós imeachta um measúnú comhréireachta is déine;
The addition of some types of PPE to the list of products subject to the most stringent conformity assessment procedure;
Is é an monaróir, a bhfuil eolas mionsonraithe aige ar an bpróiseas deartha agus táirgthe, an duine is fearr chun an nós imeachta iomlán um measúnú comhréireachta a dhéanamh.
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure.
Tarraingeoidh monaróirí suas an doiciméadacht theicniúil dá dtagraítear in Iarscríbhinn III agus déanfaidh siad na nósanna imeachta um measúnú comhréireachta is infheidhme dá dtagraítear in Airteagal 18 nó déanfar iad thar a gceann.
Manufacturers shall draw up the technical documentation referred to in Annex III and carry out the applicable conformity assessment procedure(s) referred to in Article 18 or have them carried out.
Déanfaidh monaróirí TCP atá déanta de réir toisí an nós imeachta um measúnú comhréireachta atá leagtha amach in Iarscríbhinn VI.
Manufacturers of made-to-measure PPE shall carry out the conformity assessment procedure set out in Annex VI.
Sula gcuirfidh siad TCP ar an margadh, áiritheoidh allmhaireoirí go bhfuil na nósanna imeachta um measúnú comhréireachta iomchuí, dá dtagraítear in Airteagal 18, déanta ag an monaróir.
Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure(s) referred to in Article 18 have been carried out by the manufacturer.
Le haghaidh gach nós imeachta um measúnú comhréireachta agus le haghaidh gach cineáil TCP a bhfuil fógra tugtha dó ina leith, beidh na nithe seo a leanas ar fáil do chomhlacht um measúnú comhréireachta i gcónaí:
At all times and for each conformity assessment procedure and each kind of PPE for which it has been notified, a conformity assessment body shall have at its disposal the necessary:
Áireofar leis an bhfógra sonraí iomlána na ngníomhaíochtaí um measúnú comhréireachta, na nósanna imeachta um measúnú comhréireachta agus na gcineálacha TCP lena mbaineann agus an fianú inniúlachta ábhartha.
The notification shall include full details of the conformity assessment activities, the conformity assessment procedure(s) and the kinds of PPE concerned and the relevant attestation of competence.
Roinnt cineálacha breise TCP le cur ar liosta na dtáirgí faoi réir an nós imeachta um measúnú comhréireachta is déine;
The addition of some types of PPE to the list of products subject to the most stringent conformity assessment procedure;
Roinnt cineálacha breise TCP le cur ar liosta na dtáirgí faoi réir an nós imeachta um measúnú comhréireachta is déine
The addition of some types of PPE to the list of products subject to the most stringent conformity assessment procedure
Is é an monaróir fochóras nó comhpháirteanna sábháilteachta is fearr atá ábalta an nós imeachta um measúnú comhréireachta a dhéanamh mar tá eolas mionsonraithe aige sin ar an bpróiseas deartha agus táirgthe.
The manufacturer of subsystems or safety components, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure.
Sula gcuirfidh siad fochóras nó comhpháirt sábháilteachta ar an margadh, áiritheoidh allmhaireoirí go mbeidh an nós imeachta iomchuí i leith measúnú comhréireachta, dá dtagraítear in Airteagal 18, déanta ag an monaróir.
Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 18 has been carried out by the manufacturer.
Sula gcuirtear fochóras nó comhpháirt sábháilteachta ar an margadh, cuirfidh an monaróir an fochóras nó an chomhpháirt sábháilteachta faoi réir nós imeachta um measúnú comhréireachta i gcomhréir le mír 2.
Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2.
Is é an monaróir, a bhfuil eolas mionsonraithe aige ar an bpróiseas deartha agus táirgthe, an duine is fearr chun an nós imeachta um measúnú comhréireachta a chur i gcrích.
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure.
Tarraingeoidh monaróirí suas an doiciméadacht theicniúil dá dtagraítear in Iarscríbhinn III (“doiciméadacht theicniúil”) agus cuirfidh siad i gcrích an nós imeachta um measúnú comhréireachta is infheidhme dá dtagraítear in Airteagal 19 nó socróidh siad go ndéanfar é.
Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out.
Sula gcuirfidh siad TCP ar an margadh, áiritheoidh allmhaireoirí go bhfuil an nós imeachta iomchuí um measúnú comhréireachta dá dtagraítear in Airteagal 19 curtha i gcrích ag an monaróir.
Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 19 has been carried out by the manufacturer.
Le haghaidh gach nós imeachta um measúnú comhréireachta agus le haghaidh gach cineáil TCP a bhfuil fógra tugtha dó ina leith, beidh na nithe seo a leanas ar fáil do chomhlacht um measúnú comhréireachta i gcónaí:
At all times and for each conformity assessment procedure and each kind of PPE for which it has been notified, a conformity assessment body shall have at its disposal the necessary:
Is é an monaróir, a bhfuil mioneolas ag an té sin ar an bpróiseas deartha agus táirgeachta, an duine is fearr chun an nós imeachta um measúnú comhréireachta a dhéanamh.
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure.
Tarraingeoidh monaróirí suas an doiciméadacht theicniúil dá dtagraítear in Iarscríbhinn III (“doiciméadacht theicniúil”) agus cuirfidh siad i gcrích an nós imeachta ábhartha um measúnú comhréireachta dá dtagraítear in Airteagal 14 nó socróidh siad go ndéanfar é.
Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out.
Sula ndéanfar fearas a chur ar an margadh, áiritheoidh allmhaireoirí go mbeidh an nós imeachta iomchuí um measúnú comhréireachta dá dtagraítear in Airteagal 14 curtha i gcrích ag an monaróir.
Before placing an appliance on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer.
Sula ndéanfar feisteas a chur ar an margadh, áiritheoidh allmhaireoirí go mbeidh an nós imeachta iomchuí um measúnú comhréireachta dá dtagraítear in Airteagal 14 curtha i gcrích ag an monaróir.
Before placing a fitting on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer.
Sula gcuirfear fearas nó feisteas ar an margadh, cuirfidh an monaróir faoi nós imeachta um measúnú comhréireachta é i gcomhréir le mír 2 nó le mír 3.
Before an appliance or a fitting is placed on the market, the manufacturer shall submit it to a conformity assessment procedure in accordance with paragraph 2 or 3.
Ba cheart na húdaráis inniúla a chur ar an eolas faoi na feistí ar deonaíodh deimhniú dóibh tar éis nós imeachta um measúnú comhréireachta lena mbaineann grinnscrúdú arna dhéanamh ag painéal saineolaithe.
Competent authorities should be informed about devices that have been granted a certificate following a conformity assessment procedure involving an expert panel.
a fhíorú gur dréachtaíodh dearbhú comhréireachta AE agus an doiciméadacht theicniúil agus, i gcás inarb infheidhme, go bhfuil nós imeachta iomchuí um measúnú comhréireachta curtha i gcrích ag an monaróir;
verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
Ní fhéadfaidh an monaróir iarratas a dhéanamh i gcomhthráth le níos mó ná comhlacht amháin dá dtugtar fógra don nós imeachta céanna um measúnú comhréireachta.
The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
Féadfaidh an comhlacht dá dtugtar fógra aon fhaisnéis nó aon sonraí a éileamh ón monaróir is gá chun an nós imeachta um measúnú comhréireachta roghnaithe a dhéanamh i gceart.
The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.