natgillin/translations-raw huggingface dataset:
Kontrolholdet skal gennemgå den tekniske dokumentation, der er omhandlet i punkt 3.1, andet led, med henblik på at kontrollere fabrikantens evne til at fastslå de relevante krav i dette direktiv og foretage de nødvendige undersøgelser for at sikre, at det trykbærende udstyr er i overensstemmelse med disse krav.
verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 and 3.1.3 of Annex I,
Afgørelsen meddeles fabrikanten eller dennes bemyndigede repræsentant.
verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I,
Fabrikanten skal med henblik på kontrol give det bemyndigede organ adgang til konstruktions-, fremstillings-, kontrol-, prøvnings- og lagerfaciliteterne og give det alle nødvendige oplysninger, særlig:
carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety devices, if applicable.
kvalitetsregistre i henhold til konstruktionsdelen i kvalitetsstyringssystemet, f.eks. resultater af analyser, beregninger, prøvninger mv.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.
Det bemyndigede organ kan derudover aflægge uanmeldte besøg hos fabrikanten.
The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market.
Under disse besøg kan det bemyndigede organ foretage eller lade foretage prøvninger af produkter for om nødvendigt at kontrollere, om kvalitetssikringssystemet fungerer effektivt.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment.
Det bemyndigede organ udsteder en besøgsrapport og, hvis der er foretaget prøvninger, en prøvningsrapport til fabrikanten.
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process.
Fabrikanten anbringer CE-mærkningen og på det i punkt 3.1 omhandlede bemyndigede organs ansvar dette organs identifikationsnummer på hvert enkelt trykbærende udstyr, som opfylder de relevante krav i dette direktiv.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
de i punkt 3.5 omhandlede ændringer som godkendt
An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.
de i punkt 3.4 omhandlede ændringer som godkendt
MODULE G:
de i punkt 3.3, 3.4, 4.3 og 4.4, omhandlede afgørelser og rapporter fra det bemyndigede organ.
CONFORMITY BASED ON UNIT VERIFICATION
Hvert bemyndiget organ skal orientere sine bemyndigende myndigheder om udstedte eller tilbagekaldte godkendelser af kvalitetsstyringssystemer og med jævne mellemrum eller efter anmodning stille en fortegnelse over afviste, suspenderede eller på anden måde begrænsede godkendelser af kvalitetsstyringssystemer til rådighed for sine bemyndigende myndigheder.
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.
MODUL H1:
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4.
OVERENSSTEMMELSE PÅ GRUNDLAG AF FULD KVALITETSSIKRING PLUS KONSTRUKTIONSUNDERSØGELSE
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards, have not been applied.
Overensstemmelse på grundlag af fuld kvalitetssikring plus konstruktionsundersøgelse og særlig kontrol af den afsluttende verifikation er den procedure for overensstemmelsesvurdering, hvor fabrikanten opfylder de i punkt 2 og 6 omhandlede forpligtelser og på eget ansvar sikrer og erklærer, at de pågældende produkter opfylder kravene i den retsakt, som de er omfattet af.
appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.
Fabrikanten skal ved konstruktion og fremstilling og ved kontrol og prøvning af slutprodukter anvende et godkendt kvalitetsstyringssystem som beskrevet i punkt 3 og er underlagt den i punkt 5 omhandlede kontrol.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Directive.
Egnetheden af det trykbærende udstyrs tekniske konstruktion skal være blevet undersøgt efter bestemmelserne i punkt 4.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of this Directive, or have them carried out.
de tekniske konstruktionsspecifikationer, herunder standarder, som vil blive anvendt, og, når de relevante harmoniserede standarder ikke anvendes fuldt ud, de metoder, der vil blive anvendt til at sikre, at de væsentlige sikkerhedskrav i direktivet, der gælder for trykbærende udstyr, vil blive opfyldt
In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out applying other technical specifications.
de teknikker, fremgangsmåder og systematiske foranstaltninger vedrørende konstruktionskontrol og konstruktionsverifikation, der vil blive anvendt ved konstruktionen af det trykbærende udstyr, navnlig for så vidt angår materialerne, jf. punkt 4 i bilag I
In particular the notified body shall:
Ud over erfaring med kvalitetsstyringssystemer skal kontrolholdet have mindst et medlem med erfaring i vurdering på det relevante område og inden for den pågældende teknologi af trykbærende udstyr og viden om de relevante krav i dette direktiv.
examine the technical documentation with respect to the design and the manufacturing procedures,
Det bemyndigede organ vurderer de foreslåede ændringer og afgør, om det ændrede kvalitetsstyringssystem stadig opfylder de i punkt 3.2 omhandlede krav, eller om en fornyet vurdering er nødvendig.
assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,
Konstruktionsundersøgelse
approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with point 3.1.2 of Annex I,
Fabrikanten indgiver en ansøgning om konstruktionsundersøgelse for hvert enkelt trykbærende udstyr, som ikke er omfattet af en tidligere konstruktionsundersøgelse, til det i punkt 3.1 omhandlede bemyndigede organ.
verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
Ansøgningen skal gøre det muligt at forstå det trykbærende udstyrs konstruktion, fremstilling og anvendelse og skal gøre det muligt at vurdere, om de relevante krav i dette direktiv er opfyldt.
carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to in point 3.2.2 of Annex I, and examine the safety devices, if applicable.
Ansøgningen skal indeholde:
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pressure equipment, or have it affixed under its responsibility.
fabrikantens navn og adresse
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
Den tekniske dokumentation skal indeholde en beskrivelse af de gældende krav og, i det omfang det er relevant for vurderingen, af det trykbærende udstyrs konstruktion og brug.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive.
en oversigt over de harmoniserede standarder, hvis referencer er offentliggjort i Den Europæiske Unions Tidende, og som er blevet anvendt helt eller delvis, og beskrivelser af de løsninger, der er anvendt for at opfylde de væsentlige sikkerhedskrav i dette direktiv, hvis disse harmoniserede standarder ikke er blevet anvendt.
The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
støttedokumenter, der viser, at den tekniske konstruktion er velegnet.
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
I disse støttedokumenter skal nævnes al relevant dokumentation, der er blevet anvendt, særlig hvis de relevante harmoniserede standarder ikke er blevet anvendt fuldt ud; i støttedokumentationen skal om nødvendigt indgå resultaterne af prøvninger, som er blevet foretaget af fabrikantens laboratorium eller af et andet prøvningslaboratorium på dennes vegne og ansvar.
MODULE H:
Det bemyndigede organ behandler ansøgningen, og hvis konstruktionen opfylder dette direktivs krav til trykbærende udstyr, udsteder det en EU-konstruktionsundersøgelsesattest til fabrikanten.
CONFORMITY BASED ON FULL QUALITY ASSURANCE
Attesten skal indeholde fabrikantens navn og adresse, undersøgelseskonklusionerne, eventuelle betingelser for dens gyldighed og de nødvendige data til identifikation af den godkendte konstruktion.
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfies the requirements of this Directive that apply to it.
Attesten og bilagene dertil skal indeholde alle relevante oplysninger med henblik på en vurdering af de fremstillede produkters overensstemmelse med den undersøgte konstruktion, herunder, hvis det er relevant, kontrol under brug.
the technical documentation for one model of each type of pressure equipment intended to be manufactured.
Hvis typen ikke opfylder de relevante krav i dette direktiv, afviser det bemyndigede organ at udstede en konstruktionsundersøgelsesattest og oplyser ansøgeren herom og giver en detaljeret begrundelse for afslaget.
a written declaration that the same application has not been lodged with any other notified body.
Fabrikanten skal underrette det bemyndigede organ, som opbevarer den tekniske dokumentation om EU-konstruktionsundersøgelsesattesten, om alle ændringer til den godkendte konstruktion, som kan påvirke produktets overensstemmelse med de væsentlige sikkerhedskrav dette direktiv eller betingelserne for attestens gyldighed.
That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Sådanne ændringer kræver en tillægsgodkendelse fra det bemyndigede organ, der har udstedt EU-konstruktionsundersøgelsesattesten, i form af en tilføjelse til den oprindelige EU-konstruktionsundersøgelsesattest.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
Hvert bemyndiget organ oplyser sine bemyndigende myndigheder om de EU-konstruktionsundersøgelsesattester og/eller tillæg hertil, som det har udstedt eller trukket tilbage, og stiller med jævne mellemrum eller efter anmodning listen over attester og/eller eventuelle tillæg hertil, der er blevet afvist, suspenderet eller på anden måde begrænset, til rådighed for sine bemyndigende myndigheder.
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,
Hvert bemyndiget organ oplyser de øvrige bemyndigede organer om de EU-konstruktionsundersøgelsesattester og/eller tillæg hertil, som det har afvist, trukket tilbage, suspenderet eller på anden måde begrænset, og, efter begrundet anmodning, om de attester og/eller tillæg hertil, som det har udstedt.
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,
Kommissionen, medlemsstaterne og de øvrige bemyndigede organer kan efter anmodning få tilsendt en kopi af EU-konstruktionsundersøgelsesattesterne og/eller tillæggene hertil.
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
Efter anmodning kan Kommissionen og medlemsstaterne få tilsendt en kopi af den tekniske dokumentation og resultaterne af de undersøgelser, som det bemyndigede organ har foretaget.
the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,
Det bemyndigede organ opbevarer et eksemplar af EU-konstruktionsundersøgelsesattesten, bilagene og tillæggene hertil samt den tekniske dokumentation, herunder den dokumentation, som fabrikanten har indgivet, indtil udløbet af attestens gyldighedsperiode.
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,
Fabrikanten opbevarer et eksemplar af EU-konstruktionsundersøgelsesattesten, bilagene og tillæggene hertil samt den tekniske dokumentation, så disse dokumenter i ti år efter, at det trykbærende udstyr er blevet bragt i omsætning, står til rådighed for de nationale myndigheder.
the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.
Fabrikanten skal give det bemyndigede organ adgang til at kontrollere konstruktions-, produktions-, inspektions-, prøvnings- og lagerfaciliteterne og give det alle nødvendige oplysninger, særlig:
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
kvalitetsrapporter som fastsat i konstruktionsdelen af kvalitetsstyringssystemet, f.eks. resultater af analyser, beregninger, prøver osv.
The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.
kvalitetsrapporter som fastsat i produktionsdelen af kvalitetsstyringssystemet, f.eks. kontrolrapporter og prøvningsdata, kalibreringsdata, rapporter om personalets kvalifikationer osv.
The manufacturer or his authorised representative shall be notified of the decision.
Der skal i dette kontrolbesøgssystem navnlig tages hensyn til nedenstående faktorer:
The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
Særlig kontrol af den afsluttende verifikation
the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
For den i punkt 3.2 i bilag I omhandlede afsluttende verifikation gælder en skærpet kontrol i form af uanmeldte kontrolbesøg af det bemyndigede organ.
the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
I forbindelse med disse besøg, skal det bemyndigede organ foretage kontrol af det trykbærende udstyr.
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
Det skal af EU-overensstemmelseserklæringen fremgå, hvilken model trykbærende udstyr den vedrører, og nummeret på konstruktionsundersøgelsesattesten skal være anført.
In addition, the notified body may pay unexpected visits to the manufacturer.
Fabrikantens bemyndigede repræsentant kan indgive den i punkt 4.1 og 4.2 omhandlede ansøgning og opfylde de i punkt 3.1, 3.5, 4.4, 4.6, 6 og 7 omhandlede forpligtelser på fabrikantens vegne og ansvar, forudsat at de er specificeret i mandatet.
During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system.
BILAG IV
It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
EU-OVERENSSTEMMELSESERKLÆRING (Nr. XXXX) [1]
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.
Trykbærende udstyr eller enhed (produkt-, type- batch- eller serienummer)
the technical documentation referred to in point 3.1,
Navn og adresse på fabrikanten og, hvis det er relevant, dennes bemyndigede repræsentant
the documentation concerning the quality system referred to in point 3.1,
Denne overensstemmelseserklæring udstedes på fabrikantens ansvar.
the change referred to point 3.4, as approved,
Erklæringens genstand (identifikation af det trykbærende udstyr eller enheden, så de kan spores.
the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4.
Såfremt det er nødvendigt for at kunne identificere det trykbærende udstyr eller enheden, kan der vedlægges et foto):
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
beskrivelse af det trykbærende udstyr eller enheden
MODULE H1:
anvendt procedure for overensstemmelsesvurdering
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
ved enheder: en beskrivelse af det trykbærende udstyr, som enheden består af, samt anførelse af anvendte procedurer for overensstemmelsesvurdering
Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that apply to it.
Genstanden for erklæringen, som beskrevet ovenfor, er i overensstemmelse med den relevante EU-harmoniseringslovgivning:
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
Referencer til de relevante anvendte harmoniserede standarder eller til de andre tekniske specifikationer, som der erklæres overensstemmelse med:
The adequacy of the technical design of the pressure equipment shall have been examined in accordance with point 4.
Hvor det er relevant navn, adresse og nummer på det bemyndigede organ, der har foretaget overensstemmelsesvurderingen, og nummeret på den udstedte attest og en henvisning til EU-typeafprøvningsattesten — produktionstype, EU-typeafprøvningsattesten — konstruktionstype, EU-konstruktionsafprøvningsattesten eller overensstemmelsesattesten.
the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that apply to the pressure equipment will be met,
Supplerende oplysninger:
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance with point 4 of Annex I,
Underskrevet for og på vegne af:
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
(udstedelsessted og -dato):
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.
(navn, stilling) (underskrift):
Design examination
(eventuelt identifikation af den underskriver, der har fuldmagt til at forpligte fabrikanten eller dennes i bemyndigede repræsentant)
The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by a previous design examination with the notified body referred to in point 3.1.
Det er valgfrit, om fabrikanten vil tildele overensstemmelsen et nummer.
The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and to assess the conformity with the requirements of this Directive that apply to it.
BILAG V
It shall include:
DEL A
the name and address of the manufacturer,
Ophævet direktiv med oversigt over successive ændringer
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the pressure equipment.
(jf. artikel 50)
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive, where those harmonised standards have not been applied.
Europa-Parlamentets og Rådets direktiv 97/23/EF
the supporting evidence for the adequacy of the technical design.
Europa-Parlamentets og Rådets forordning (EF) nr. 1882/2003
The notified body shall examine the application, and where the design meets the requirements of this Directive that apply to the pressure equipment it shall issue an EU design examination certificate to the manufacturer.