This question was closed without grading. Reason: Other
Feb 2, 2011 14:05
13 yrs ago
English term
IIA statement
English to Serbo-Croat
Tech/Engineering
Mechanics / Mech Engineering
CE certification of machines
In some cases XXXX can be the manufacturer of an installation, such as when a production line is
constructed. This production line may be comprised of a large number of machines that have been supplied
by different suppliers, together with an IIA statement (see Appendix II). The person responsible for the
layout should ensure a CE declaration is provided for the cluster of machines, see item 3.4.
U tekstu od 150 strana pojavljuje se samo još nekoliko puta u sklopu nekog nabrajanja.
Da se ne radi o Institute of Internal Auditors?
constructed. This production line may be comprised of a large number of machines that have been supplied
by different suppliers, together with an IIA statement (see Appendix II). The person responsible for the
layout should ensure a CE declaration is provided for the cluster of machines, see item 3.4.
U tekstu od 150 strana pojavljuje se samo još nekoliko puta u sklopu nekog nabrajanja.
Da se ne radi o Institute of Internal Auditors?
Proposed translations
(Serbo-Croat)
4 | Izveštaj 2(II)A | M. Vučković |
2 +1 | izjava u Delu IIA | Natasa Djurovic |
Proposed translations
3 hrs
Izveštaj 2(II)A
The so-called IIA statement is a generally applicable statement. The minimum information that a declaration of conformity must contain:
* Brief description of the product
* Type numbers / model numbers
* Full name and address of the manufacturer or his authorized representative established in the European Union.
* Enumeration of the directive (s).
* List of applied standards include years of publication.
* Where applicable, the name and address of the designated body (Notified Body) to the type of research conducted, the TCD has assessed which the TCD is forwarded.
* Name, position and signature of the signatory appointed by the manufacturer.
http://www.reviewbloger.com/ce-marking-and-its-control
3. The safety, quality and performance requirements for diagnostic tests for many infectious diseases are laid down in the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests included in Annex II List A of the Directive must comply with performance requirements set out in a Common Technical Specification (CTS) to receive a CE mark2. Currently, diagnostic tests for subclinical vCJD are not included in Annex IIA of the Directive and so a CTS with clear performance requirements for such tests has not yet been defined.
http://www.seac.gov.uk/statements/statement-vcjd.pdf
Mene ove reference navode na zaključak, moguće pogrešan, da je to u stvari dokument naslovljen rimskim ciframa i slovom A a ne skraćenica ustanove!
* Brief description of the product
* Type numbers / model numbers
* Full name and address of the manufacturer or his authorized representative established in the European Union.
* Enumeration of the directive (s).
* List of applied standards include years of publication.
* Where applicable, the name and address of the designated body (Notified Body) to the type of research conducted, the TCD has assessed which the TCD is forwarded.
* Name, position and signature of the signatory appointed by the manufacturer.
http://www.reviewbloger.com/ce-marking-and-its-control
3. The safety, quality and performance requirements for diagnostic tests for many infectious diseases are laid down in the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests included in Annex II List A of the Directive must comply with performance requirements set out in a Common Technical Specification (CTS) to receive a CE mark2. Currently, diagnostic tests for subclinical vCJD are not included in Annex IIA of the Directive and so a CTS with clear performance requirements for such tests has not yet been defined.
http://www.seac.gov.uk/statements/statement-vcjd.pdf
Mene ove reference navode na zaključak, moguće pogrešan, da je to u stvari dokument naslovljen rimskim ciframa i slovom A a ne skraćenica ustanove!
+1
5 hrs
izjava u Delu IIA
2. Deo dokumentacije koji se menja u registracionom EU dosijeu u delu IIC ili u odgovarajućem delu Opšteg tehničkog dokumenta (CTD).
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Note added at 5 hrs (2011-02-02 19:50:19 GMT)
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https://docs.google.com/document/d/1fP1DBO1nrbXMteJhor6ota2M...
Pogledajte u tabelarnom delu pod nazivom Dokumentacija, pominju se razne oznake Deo IIA, IIB...
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Note added at 5 hrs (2011-02-02 19:52:24 GMT)
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Procitala sam u jednom dokumentu da je nekada potrebno da proizvodjac da izjavu o nekoj promeni koja se menja u EU dosijeu. Mozda je to!
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Note added at 5 hrs (2011-02-02 19:50:19 GMT)
--------------------------------------------------
https://docs.google.com/document/d/1fP1DBO1nrbXMteJhor6ota2M...
Pogledajte u tabelarnom delu pod nazivom Dokumentacija, pominju se razne oznake Deo IIA, IIB...
--------------------------------------------------
Note added at 5 hrs (2011-02-02 19:52:24 GMT)
--------------------------------------------------
Procitala sam u jednom dokumentu da je nekada potrebno da proizvodjac da izjavu o nekoj promeni koja se menja u EU dosijeu. Mozda je to!
Peer comment(s):
agree |
zoe1
: Rekla bih da je to, a ne skraćenica.
14 hrs
|
I ja bih rekla isto Zorice, hvala!
|
Reference comments
1 hr
Reference:
IIA
A šta piše u Appendix-u 2, pošto se poziva na njega?
Pogledajte ovu ref.
http://www.docstoc.com/docs/858080/List-of-Independent-Inspe...
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Note added at 1 hr (2011-02-02 15:21:41 GMT)
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Ne znam da li ovo znači da ova agencija izdaje CE sertifikate, pošto je to navedeno?
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Note added at 1 hr (2011-02-02 15:31:20 GMT)
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http://www.abbreviations.com/IIA
Pogledajte ovu ref.
http://www.docstoc.com/docs/858080/List-of-Independent-Inspe...
--------------------------------------------------
Note added at 1 hr (2011-02-02 15:21:41 GMT)
--------------------------------------------------
Ne znam da li ovo znači da ova agencija izdaje CE sertifikate, pošto je to navedeno?
--------------------------------------------------
Note added at 1 hr (2011-02-02 15:31:20 GMT)
--------------------------------------------------
http://www.abbreviations.com/IIA
Note from asker:
Nemam appendix 2, na žalost |
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