CE-IVD

Spanish translation: CE-IVD

17:30 Apr 15, 2005
Italian to Spanish translations [PRO]
Science - Medical: Instruments
Italian term or phrase: CE-IVD
Tutti i kit sono marcati FDA e CE-IVD per l’uso diagnostico in vitro.
Cristina Canivell
Local time: 22:10
Spanish translation:CE-IVD
Explanation:

Se queda tal cual. Es una marca distintiva que deben llevar determinados productos según las normativas de la UE.

presentar el símbolo CE-IVD y no están disponibles en la actualidad para su.
comercialización en Europa para diagnósticos in vitro. ...
pri.dakocytomation.com/0000631_ rev_-_man_artisan_handbook_spanish.pdf


PDF] Versión 1.0
Formato de archivo: PDF/Adobe Acrobat - Versión en HTML
... productos IVD deben llevar el marcado CE. para poder ser comercializados ...
Directiva IVD. Nuestros productos. incorporarán el marcado CE en el momento ...
www.dakocytomation.es/ce-folleto.pdf - Páginas similares

Selected response from:

Sonia López Grande
Spain
Local time: 22:10
Grading comment
Graded automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +2CE-IVD
Sonia López Grande
5 +1CE-IVD
Elena Sgarbo (X)


  

Answers


13 mins   confidence: Answerer confidence 5/5 peer agreement (net): +2
CE-IVD


Explanation:

Se queda tal cual. Es una marca distintiva que deben llevar determinados productos según las normativas de la UE.

presentar el símbolo CE-IVD y no están disponibles en la actualidad para su.
comercialización en Europa para diagnósticos in vitro. ...
pri.dakocytomation.com/0000631_ rev_-_man_artisan_handbook_spanish.pdf


PDF] Versión 1.0
Formato de archivo: PDF/Adobe Acrobat - Versión en HTML
... productos IVD deben llevar el marcado CE. para poder ser comercializados ...
Directiva IVD. Nuestros productos. incorporarán el marcado CE en el momento ...
www.dakocytomation.es/ce-folleto.pdf - Páginas similares



Sonia López Grande
Spain
Local time: 22:10
Native speaker of: Native in SpanishSpanish, Native in GalicianGalician
PRO pts in category: 20
Grading comment
Graded automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Elena Sgarbo (X): :-))
6 mins
  -> gracias Elena

agree  Egmont
6 hrs
  -> gracias
Login to enter a peer comment (or grade)

19 mins   confidence: Answerer confidence 5/5 peer agreement (net): +1
CE-IVD


Explanation:
Hola,

"CE-IVD" es el sello europeo para kits de diagnóstico in vitro. La sigla queda igual.

CE= Communautes Europeennes
VD= In Vitro Diagnostics


The Directive on in vitro Diagnostic Medical Devices (IVDD 98/79/EC) was officially adopted by the European Union (EU) on December 7, 1998. The IVDD aims to supplement the legal framework of the European Community, which governs the conditions for the placing on the market of medical devices, by extending the already implemented legislation to the category of in ** vitro diagnostic medical devices (IVDs). ** They consist of those devices, including reagents and reagent products, calibrator materials or instruments, as well as specimen receptacles, intended by the manufacturer for the in vitro analysis of specimens derived from the human body. This directive has introduced at the European level common regulatory requirements across Europe for the safety, quality and performance of in vitro diagnostics (IVDs), incorporating them into medical device legislation. It harmonizes the conformity assessment procedures to be applied by manufacturers before they place IVDs on the market. For certain products expressly specified in the directive, of which the most important are used for the evaluation of the safety of blood supply and patient testing, the manufacturer will have to take into account in their performance evaluation the so-called "Common Technical Specifications" (CTS). These are needed to establish the performance characteristics of the IVDs in evaluation and have the same status as harmonized standards. In the meantime, the ** IVD ** directive has been transposed into national law in all EU countries. During a transitional period ending in December 2003, manufacturers will have the option of following pre-existing national regulatory processes or taking their IVDs through the new procedures as specified in the directive. Following this, starting from 7th December 2003, adherence to the directive regulations will become mandatory, and only IVDs bearing the ** "Communautes Europeennes (CE) mark" ** can then be sold in the EU.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d...


[PDF] Artisan Staining System Sistema de tinción Artisan Manual del sistema
Formato de archivo: PDF/Adobe Acrobat - Versión en HTML
... presentar el ** símbolo CE-IVD ** y no están disponibles en la actualidad para su comercialización en Europa para diagnósticos in vitro. ...

pri.dakocytomation.com/0000631_ rev_-_man_artisan_handbook_spanish.pdf

Elena Sgarbo (X)
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 12

Peer comments on this answer (and responses from the answerer)
agree  Egmont
6 hrs
  -> Gracias, Alberto
Login to enter a peer comment (or grade)



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