Glossary entry

English term or phrase:

full scope of designation

Romanian translation:

suntem desemnati/nominalizati pentru gama completa de produse conform Directivei

Added to glossary by Laura Genescu (Briciu)
Nov 7, 2011 15:08
12 yrs ago
29 viewers *
English term

full scope of designation

English to Romanian Other Law (general)
We have a full scope of designation under the directive, i.e. all List A, List B and Self-Test IVD devices.
Change log

Nov 8, 2011 06:35: tagore changed "Field (specific)" from "Science (general)" to "Law (general)"

Discussion

Cristina Crişan Nov 8, 2011:
SGS is pleased to announce that it has extended its Notified Body scope under the European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices to include high risk LIST A products, giving a full designation scope. SGS initially gained designation as IVD medical device Directive (IVDD) Notified Body 0120 in 2010, with a scope that included all LIST B and Self-Test IVD devices. This extension to the designated scope means that SGS Notified Body can additionally provide certification services for all LIST A devices. SGS now has a global comprehensive scope for all manufacturers of IVD devices.
http://www.medicaldevices.sgs.com/news/sgs-achieves-a-full-i...
Laura Genescu (Briciu) (asker) Nov 7, 2011:
din pacate acesta este singurul context pe care il am ..
Laura Genescu (Briciu) (asker) Nov 7, 2011:
xxxxx is Notified Body 0120 under directive 98/79/EC.
Laura Genescu (Briciu) (asker) Nov 7, 2011:
intrebarea nu este din domeniul juridic ci contextul mai larg este din domeniul certificari ISO- Medical devices utilizing certain tissues of animal origin (...)
Eu sunt de parere ca intrebarea ar trebui reincadrata la domeniul juridic.

Proposed translations

+1
1 day 2 hrs
Selected

suntem desemnati/nominalizati pentru gama completa de produse conform Directivei

Din link-ul de mai jos se poate vedea ca in acest context " scope" acopera o gama de produse, desi, asa cum bine afirma Florin, "scope" nu inseamna "gama".
De fapt, este vorba despre desemnarea ca organism competent pentru evaluarea unei game complete de instrumente medicale.


2009-3 Guideline for Designating Authorities to Define the ...


www.nbog.eu/resources/NBOG_BPG_2009_3.pdf


File Format: PDF/Adobe Acrobat - Quick View
Page 1 of 7. Guideline for Designating Authorities to Define the. Notification Scope of a Notified Body Conducting Medical. Devices Assessments. 1 Introduction ...
Peer comment(s):

agree Iosif JUHASZ
10 days
Multumesc frumos
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4 KudoZ points awarded for this answer. Comment: "Multumesc mult de tot pentru ajutor!!"
-3
45 mins

Gamă completă de indicatoare

... sau inscripţii.

Ne-ar ajuta mai mult un context mai bine definit, totusi. Nu inteleg exact la ce se refera aceste designations, ce denumesc ele.
Peer comment(s):

disagree Florin Ular : „scope” nu este „gamă” iar „designation” nu sunt „indicatoare”.
1 hr
disagree Marian Popa (X) : sorry
5 hrs
disagree Maria Macovei : iata si link-ul unde cred ca apare fraza completa + explicatiile de rigoare in josul paginii.
1 day 7 hrs
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6 hrs

Desemnare [nominalizare] in exclusivitate

Se refera la faptul ca subsemnatul a primit nominalizarea exclusiva, sau desemnarea in intregime, ca sa traduc mot-a-mot. Prin "intregime" aici se intelege ca numeni altcineva nu a mai fost nominalizat priving nici un alta aspect, deci se poate intelege existenta "exclusivitatii."
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16 hrs

întreaga sferă....

Organism desemnat să certifice întreaga sferă a produselor/serviciilor la care face referire directiva
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Reference comments

40 mins
Reference:

poate "suntem autorizati sub incidenta directivei"?

Am inteles in mare despre ce e vorba, dar nu reusesc sa gasesc o exprimare care sa sune bine.
Sper sa va ajute link-ul de mai jos si intre timp mai caut.
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