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STC

English translation: Spécifications Techniques Communes = Common Technical Specifications (CTSs)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:STC
English translation:Spécifications Techniques Communes = Common Technical Specifications (CTSs)
Entered by: Drmanu49
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07:49 Sep 22, 2007
French to English translations [PRO]
Medical - Medical (general) / ETUDE DE DISPOSITIFS MEDx.
French term or phrase: STC
à tester l'exactitude des réactifs et la conformité de la limite de détection annoncée à l’aide de gammes de dilution du standard international (en milieu sérique et plasmatique) compte-tenu de l'existence de //STC//
xxx::::::::::
Iraq
Local time: 09:02
Spécifications Techniques Communes = Common Technical Specifications (CTSs)
Explanation:
In a similar manner, compliance with the Common Technical Specifications (CTSs) for the most critical IVDs (those listed in Annex II, ...
www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=2... - 31k -
Selected response from:

Drmanu49
France
Local time: 09:02
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3CTS (common technical specifications)
Andrés Martínez
4Spécifications Techniques Communes = Common Technical Specifications (CTSs)
Drmanu49


Discussion entries: 1





  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
CTS (common technical specifications)


Explanation:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:...
2002/364/CE: Décision de la Commission du 7 mai 2002 portant spécifications techniques communes des dispositifs médicaux de diagnostic in vitro (Texte présentant de l'intérêt pour l'EEE) [notifiée sous le numéro C(2002) 1344]

Journal officiel n° L 131 du 16/05/2002 p. 0017 - 0030
(...)
Sensibilité analytique

Aux fins de l'application des ***spécifications techniques communes (STC)***, on entend par "sensibilité analytique" la limite de détection, soit la plus petite quantité de marqueur cible pouvant être détectée avec précision.


http://agmed.sante.gouv.fr/htm/10/dm/sdm/rapport_vih_double_...

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2002/l_131/l_...

Official Journal of the European Communities

COMMISSION DECISION of 7 May 2002 on ***common technical specifications*** for in vitro-diagnostic medical devices (notified under document number C(2002) 1344)
(Text with EEA relevance)
(2002/364/EC)

ANNEX
***CTS — COMMON TECHNICAL SPECIFICATIONS *** FOR IN VITRO-DIAGNOSTIC MEDICAL DEVICES

--------------------------------------------------
Note added at 1 hr (2007-09-22 09:04:02 GMT)
--------------------------------------------------

http://agmed.sante.gouv.fr/htm/10/dm/sdm/rapport_controle_do...
RAPPORT DU CONTROLE DE MARCHE DES DISPOSITIFS MEDICAUX DE DIAGNOSTIC IN VITRO POUR LA DETECTION ET LE DOSAGE
DES ANTICORPS ANTI-HBs
(...)
II Méthodologie
(...)
Les objectifs du groupe sont d’une part, d’étudier le comportement des réactifs en terme de reconnaissance de différents échantillons à l’aide d’un panel donné avec comme référentiel les ***Spécifications Techniques Communes (STC) *** Européennes (au minimum 98 % de sensibilité et de spécificité) et d’autre part, de tester l’exactitude de ces réactifs ainsi que la conformité de la limite de détection annoncée dans la notice comptetenu de l’existence de ***STC ***(la sensibilité doit être au minimum de 10 UI/l).


Andrés Martínez
Spain
Local time: 09:02
Specializes in field
Native speaker of: Spanish
PRO pts in category: 20

Peer comments on this answer (and responses from the answerer)
agree  Mihaela Petrican
1 hr
  -> Thank you, Mihaela.

agree  liz askew: CTSs. Well-researched!
8 hrs
  -> Thanks very much, Liz.

agree  Dr Sue Levy: over 400 ghits for "common technical specifications" + CTS, only 19 for CTSs (rather unusual to add a small s to indicate plural in an acronym)
1 day10 hrs
  -> Thanks very much, Sue.
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Spécifications Techniques Communes = Common Technical Specifications (CTSs)


Explanation:
In a similar manner, compliance with the Common Technical Specifications (CTSs) for the most critical IVDs (those listed in Annex II, ...
www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=2... - 31k -

Drmanu49
France
Local time: 09:02
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 3989

Peer comments on this answer (and responses from the answerer)
neutral  Dr Sue Levy: isn't this the same as Urico's answer?//maybe you were too fast and flooded the system lol
1 day8 hrs
  -> That's me, the floody Manu! What puzzles me is that I answered almost immediately and that I am marked 2H??? In any case, if his answer was actually first, I have no problem with giving him the points.
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Changes made by editors
Sep 23, 2007 - Changes made by Drmanu49:
Edited KOG entry<a href="/profile/117699">xxx::::::::::'s</a> old entry - "STC" » "Spécifications Techniques Communes = Common Technical Specifications (CTSs)"


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