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Glossary entry

French term or phrase:

STC

English translation:

Spécifications Techniques Communes = Common Technical Specifications (CTSs)

Added to glossary by Drmanu49
Sep 22, 2007 07:49
17 yrs ago
7 viewers *
French term

STC

French to English Medical Medical (general) ETUDE DE DISPOSITIFS MEDx.
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//
Proposed translations (English)
4 Spécifications Techniques Communes = Common Technical Specifications (CTSs)
4 +3 CTS (common technical specifications)
Change log

Sep 23, 2007 09:09: Drmanu49 changed "Edited KOG entry" from "<a href="/profile/117699">:::::::::: (X)'s</a> old entry - "STC"" to ""Spécifications Techniques Communes = Common Technical Specifications (CTSs)""

Discussion

Drmanu49 Sep 23, 2007:
Daniel, I just noted, thanks to Sue that I am marked 2h!
Having answered almost immediately (as usual) I did'nt check the time.
If you want to give Urico the points, it's fine with me if his answer actually came first.

Proposed translations

2 hrs
Selected

Spécifications Techniques Communes = Common Technical Specifications (CTSs)

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 -
Peer comment(s):
neutral Dr Sue Levy (X) : isn't this the same as Urico's answer?//maybe you were too fast and flooded the system lol
1 day 8 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.
Something went wrong...
4 KudoZ points awarded for this answer.
+3
1 hr

CTS (common technical specifications)


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).
Peer comment(s):
agree Mihaela Petrican
1 hr
Thank you, Mihaela.
agree liz askew : CTSs. Well-researched!
8 hrs
Thanks very much, Liz.
agree Dr Sue Levy (X) : 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 day 10 hrs
Thanks very much, Sue.
Something went wrong...