extractables and leachables

Romanian translation: substanţe extractibile şi produse de degradare

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:extractables and leachables
Romanian translation:substanţe extractibile şi produse de degradare
Entered by: Irina Zbravoz

19:32 Oct 5, 2011
English to Romanian translations [PRO]
Medical - Medical: Pharmaceuticals / biopharmacy
English term or phrase: extractables and leachables
extractables and leachables testing
Irina Zbravoz
Romania
Local time: 16:25
substanţe extractibile şi produse de degradare
Explanation:
Proiectarea studiilor toxicocinetice pentru produse de degradare şi substanţe extractibile.
http://freelex.juridic.ro/DocumentView.aspx?DocumentId=73913
SR EN ISO 10993-16:2003
Evaluarea biologică a dispozitivelor medicale.
Partea 16: Proiectarea studiilor toxicocinetice pentru produse
de degradare şi substanţe extractibile
Înlocuit prin: SR EN ISO 10993-16:2009
http://www.asro.ro/romana/publicatii/Buletin 2010/Buletin Ma...
Selected response from:

Claudia Coja
Local time: 15:25
Grading comment
multumesc Claudia!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1substanţe extractibile şi produse de degradare
Claudia Coja
Summary of reference entries provided
extractables and leachables
Claudia Coja

  

Answers


2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
substanţe extractibile şi produse de degradare


Explanation:
Proiectarea studiilor toxicocinetice pentru produse de degradare şi substanţe extractibile.
http://freelex.juridic.ro/DocumentView.aspx?DocumentId=73913
SR EN ISO 10993-16:2003
Evaluarea biologică a dispozitivelor medicale.
Partea 16: Proiectarea studiilor toxicocinetice pentru produse
de degradare şi substanţe extractibile
Înlocuit prin: SR EN ISO 10993-16:2009
http://www.asro.ro/romana/publicatii/Buletin 2010/Buletin Ma...

Claudia Coja
Local time: 15:25
Works in field
Native speaker of: Native in RomanianRomanian
PRO pts in category: 55
Grading comment
multumesc Claudia!
Notes to answerer
Asker: exact pentru SGS trebuia sa traducș eu gasisem si termenul "lixiviabil", insa nu eram sigura.


Peer comments on this answer (and responses from the answerer)
agree  George C.
7 hrs
  -> Multumesc:)
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Reference comments


2 hrs peer agreement (net): +1
Reference: extractables and leachables

Reference information:
􀂄 Extractable: Any chemical species that can be
removed from a packaging component under abusive
laboratory conditions
􀂄 Leachable: an extractable that actually migrates into a
drug product under storage conditions
http://www.us.sgs.com/cvg100506.pdf

Claudia Coja
Works in field
Native speaker of: Native in RomanianRomanian
PRO pts in category: 55

Peer comments on this reference comment (and responses from the reference poster)
agree  Cristina Crişan: Cred că se traduc ambele prin extractibile -Toxicokinetic study design for degradation products and leachables http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2...
10 hrs
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