Oct 3, 2019 15:49
4 yrs ago
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English term
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Native in: Russian 
, Latvian
Works in: English to Russian, Russian to English, Latvian to Russian, and 3 more.
design dossier/type examination dossier
English to Russian
Medical
Medical (general)
medical devices directive
MEDDEV 2.7/1 rev.4
A.12.2 Examination of a design dossier or of a type examination dossier
thanks in advance!
A.12.2 Examination of a design dossier or of a type examination dossier
thanks in advance!
Proposed translations
(Russian)
| 3 | досье дизайна/досье типа исследования |
harser
|
| 4 | комплект конструкторской документации/ экспертиза типа медицинских изделий |
hawkwind
|
Proposed translations
3 hrs
Selected
досье дизайна/досье типа исследования
-
4 KudoZ points awarded for this answer.
Comment: "Thank you!"
23 hrs
комплект конструкторской документации/ экспертиза типа медицинских изделий
http://www.doks.nbog.eu/Doks/NBOG_BPG_2009_1.pdf
the Medical Devices Directive 93/42/EEC section 4 of Annex II and section 4 of Annex
III (design dossier related part of type-testing examination)
http://www.icqc.eu/userfiles/File/directive 93 42 eec medica...
4. Экспертиза конструкции изделия
4.1 В дополнении к требования, предусмотренным в Разделе 3, изготовитель обязан
подавать в нотифицированный орган заявку на проведение экспертизы конструкторской документации,
относящейся к изделию, изготавливать которое он планирует, и которое относится к категории,
упомянутой в Разделе 3.1.
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSL...
4. Examination of the design of the product
4.1. In addition to the obligations imposed by Section 3, the manufacturer must
lodge with the notified body an application for examination of the design
dossier relating to the product which he plans to manufacture and which
falls into the category referred to in Section 3.1.
https://www.emergobyul.com/services/europe/technical-file-pr...
https://www.curamedical.com/files/2018/08/CuraSpon-powder-EC...
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Note added at 23 hrs (2019-10-04 14:56:07 GMT)
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поправка .../ досье экспертизы типа...
the Medical Devices Directive 93/42/EEC section 4 of Annex II and section 4 of Annex
III (design dossier related part of type-testing examination)
http://www.icqc.eu/userfiles/File/directive 93 42 eec medica...
4. Экспертиза конструкции изделия
4.1 В дополнении к требования, предусмотренным в Разделе 3, изготовитель обязан
подавать в нотифицированный орган заявку на проведение экспертизы конструкторской документации,
относящейся к изделию, изготавливать которое он планирует, и которое относится к категории,
упомянутой в Разделе 3.1.
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSL...
4. Examination of the design of the product
4.1. In addition to the obligations imposed by Section 3, the manufacturer must
lodge with the notified body an application for examination of the design
dossier relating to the product which he plans to manufacture and which
falls into the category referred to in Section 3.1.
https://www.emergobyul.com/services/europe/technical-file-pr...
https://www.curamedical.com/files/2018/08/CuraSpon-powder-EC...
--------------------------------------------------
Note added at 23 hrs (2019-10-04 14:56:07 GMT)
--------------------------------------------------
поправка .../ досье экспертизы типа...
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