EU MDR limit

Russian translation: предельное значение, установленное Регламентом ЕС о медицинских изделиях

16:18 May 25, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / исследование
English term or phrase: EU MDR limit
although the formulation contains boric acid which has been classified as GHS Category 1B (presumed human reproductive toxicant) at a level above the EU MDR limit of 0.1% in a medical device product (EU Medical Device Regulation, Annex I; May 2017), a comprehensive assessment has been conducted and, based on the low actual exposure to the patient, concluded that the benefits of including boric acid in the formulation far outweigh the negligible risks
Olesya Poleschuk
Kazakhstan
Local time: 18:53
Russian translation:предельное значение, установленное Регламентом ЕС о медицинских изделиях
Explanation:
EU MDR = European Union Medical Device Regulation
Selected response from:

Tetiana Tkachenko
Ukraine
Local time: 16:53
Grading comment
3 KudoZ points were awarded for this answer



Summary of answers provided
4 +2предельное значение, установленное Регламентом ЕС о медицинских изделиях
Tetiana Tkachenko
4допустимое содержание (предельное значение) в соответствии с регламентом ЕС о медицинских изделиях
Stanislav Korobov


  

Answers


21 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
eu mdr limit
предельное значение, установленное Регламентом ЕС о медицинских изделиях


Explanation:
EU MDR = European Union Medical Device Regulation


    Reference: http://eumdr.com/
    https://www.sgs-caspian.com/ru-ru/life-sciences/medical-devices/regulatory-certification/european-medical-devices-regulation-mdr-eu-2017-745
Tetiana Tkachenko
Ukraine
Local time: 16:53
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 23

Peer comments on this answer (and responses from the answerer)
agree  Stanislav Korobov
1 min

agree  Natalie
1 day 18 hrs
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22 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
допустимое содержание (предельное значение) в соответствии с регламентом ЕС о медицинских изделиях


Explanation:


Stanislav Korobov
Ukraine
Local time: 16:53
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1216
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