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Home / Journals / Vestnik Roszdravnadzora / Volume 2019 Issue 3 / Features of toxicology tests of medical devices within the national legislation of the Russian Federation
Features of toxicology tests of medical devices within the national legislation of the Russian Federation
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Citations:

FEATURES OF TOXICOLOGY TESTS OF MEDICAL DEVICES WITHIN THE NATIONAL LEGISLATION OF THE RUSSIAN FEDERATION
UDK 61 Медицина. Охрана здоровья GRNTI 76.35 Прочие отрасли медицины и здравоохранения
Kargin Ivan 1
Novikova Margarita Aleksandrovna 2
Tarasenko Ol'ga Anatol'evna 3
Authors:
1.  Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.

, Russian Federation
2.  Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.

3.  Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.

Type:
Article
DOI:
https://doi.org/10.35576/article_5d135f4a38ba93.84633878
Pages:
from 31 to 35
Status:
Published
Received:
25.06.2019
Accepted:
26.06.2019
Published:
26.06.2019
Subject area:
UDK 61 Медицина. Охрана здоровья
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
Language:
Russian
Keywords:
medical devices (MD), testing laboratory, Applicant, toxicology test, safety of medical device, quality of medical device, conformity assessment
Abstract and keywords
Abstract (English):
The procedure and the rules of toxicology testing of medical devices (MD) for the purpose of their registration in the framework of the national legislation of the Russian Federation are discussed.

Keywords:
medical devices (MD), testing laboratory, Applicant, toxicology test, safety of medical device, quality of medical device, conformity assessment
References

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2. Postanovlenie Pravitel'stva Rossiyskoy Federacii ot 27.12.2012 № 1416 «Ob utverzhdenii Pravil gosudarstvennoy registracii medicinskih izdeliy».

3. GOST R 52770-2016 Izdeliya medicinskie. Trebovaniya bezopasnosti. Metody sanitarno-himicheskih i toksikologicheskih ispytaniy.

4. GOST 31214-2016 Izdeliya medicinskie. Trebovaniya k obrazcam i dokumentacii, predstavlyaemym na toksikologicheskie, sanitarno-himicheskie issledovaniya, ispytaniya na steril'nost' i pirogennost'.

5. Prikaz Minzdrava Rossii ot 09.01.2014 № 2n «Ob utverzhdenii Poryadka provedeniya ocenki sootvetstviya medicinskih izdeliy v forme tehnicheskih ispytaniy, toksikologicheskih issledovaniy,klinicheskih ispytaniy v celyah gosudarstvennoy registracii medicinskih izdeliy».

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7. GOST ISO/MEK 17025-2009 Obschie trebovaniya k kompetentnosti ispytatel'nyh i kalibrovochnyh laboratoriy.

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9. Prikaz Minzdrava Rossii ot 19.01.2017 № 11n «Ob utverzhdenii trebovaniy k soderzhaniyu tehnicheskoy i ekspluatacionnoy dokumentacii proizvoditelya (izgotovitelya) medicinskogo izdeliya».

10. Prikaz Minzdrava Rossii ot 15.06.2012 № 7n «Ob utverzhdenii Poryadka vvoza na territoriyu Rossiyskoy Federacii medicinskih izdeliy v celyah gosudarstvennoy registracii».

11. GOST ISO 10993-1-2011 Izdeliya medicinskie. Ocenka biologicheskogo deystviya medicinskih izdeliy. Chast' 1. Ocenka i issledovaniya.

12. GOST ISO 10993-12-2015 Izdeliya medicinskie. Ocenka biologicheskogo deystviya medicinskih izdeliy. Chast' 12. Prigotovlenie prob i kontrol'nye obrazcy.

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