Features of toxicology tests of medical devices within the national legislation of the Russian Federation

Kargin Ivan; Novikova Margarita Aleksandrovna; Tarasenko Ol'ga Anatol'evna

doi:doi:10.35576/article_5d135f4a38ba93.84633878

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Features of toxicology tests of medical devices within the national legislation of the Russian Federation

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FEATURES OF TOXICOLOGY TESTS OF MEDICAL DEVICES WITHIN THE NATIONAL LEGISLATION OF THE RUSSIAN FEDERATION

Journal: VESTNIK ROSZDRAVNADZORA Volume 2019 № 3 , 2019

Rubrics: THE CIRCULATION OF MEDICAL DEVICES: RUSSIAN AND FOREIGN PRACTICE

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

Author and publication information

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'.

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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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