STATE CONTROL OF CIRCULATION OF MEDICAL DEVICES. TYPICAL VIOLATIONS DETECTED BY TOXICITY STUDIES OF MEDICAL DEVICES
Rubrics: MEDICINE AND HEALTHCARE
Authors:
1.
FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE
, Russian Federation
, Russian Federation
2.
Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.
( General'nyy direktor)
3.
Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.
4.
Federal State budgetary Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service on surveillance in healthcare.
, Russian Federation
, Russian Federation
Type:
Article
Pages:
from 22
to 31
Status:
Published
Received:
22.10.2019
Accepted:
22.11.2019
Published:
22.11.2019
Subject area:
UDK 61 Медицина. Охрана здоровья
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
Language:
Russian
Keywords:
medical device, state control of circulation of medical devices, toxicity studies, safety of medical device, quality of medical device
Abstract (English):
This article dedicated to the issues of state control over circulation of medical devices and typical violations detected by toxicity studies of medical devices. The article reviews the typical violations of mandatory requirements for various subjects of circulation of medical devices. The article specifically covers the reasons for decline of toxicological and sanitary chemical indicators when conducting toxicity studies of medical devices in the framework of state control.
This article dedicated to the issues of state control over circulation of medical devices and typical violations detected by toxicity studies of medical devices. The article reviews the typical violations of mandatory requirements for various subjects of circulation of medical devices. The article specifically covers the reasons for decline of toxicological and sanitary chemical indicators when conducting toxicity studies of medical devices in the framework of state control.
Keywords:
medical device, state control of circulation of medical devices, toxicity studies, safety of medical device, quality of medical device
medical device, state control of circulation of medical devices, toxicity studies, safety of medical device, quality of medical device
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2. Reznichenko S.V., Morozov Yu.L. (red.) Bol'shoy spravochnik rezinschika. Tom 1. Kauchuki i ingredienty. M.: Tehinform, 2012. – 460 s.
