A number of legislative acts or regulatory documents in the area of health protection of the Russian Federation as the Constitution of the Russian Federation Federal Law № 5487-1 dated 22.07.1993 "Technical Regulation”; № 184- FL of 27.12.2002 "Federal Law On Fundamentals of Protection of Public Health in the Russian Federation”., of Ministry of Public Health and Social Development of the Russian Federation Order No 735, dated 30 October 2006 of Administrative regulation of the Federal service for supervision in the sphere of health and social development of performance of the state duty of registration of medical products, medical devices”, the act of Russian Ministry for Healthcare Order # 1353n dated 21.12.2012, “On approving the organization and conduct of expert appraisals on the quality, efficacy and safety of medical goods” pay a great attention to health protection in the registration of medical products, medical devices. According to this position the Biological evaluation of medical products, medical devices is a fundamental factor in the decision their possibility using in medicine.
медицинские изделия, безопасность, испытания, medical devices, safety, testing
1. GOST R 52770-2007 «Izdeliya medicinskie. Trebovaniya bezopasnosti. Metody sanitarno-himicheskih i toksikologicheskih ispytaniy».
2. Prikaz Ministerstva zdravoohraneniya i social'nogo razvitiya Rossiyskoy Federacii ot 30.10.2006 № 735 «Ob utverzhdenii Administrativnogo reglamenta Federal'noy sluzhby po nadzoru v sfere zdravoohraneniya i social'nogo razvitiya po ispolneniyu gosudarstvennoy funkcii po registracii izdeliy medicinskogo naznacheniya» (zaregistrirovano v Minyuste RF 30.11.2006 №8542)
3. Dokumenty, trebuemye dlya provedeniya tehnicheskih ispytaniy medicinskih izdeliy. [Elektronnyy resurs]. URL: http://www.roszdravnadzor.ru/i/upload/files/1165829953.91588-11931.
4. M.A. Ibragimov, Vestnik Kazanskogo tehnologicheskogo universiteta, 9, 119 - 126 (2012).
5. A. G. Liakumovich, A. P. Rahmatullina, M. A. Ibragimov, N. V. Galkina, D. G. Miloslavskiy, Vestnik Kazanskogo tehnologicheskogo universiteta, 20, 148 - 154 (2012).
