Email this article LEGISLATIVE AND STANDARD AND METHODICAL BASE OF THE STANDARDIZATION, ASSESSMENT OF THE COMPLIANCE AND ACCREDITATION IN AREAS OF MEDICAL PRODUCTS
- Authors: Ivanova V.A.1, Chesnokova A.A1, Shamina E.O1
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Affiliations:
- Yaroslavl State Technical University
- Issue: Vol 20, No 2 (2017)
- Pages: 89-94
- Section: Articles
- URL: https://ogarev-online.ru/1560-9537/article/view/35944
- DOI: https://doi.org/10.18821/1560-9537-2017-20-2-89-94
- ID: 35944
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Abstract
The standard and methodical documents regulating activity in the field of standardization, estimates of compliance, accreditation of bodies for a compliance assessment in the field of medical products are submitted. The list of participants of works and documents in the field of standardization of medical products is provided, forms of an assessment of compliance of medical products - certification, compliance declaring, the state registration, technical tests are characterized. Requirements to contents of necessary documentation and an order of accreditation of testing laboratories in the field of medical products are established.
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##article.viewOnOriginalSite##About the authors
Valeriya A. Ivanova
Yaroslavl State Technical University
Email: ivanova-waleriya@mail.ru
MD, PhD, Associate Professor, Head of the Department of the Technology of Materials, Standardization and Metrology; Yaroslavl, 150023, Russian Federation Yaroslavl, 150023, Russian Federation
A. A Chesnokova
Yaroslavl State Technical UniversityYaroslavl, 150023, Russian Federation
E. O Shamina
Yaroslavl State Technical UniversityYaroslavl, 150023, Russian Federation
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