Open AccessLEGISLATIVE AND STANDARD AND METHODICAL BASE OF THE STANDARDIZATION, ASSESSMENT OF THE COMPLIANCE AND ACCREDITATION IN AREAS OF MEDICAL PRODUCTS
Author(s) -
В. А. Иванова,
Иванова Валерия Анатольевна,
A. A. Chesnokova,
Чеснокова А. А,
E. O. Shamina,
Шамина Е. О
Publication year - 2017
Publication title -
mediko-socialʹnaâ èkspertisa i reabilitaciâ/mediko-socialʹnaâ èkspertiza i reabilitaciâ
Language(s) - English
Resource type - Journals
eISSN - 2412-2092
pISSN - 1560-9537
DOI - 10.18821/1560-9537-2017-20-2-89-94
Subject(s) - accreditation , standardization , documentation , certification , compliance (psychology) , conformity assessment , certification and accreditation , legislature , field (mathematics) , business , accounting , engineering management , medicine , engineering , medical education , computer science , political science , operations management , law , psychology , social psychology , mathematics , pure mathematics , programming language
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.