LEGISLATIVE AND STANDARD AND METHODICAL BASE OF THE STANDARDIZATION, ASSESSMENT OF THE COMPLIANCE AND ACCREDITATION IN AREAS OF MEDICAL PRODUCTS
Valeriya A. Ivanova , A. A Chesnokova , E. O Shamina
Medical and Social Expert Evaluation and Rehabilitation ›› 2017, Vol. 20 ›› Issue (2) : 89 -94.
LEGISLATIVE AND STANDARD AND METHODICAL BASE OF THE STANDARDIZATION, ASSESSMENT OF THE COMPLIANCE AND ACCREDITATION IN AREAS OF MEDICAL PRODUCTS
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.
medical products / standardization / certification / accreditation of testing laboratories / standard and methodical base
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