Denysenko A. Improvement of qualimetric methods of risk assessment while ensuring the quality of medical devices

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number


Applicant for


  • 05.01.02 - Стандартизація, сертифікація та метрологічне забезпечення


Specialized Academic Board

К 64.108.04

Ukrainian Engineering Pedagogics Academy


In the dissertation the actual scientifically applied problem in the field of an estimation of risks of products of medical appointment is solved and techniques of their estimation at production and operation stages are developed. Density functions of dimensionless estimations of indicators of quality of medical devices as functionally dependent statistics in case when their unit quality indicators are subordinated to the normal law of distribution at various parameters of form k are determined. The method of risk (probability) assessment of the quality of medical devices in the given "assessment interval" is proposed and the probabilities of transition between the intervals are determined. The laws of distribution of neodymium lasers reliability indicators are determined. The method of risk assessment in the manufacture of medical devices, which was developed based on the requirements of standards DSTU EN ISO 14971, DSTU EN ISO 13485, technical regulations on medical devices.


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