Abstract
The purpose of this report is to present an update of technical requirements for heart valve prostheses including newly developed prostheses. The comparative analysis of the requirements of both the ISO 5840:2005 (E) and a new version of National Russian Standard GOST R 52999.1: «Cardiac valve prostheses. Part 1. General technical requirements and test methods» has been done. The necessity of obtaining the objective assessment of efficacy and safety of newly developed and serially produced heart valve prostheses was taken into consideration for the old Standard GOST 26997-2003 to be reviewed mostly with regard to the prosthesis technical requirements, test methods and test results evaluation.
References
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