Standard

NEN-ISO 5910:2018 en

Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices

181,14 219,18 Incl BTW

About norm

Status Current
Number of pages 126
Committee Chirurgische implantaten
Published on 01-06-2018
Language English
NEN-ISO 5910 applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus). This document outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological, and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system.

Details

ICS-code 11.040.40
English title Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices

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