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  • BSI
    BS ISO 5910:2018 Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices
    Edition: 2018
    $569.57
    / user per year

Description of BS ISO 5910:2018 2018

1.1

This document 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).

1.2

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.

NOTE For the purposes of this document, effectiveness endpoint includes clinical performance and benefits.

1.3

This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification.

1.4

This document excludes Cardiac Resynchronization Therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This Standard also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice).

NOTE A rationale for the provisions of this document is given in Annex A.



Standard NumberBS ISO 5910:2018
TitleCardiovascular implants and extracorporeal systems. Cardiac valve repair devices
StatusWithdrawn
Publication Date2018-06-05
Withdrawn Date2024-07-17
Identical National Standard OfISO 5910:2018
DescriptorsSurgery, Blood transfusion equipment, Circulatory system, Artificial organs, Performance, Blood, Blood vessels, Medical equipment, Surgical equipment, Sterile equipment, Instructions for use, Heart, Filters, Cardiology
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 87618 9
PublisherBSI
Pages136

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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