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BSI - BS EN ISO 25539-2

Cardiovascular implants - Endovascular devices Part 2: Vascular stents

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Organization: BSI
Publication Date: 31 October 2020
Status: active
Page Count: 126
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN ISO 25539-2
October 31, 2020
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
A description is not available for this item.
BS EN ISO 25539-2
January 31, 2013
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
A description is not available for this item.
BS EN ISO 25539-2
February 28, 2010
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
A description is not available for this item.
BS EN ISO 25539-2
February 28, 2010
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes,...
BS EN ISO 25539-2
February 28, 2010
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
A description is not available for this item.
BS EN ISO 25539-2
September 30, 2009
Cardiovascular implants - Endovascular devices Part 2: Vascular stents
A description is not available for this item.
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References

This document references:
ASTM F2514 - Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
Published by ASTM on July 15, 2008
Purpose—This guide establishes general requirements and considerations for the development of finite element models used in the evaluation of the performance of a metallic vascular stent design under...
This document references:
ASTM F2743 - Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Published by ASTM on October 1, 2011
This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent...
This document references:
F2914 - Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
January 15, 2012
This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug...
This document references:
ASTM F3067 - Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
Published by ASTM on October 15, 2014
This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of...
This document references:
ASTM F3172 - Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
Published by ASTM on December 15, 2015
This guide provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular...
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