Tag: BS EN ISO 25539-2

Corrections issued in latest edition of BS EN ISO 25539-2, Cardiovascular implants – Endovascular devices – Vascular stents

BS EN ISO 25539-2:2009 has been corrected with the addition of a new 2012 Corrigendum.  The standard, “Cardiovascular implants. Endovascular devices. Vascular stents,” is modified by corrections to the National Forward.  Like all British Standards, it is available now from Document Center Inc.

This British Standard is the UK implementation of EN ISO 25539-2:2009, incorporating the corrigendum from February 2011. It is identical to ISO 25539-2:2008.  And it supersedes BS EN ISO 25539-2:2008, which is now obsolete.

Together with BS EN ISO 25539-1:2009, BS EN ISO 25539-2 supersedes BS EN 14299:2004, which is withdrawn.  And along with BS EN ISO 25539-1:2009 and BS EN ISO 25539-3:2011, it replaces BS EN 12006-3:1998+A1:2009, which is also withdrawn.

You’ll notice that the adopted ISO standard has not changed, even though the BS EN ISO 25539-2:2009 has been reissued twice with corrections.  This is because the corrections center on the administrative adoption and implementation process, not on the technical information in the standard itself.

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Medical Device Standards – The Top 10 Standards on Vascular Stents

Vascular stents are the tubes that are placed in blood vessels to improve the flow of blood, either by preventing or counteracting a localized flow constriction.  Standards for those stents have been in force since the beginning of the 21st century.  Here are our top ten standards on the subject:

ASTM-F2079, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM-F2081, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM-F2394, Standard Guide for Measuring  Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM-F2477, Standard Test Method for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM-F2514, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM-F2606, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

ANSI/AAMI/ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

BS-EN-ISO-25539-2, Cardiovascular Implants – Endovascular Devices –  Vascular Stents

All of the above standards can be purchased from Document Center Inc.  Buy them at www.document-center.com, or phone 650-591-7600, fax 650-591-7617, or email info@document-center.com.