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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
01/14/2019 Cardiovascular 3-79 ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
01/14/2019 Cardiovascular 3-86 ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
08/06/2013 Cardiovascular 3-87 ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
01/27/2015 Cardiovascular 3-88 ASTM F2514-08 (Reapproved 2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial
01/25/2013 Cardiovascular 3-89 ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/30/2014 Cardiovascular 3-92 ANSI AAMI ISO 14708-5:2010 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
ISO 14708-5 First edition 2010-02-01 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
03/16/2012 Cardiovascular 3-96 ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
10/22/2018 Cardiovascular 3-99 AAMI TIR 42:2010 Evaluation of Particulates Associated with Vascular Medical Devices
08/20/2012 Cardiovascular 3-102 IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/20/2012 Cardiovascular 3-103 ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
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