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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
08/06/2013 Cardiovascular 3-87 Complete ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
08/20/2012 Cardiovascular 3-104 Complete ASTM F2914-12 (Reapproved 2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
04/04/2016 Cardiovascular 3-125 Complete ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
01/14/2019 Cardiovascular 3-66 Complete ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
09/17/2018 Cardiovascular 3-110 Complete AAMI TIR 41:2011/(R)2017 Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
01/25/2013 Cardiovascular 3-89 Complete 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
ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
08/20/2012 Cardiovascular 3-103 Complete ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
09/17/2018 Cardiovascular 3-153 Complete ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
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