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U.S. Department of Health and Human Services

Recognized Consensus Standards

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06/15/2016 Cardiovascular 3-132 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
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
04/04/2016 Cardiovascular 3-133 ANSI AAMI ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5840-3 First edition 2013-03-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
07/15/2019 Cardiovascular 3-137 ASTM F3036-13 Standard Guide for Testing Absorbable Stents
01/14/2019 Cardiovascular 3-138 ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
01/14/2019 Cardiovascular 3-142 ISO /TS 17137 First edition 2014-05-15 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants.
06/27/2016 Cardiovascular 3-143 ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
12/23/2016 Cardiovascular 3-144 ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
12/23/2016 Cardiovascular 3-145 ANSI AAMI ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
ISO 5840-1 First edition 2015-09-15 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
12/23/2016 Cardiovascular 3-147 ANSI AAMI ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
ISO 5840-2:2015 First Edition Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
08/21/2017 Cardiovascular 3-149 ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
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