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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
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Standard Designation
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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
01/14/2019 Cardiovascular 3-122 ANSI AAMI ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
01/14/2019 Cardiovascular 3-123 ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment --Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-30 Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
01/14/2019 Cardiovascular 3-126 ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
01/14/2019 Cardiovascular 3-127 ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
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.
01/14/2019 Cardiovascular 3-157 ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/14/2019 Cardiovascular 3-158 ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
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