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U.S. Department of Health and Human Services

Recognized Consensus Standards

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06/07/2018 Cardiovascular 3-150 ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
07/06/2020 Cardiovascular 3-152 ANSI AAMI IEC 80601-2-30:2009 & A1:2013 (R2016) 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 1.1 2013-07 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
09/17/2018 Cardiovascular 3-153 ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018 Cardiovascular 3-154 ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
07/06/2020 Cardiovascular 3-155 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
IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
09/17/2018 Cardiovascular 3-156 ISO 14708-1 Second edition 2014-08-15 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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
01/14/2019 Cardiovascular 3-159 ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
07/06/2020 Cardiovascular 3-160 ANSI AAMI ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
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