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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/06/2020 Anesthesiology 1-146 ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
07/06/2020 Biocompatibility 2-273 ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/06/2020 Biocompatibility 2-274 ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/06/2020 Biocompatibility 2-275 ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2020)]
07/06/2020 Biocompatibility 2-276 ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
07/06/2020 Cardiovascular 3-123 ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type 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
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
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
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
07/06/2020 Cardiovascular 3-164 ASTM F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
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