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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
06/07/2018 Radiology 12-316 Complete IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
07/09/2014 InVitro Diagnostics 7-221 Complete CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
08/21/2017 General Plastic Surgery/
General Hospital		 6-384 Complete ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
01/14/2019 Neurology 17-14 Complete ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
08/21/2017 Anesthesiology 1-127 Complete ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
12/23/2016 Anesthesiology 1-119 Complete ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
01/30/2014 Cardiovascular 3-118 Complete ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
01/14/2019 Orthopedic 11-347 Complete ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
08/21/2017 General II (ES/
EMC)		 19-22 Complete AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
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