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U.S. Department of Health and Human Services

Recognized Consensus Standards

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06/07/2021 General Plastic Surgery/
General Hospital
6-463 IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
01/14/2014 Radiology 12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
08/20/2012 Anesthesiology 1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
01/25/2013 Cardiovascular 3-105 ANSI AAMI IEC 60601-2-25:2011/(R)2016 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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)]
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