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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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07/06/2020 Cardiovascular 3-155 Complete 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
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
12/18/2023 Cardiovascular 3-126 Partial 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)]
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
07/06/2020 Cardiovascular 3-123 Partial 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
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
08/06/2013 Cardiovascular 3-115 Complete IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
12/18/2023 Cardiovascular 3-105 Partial 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
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
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