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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/22/2025 Cardiovascular 3-203 Partial IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
12/22/2025 Cardiovascular 3-202 Complete IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
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
12/22/2025 Cardiovascular 3-201 Complete IEC 60601-2-31 Edition 3.0 2020-01 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
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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