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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/26/2025 Neurology 17-20 Complete IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
05/26/2025 Neurology 17-22 Complete IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
05/26/2025 Radiology 12-380 Complete IEC 60601-2-37 Edition 3.0 2024-07 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
05/26/2025 Radiology 12-381 Complete IEC 60601-2-68 Edition 2.0 2025-02 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
12/22/2025 Anesthesiology 1-199 Complete ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/22/2025 Biocompatibility 2-311 Complete ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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
12/22/2025 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
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