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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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09/17/2018 General II (ES/
EMC)		 19-19 Partial IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 Complete IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 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
01/14/2019 Anesthesiology 1-138 Complete ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
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