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U.S. Department of Health and Human Services

Recognized Consensus Standards

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06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
08/06/2013 Cardiovascular 3-115 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
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-119 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
06/27/2016 Radiology 12-293 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
06/07/2018 Radiology 12-308 IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
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