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U.S. Department of Health and Human Services

Recognized Consensus Standards

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12/23/2019 Radiology 12-296 IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
12/23/2019 Radiology 12-317 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
01/27/2015 Radiology 12-285 IEC 60601-2-1 Edition 3.1 2014-07 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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
12/23/2019 Radiology 12-329 IEC 60601-2-43 Edition 2.2 2019-10 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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