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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
06/07/2018 Radiology 12-311 IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
06/07/2018 Radiology 12-310 IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
12/23/2019 Radiology 12-309 IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
06/27/2016 Radiology 12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016 Radiology 12-301 IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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