X-RAY machine

Safety : IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-2-43:2022 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

EMC : IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

Performance : IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

Local Standard

Brasil:
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ABNT NBRIEC61674 DE 07/2016 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
ABNT NBRIEC60601-2-65 DE 03/2020 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
ABNT NBRIEC60601-2-63 DE 02/2020 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
ABNT NBRIEC60601-2-8 DE 03/2020 Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
ABNT NBRIEC60601-2-54 DE 03/2020 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Mexico:
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-229-SSA1-2002 Goods and services. Radiological health. General requirements for the installation and operation of diagnostic radiology, fluoroscopy and dental equipment.

Argentina:
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IRAM 60336 Electromedical devices. X-ray tube assembly for medical diagnosis. Characteristics of the focal points.
IRAM 4220-1-3 Electromedical devices. Part 1: General security requirements. 3. Collateral standard: General requirements for radioprotection in diagnostic X-ray devices.
IRAM 4220-2-7 Electromedical devices. Part 2-7: Particular safety requirements for high voltage generators of diagnostic X-ray generating equipment.