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
USA :
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
ANSI/AAMI/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
FDA 21 CFR 1020.30 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
IEC 60601-2-54:2022 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management
ANSI/HPS N13.30 2011 Performance Criteria for Radiobioassay
21CFR1020.31 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS: Radiographic equipment.
Europe:
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 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
EN IEC 60601-2-43:2023(MAIN) Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
EN 60601-2-43:2010/AC:2014 - Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures EN IEC 61223-3-5:2019(MAIN) Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
EN 60601-2-45:2011(MAIN) Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
EN 61676:2002(MAIN) Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
EN 60601-1-2:2015(MAIN) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
China:
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB 9706.263-2020 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
GB 9706.243-2021 - Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
GB 9706.208-2021 - 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
GB 9706.265-2021 - Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
GB 9706.244-2020 - Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
GB 9706.245-2020 - Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
GB 9706.228-2020 - Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
GB 9706.103-2020 - Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.254-2020 - Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Japan:
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
JIS T 15001-2-43:2017: Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
JIS T 15001-2-44:2017: Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Korea:
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS C IEC60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
KS C IEC60601-1-2: Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
KS C IEC60601-2-63: Medical electrical equipment ─ Part2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
KS C IEC60601-2-43: Medical electrical equipment ─ Part 2-43: Particular requirements for basic safety and essential performance of interventional X-ray devices
Taiwan:
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 15587 Medical diagnostic X-ray equipment – Radiation conditions for use in the determination of characteristics
CNS 15586 Medical electrical equipment – X-ray tube assemblies for medical diagnosis –Characteristics of focal spots
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.
Australia:
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS IEC 60601.2.65:2022 Medical electrical equipment, Part 2.65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
AS/NZS IEC 60601.1.3:2015 Medical electrical equipment - Part 1.3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
AS/NZS IEC 60601.2.8:2015 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
AS/NZS 61223.3.4:2022 Evaluation and routine testing in medical imaging departments, Part 3.4: Acceptance tests - Imaging performance of dental X-ray equipment
AS/NZS IEC 60601.2.44:2022 Medical electrical equipment, Part 2.44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
AS/NZS IEC 60601.2.28:2015 Medical electrical equipment - Part 2.28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
AS/NZS 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
AS/NZS 60601.2.63:2022 Medical electrical equipment, Part 2.63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
AS/NZS IEC 61223.3.5:2022 Evaluation and routine testing in medical imaging departments Part 3.5: Acceptance and constancy tests — Imaging performance of computed tomography X-ray equipment
South Africa:
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
SANS 60601-2-43:2022 (Ed. 1.02): Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
SANS 60601-2-45:2019 (Ed. 1.00): Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
SANS 60601-2-63:2019 (Ed. 1.01): Medical electrical equipment Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
SANS 60601-2-65:2019 (Ed. 1.01): Medical electrical equipment Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Saudi Arabia:
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO 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
GSO IEC 60601-2-44:2014 Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Computed Tomography
GSO IEC 61267:2014 Medical Diagnostic X-Ray Equipment - Radiation Conditions For Use In The Determination Of Characteristics
EAEU:
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST 25675-2022 High-voltage cable plug and socket connections for medical X-ray equipment. Types and basic sizes
GOST 22091.11-80 X-ray devices. The method of the measuring of the time operation readiness of the device
GOST 22091.1-84 X-ray devices. The methods of measuring of heater current and heater voltage
GOST 22091.8-84 X-ray devices. The method of measuring of spectral structure and relative spectrum contamination
GOST 22091.5-86 X-ray devices. The method of measuring of the X-ray tube current
GOST 22091.10-84 X-ray devices. The method of measuring AL(CU) equivalent of X-ray device envelope
GOST 22091.14-86 X-ray devices. The method of measuring the energy flow density (photon flux density) of X-radiation
GOST 22091.12-84 X-ray devices. The methods of measuring of currents and electrode voltage per pulse
GOST 22091.6-84 X-ray devices. Methods of measuring X-radiation exposure dose power and X-radiation exposure dose per pulse
