Acteon X-MIND prime - Reference Standards and Regulatory Compliance

User Manual – Technical characteristics
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C
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6.6 Reference standard
Medical electrical equipment for extra-oral dental radiography X-MIND prime complies
with:
IEC 60601 1: 2005 (3rd ed.)
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
IEC 60601 1: 2005 (3rd ed.) + Am1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-6:2010 (3rd Ed.)
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral
Standard: Usability including IEC 62366: Application of usability engineering to medical
devices.
IEC 60601-1-6:2010 (3rd Ed.) + Am1:2013
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral
Standard: Usability including IEC 62366: Application of usability engineering to medical
devices.
IEC 60601-1-2:2007 (3rd Ed.)
Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-2:2014 (4th Ed.)
Electromagnetic disturbances - Requirements and tests.
IEC 60601-1-3:2008 (2nd Ed.)
Medical electrical equipment - Part 1-3: General Requirements for Radiation Protection
in Diagnostic X-Ray Equipment.
IEC 60601-1-3:2008 (2nd Ed.) + Am1:2013 (ed. 2.1)
Medical electrical equipment - Part 1-3: General Requirements for Radiation Protection
in Diagnostic X-Ray Equipment.
IEC 60601-2-63:2012 (1st ed.)
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and
essential performance of extra-oral dental X-ray equipment.
IEC 60601-2-63:2012 (1st ed.) + Am1:2017 (ed. 1.1)
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and
essential performance of extra-oral dental X-ray equipment.
IEC 62366:2007 (1st Ed.)
Medical devices – Application of usability engineering to medical devices.
IEC 62366:2007 (1st Ed.) + Am1:2013
Medical devices – Application of usability engineering to medical devices.
IEC 62304:2006 (1st Ed.) + Ac:2008
Medical devices software – Software life-cycle processes.
IEC 62304:2006 (1st Ed.) + Am1:2015 (ed. 1.1)
Medical devices software – Software life-cycle processes.
IEC 60825-1:1993 (1nd ed.)
Safety of laser product – Part 1: equipment classification and requirements.
IEC 60825-1:2007 (2nd ed.)
Safety of laser product – Part 1: equipment classification and requirements.