Owandy Radiology i-max touch 3D, User Manual

Page: 46 / 119

User Manual
– Technical characteristics
NIMXEN020I
Owandy Radiology SAS
36
6.5 Reference standard
Medical electrical equipment for extra-oral dental radiography I-MAX 3D 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 (1st 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.