Acteon X-MIND prime 3D ceph - Reference Standard

Service Manual - Technical characteristics
SERVICE MANUAL • X-MIND prime 3D • (19) • 11/2019 • NXMPEN080A
54
5.7 Reference standard
Medical electrical equipment for extra-oral dental radiography X-MIND prime 3D
complies with:
IEC 60601 1: 2005 (3
rd
ed.)
Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
IEC 60601 1: 2005 (3
rd
ed.) + Am1:2012
Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-6:2010 (3
rd
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 (3
rd
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 (3
rd
Ed.)
Electromagnetic compatibility – Requirements and tests.
IEC 60601-1-2:2014 (4
th
Ed.)
Electromagnetic disturbances – Requirements and tests.
IEC 60601-1-3:2008 (2
nd
Ed.)
Medical electrical equipment – Part 1-3: General Requirements for Radiation
Protection in Diagnostic X-Ray Equipment.
IEC 60601-1-3:2008 (2
nd
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 (1
st
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 (1
st
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 (1
st
Ed.)
Medical devices – Application of usability engineering to medical devices.
IEC 62366:2007 (1
st
Ed.) + Am1:2013
Medical devices – Application of usability engineering to medical devices.
IEC 62304:2006 (1
st
Ed.) + Ac:2008
Medical devices software – Software life-cycle processes.
IEC 62304:2006 (1
st
Ed.) + Am1:2015 (ed. 1.1)
Medical devices software – Software life-cycle processes.