
14
Mars1417VS Wireless Digital Flat Panel Detector
BS EN 60601-1:2006+A11:2011 Medical electrical equipment –Part 1: General requirements
for basic safety and essential performance
ANSI/AAMI ES60601-1:2005/
(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/
(R)2012
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
CAN/CSA-C22.2 No.60601-1:14 Medical electrical equipment –Part 1: General requirements
for basic safety and essential performance
IEC 60601-2-54:2009+A1:2015
Medical electrical equipment –Part 2-54: Requirements for
the basic safety and essential performance of X-ray equip-
ment for radiography and radioscopy
CAN/CSA-C22.2 NO. 60601-2-54:11
Medical electrical equipment –Part 2-54: Requirements for
the basic safety and essential performance of X-ray equip-
ment for radiography and radioscopy
IEC 60601-1-6:2010+A1:2013
Medical electrical equipment Part 1-6: General requirements
for basic safety and essential performance — Collateral
standard: Usability
CAN/CSA-C22.2 NO. 60601-1-6:11+A1:2015
Medical electrical equipment Part 1-6: General requirements
for basic safety and essential performance — Collateral
standard: Usability
EN 60601-1-6:2010+A1:2015
Medical electrical equipment Part 1-6: General requirements
for basic safety and essential performance — Collateral
standard: Usability
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General require-
ments for basic safety and essential performance– Collateral
standard: Electromagnetic disturbances– Requirements and
tests
IEC 62133-2:2017
Secondary cells and batteries containing alkaline or other
non-acid electrolytes-safety requirements for portable sealed
secondary lithium cells, and for batteries made from them,
for use in portable applications-part 2: lithium systems.
EN 62220-1-1:2015
Medical electrical equipment – Characteristics of digital
X-ray imaging devices–Part 1-1: Determination of the de-
tective quantum eciency
EN 62304:2006/AC:2008 Medical device software – Software life-cycle processes
EN 62366:2008 Medical devices – Application of usability engineering to
medical devices
ISO 15223-1:2016
Medical devices-symbols to be used with medical device la-
bels, labeling and information to be supplied–Part1: General
requirements
Radio Frequency (RF) Energy
• This device is designed and manufactured not to exceed the emission limits for exposure to radio
frequency (RF) energy set by the Federal Communications Commission of theUnited States.
• During SAR testing, this device was set to transmit at its highest certified power level in all tested
frequency bands, and placed in positions that simulate RF exposure in usage against the body with no
separation. Although the SAR is determined at the highest certified power level, the actual SAR level
of the device while operating can be well below the maximum value.