User's Manual

Wireless Digital Flat Panel Detector Mars1717X
78 User Manual of Mars1717X
Requirements and tests
IEC 60601-2-54:2009+A1:2015
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential
performance of X ray equipment for radiography and
radioscopy
EN 60601-2-54:2010+A1:2015
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential
performance of X ray equipment for radiography and
radioscopy
CAN/CSA-C22.2 No. 60601-2-
54:11+GI1(R2016)+A1;
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential
performance of X ray equipment for radiography and
radioscopy
KS C IEC 60601-2-54:2012
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential
performance of X ray equipment 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: Usibility
EN 60601-1-6:2010+ A1:2015;
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance-Collateral standard: Usibility
CAN/CSA-C22.2 No. 60601-1-6:11+A1;
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance-Collateral standard: Usibility
KS C IEC 60601-1-6:2011;
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance-Collateral standard: Usibility
EN ISO 14971: 2019
Medical device Application of risk management to
medical devices
EN ISO 24971: 2010
Medical devices Guidance on the application of ISO
14971
ISO 15223-1:2016
Medical devices Symbols to be used with medical
device labels, labeling and information to be
supplied Part 1: General requirements
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 1041:2008+A1
Information supplied by the manufacturer of medical
devices
ISO 10993-1:2018
Biological evaluation of medical devices Part 1:
Evaluation and testing within a risk management
process
MDD (93/42/EEC) Medical Device Directive
EN ISO 13485:2016
Medical devices -- Quality management systems --
Requirements for regulatory purposes