User's Manual

Regulatory Information
iRay Technology Co. Ltd. 76
KS C IEC 60601-1
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
JIS T0601-1:2012
Medical electrical equipment– Part 1: General
requirements for basic safety and essential
performance
SS-EN 60601-1:2006+A11:2011+A1:2013+AC1:2014+A12:2014
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:
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
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
SS-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
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
KS C IEC 60601-1-6:2011
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