User's Manual Part 2

Rev.1.5 Page 101 of 121 D-16-207
VIVIX-S 1417N User Manual
U.S.A / Canada
Item
ANSI/AAMI ES60601-1(2005) +
AMD1(2012)
Medical electrical equipment – Part1: General requirements for
basic safety and essential performance
CAN/CSA-C22.2 No. 60601-1(2014)
Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance (adopted IEC 60601-1:2005,
including Amendment 1:2012, with Canadian deviations)
IEC 60601-1-2: 2007(ed.3)
Medical electrical equipment-Part 1-2: Collateral Standard :
Electromagnetic compatibility
IEC 62304:2006
Medical device software-software life cycle processes
ISO 14971:2012
Medical Device- Application of risk management to medical
devices
European Union
Item
MDD (Medical Device Directive)
93/42/EEC as amended by 2007/47/EC
EN ISO 13485:2012
Medical devices – Quality Management systems – Requirements for
regulatory purposes
EN 60601-1: 2006/A1:2013
Medical electrical equipment- Part1: General requirements for basic
safety and essential performance
EN 60601-1-2: 2007(ed.3)
Medical electrical equipment-Part 1-2: Collateral Standard :
Electromagnetic compatibility-Requirements and tests
EN 62304:2006
Medical device software-Software life cycle processes
ISO 14971: 2012
Medical device – Application of risk management to medical devices.