User's Manual

DRT-MAN-093
18/74
1.1 Medical Equipment Safety Standards
1.1.1 Medical Equipment Classification
Type of protection
against electrical shock
Class I ME Equipment
Degree of protection
against electrical shock
Type B Applied Parts
(Applied Part: Detector panel)
Degree of protection
against ingress of water
IP54
Mode of operation
Continuous Operation
Flammable anesthetics
Not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
1.1.2 Product Safety Standards
USA and Canada
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2 Ed.4: 2014
Medical electrical equipment-Part 1-2:Collateral
standard: Electromagnetic compatibility-Requirements and
tests
European Union
IEC 60601-1:2005 + C1:2006 + C2:2007
+ A1:2012
Medical electrical equipment – Part1 : General requirements
for Safety
EN 60601-1-2:2015
Medical electrical equipment–Part 1-2 : Collateral standard:
Electromagnetic compatibility-Requirements and tests
IEC 60601-1-6 : 2010 + A1:2013
Medical electrical equipment –Part 1-6: General requirements
for basic safety and essential performance – Collateral
standard: Usability
IEC 62304:2006 + A1:2015
Medical device software–Software life cycle processes