V Series Operating Instructions 29 - 3
Product Specifications Specifications
29.1 Specifications
29.1.1 Standards Compliance
The V 12/V 21 Monitor is in compliance with following industry standards.
TABLE 29-1
ANSI/AAMI ES60601-1:2005/(R)2012 and
A1:2012,C1:2009/(R)2012 and A2:2010/
(R)2012
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular
requirements for the basic safety and essential performance
of multifunction patient monitoring equipment
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-8:2012 Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance -
collateral standard: general requirements, tests and
guidance for alarm systems in medical electrical equipment
and medical electrical systems
IEC 60601-1-6: 2013 Medical electrical equipment-Part 1-6: General
requirements for basic safety and essential performance--
collateral standard: usability
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular
requirements for the basic safety and essential performance
of electrocardiographs
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular
requirements for the basic safety and essential performance
of electrocardiographic monitoring equipment
AAMI/ANSI EC57:2012 Testing and reporting performance results of cardiac
rhythm and st-segment measurement algorithms
IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular
requirements for the basic safety, including essential
performance, of invasive blood pressure monitoring
equipment
IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical
validation of automated measurement type
ISO 80601-2-56:2009 Medical electrical equipment - Part 2-56: Particular
requirements for basic safety and essential performance of
clinical thermometers for body temperature measurement
ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment
IEC 60601-2-26:2002 Medical electrical equipment – Part 2-26: Particular
requirements for the basic safety of electroencephalographs
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