User's Manual

Table Of Contents
Clarius Ultrasound Scanner - HD3 Scanners Standards
revision 1 68
Quality
Performance
Reference No. Year Title
AIUM/NEMA UD 2-2004 2009 NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output Measurement
Standard For Diagnostic Ultrasound Equipment, Revision 3. (Radiology)
AIUM/NEMA UD 3-2004 2009 NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time Display
of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment
ANSI/AAMI ES60601-1 2005/(R)2012
A1:2012
C1:2009(R)2012
A2:2010(R)2012
Medical electrical equipment-Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005, MOD)
ANSI/AAMI/IEC 62304 2006
A1:2015
Medical device software – Software life cycle processes.
CAN/CSA-C22.2
No. 60601-1-6:11
2011 Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability (Adopted IEC 60601-1-
6:2010, third edition, 2010-01)
CAN/CSA-C22.2
No. 60601-1:14
2014 Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12,
including amendment 1:2012, with Canadian deviations)
IEC 60601-1 2012 Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic Capability -
Requirements and tests
IEC 60601-1-6 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard: Usability
IEC 60601-1-12 2014 Medical electrical equipment - Part 1-12: Requirements for Medical Electrical
Equipment and Medical Electrical Systems Intended For Use in the Emergency
Medical Services Environment
IEC 60601-2-37+ AMD1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment