Clarius Scanner HD3 Standards
revision 9 71
The Clarius Ultrasound Scanner meets the minimum requirements for compliance with the
European Union’s Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU and its
amendments.
Electrical Safety
Labeling
ISO 60417:2014 - Graphical symbols for use on equipment. See the Symbols Glossary in this
User Manual.
Quality
Performance
Reference No. Year Title
IEC 61157 2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic
equipment
IEC 62133 2012 Secondary cells and batteries containing alkaline or other non-acid electrolyte - Safety
requirements for portable sealed secondary cells, and for batteries made from them, for
use in portable applications
ST/SG/AC.10/11/Rev.5 2009
UN38.3
Transport of Dangerous Goods.
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)
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