User's Manual

Clarius Ultrasound Scanner - HD3 Scanners Standards
revision 1 67
Standards
Biocompatibility
ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process.
GB / T 16886.1-2011 - Biological Evaluation Of Medical Devices - Part 1: Evaluation and testing
within a risk management process
GB / T 16886.5-2016 - Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test
GB / T 16886.10-2016 - Biological evaluation of medical devices - Part 10: Stimulation and
delayed hypersensitivity test
Electrical Safety
Labeling
ISO 60417:2014 - Graphical symbols for use on equipment. See the Symbols Glossary in this
User Manual.
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.