– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and
Essential Performance [ANSI /AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND
A2:2010(R)2012]
– Biological Evaluation of Medical Devices – Part 1: evaluation and testing [ISO 10993-1:
2009]
– Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157:2007]
Statements
Nemko-CCL mark with the indicators “C” and “US” means that
the product is certified for both the U.S. and Canadian markets,
to the applicable U.S. and Canadian standards.
This mark certifies that the product conforms to applicable EEC
standards and has been certified by the European certification
agency.
This mark certifies that the product conforms to applicable EEC
standards.
The GMP symbol indicates the Good Manufacturing Practice in
accordance with the Korean quality management regulations.
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