− Medical electrical equipment, part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment IEC 60601-2-37:2001, A1:2004, A2:2005
− Medical devices - Application of risk management to medical devices ISO
14971:2007
− Medical electrical equipment, part 1: General requirements for safety UL
60601-1:2003
− Medical electrical equipment - part 1: General requirements for safety
CAN/CSA C22.2 No. 601.1-M90:1990, R2003, R2005
− 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
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Statements
This is the CSA symbol used in Canada and the
United States.
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.
GMP symbol represents the good manufacturing
practice and quality standards in accordance with
the Korean Quality Standards.
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