− 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 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
■ Statements
The “C” and “US” of the CSA mark certifies that the product
conforms to applicable Canadian and American standards and
has been certified by Canadian and American certification
agencies.
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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