− 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
■
Declarations
CSA 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 is the manufacturer’s declaration of product
compliance with applicable EEC directive (s) and the
European notified body.
This is the manufacturer’s declaration of product
compliance with applicable EEC directive (s).
This is the GMP symbol for Korean Good
Manufacturing Practice quality system regulation.
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