Samsung MYSONO U6 Uživatelský manuál Strana 10

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X Medical Electrical Equipment, Part 2: Particular Requirements for Safety - 37 Ultrasonic Medical
Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with A1:2004, A2:2005]
X Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
X Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]
X Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2
No.601.1-M90:1990, with R2003, with R2005]
X Biological Evaluation of Medical Devices [ISO10993 : 2009]
X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC61157:2007]
Declarations
This is CSA symbol for Canada and United States of America
This is manufacturer’s declaration of product compliance with applicable EEC
directive(s) and the European notied body.
This is manufacturer’s declaration of product compliance with applicable EEC
directive(s).
This is GMP symbol for Good Manufacturing Practice of Korea quality system
regulation.
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