
■X
Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical
Diagnostic and Monitoring Equipment [IEC 60601-2-37: 2001 with A1: 2004, A2: 2005]
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Medical Devices – Application of Risk Management to Medical Devices [ISO 14971: 2007]
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Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1: 2003]
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Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA C22.2 No. 601.1-
M90: 1990, with R2003, with R2005]
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Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management
process [ISO 10993-1: 2009]
■X
Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157: 2007]
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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 notied body.
This is manufacturer’s declaration of product compliance with applicable EEC
directive(s).
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