Samsung SONOACE R5 Manual do Utilizador Página 9

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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]
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Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157: 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).
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