Samsung SONOACE R5 Instrukcja Użytkownika Strona 9

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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]
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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 [UL60601-1:2003]
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Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2
No.601.1-M90:1990, with R2003, with R2005]
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Biological Evaluation of Medical Devices [ISO10993 : 2009]
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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).
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