Samsung SONOACE R7 Instrukcja Użytkownika Pobierz pdf (Strona 9)

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101

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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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