Samsung SONOACE R3 Manuel d'utilisateur télécharger pdf (Page 10)

100

101

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Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:

Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]



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]



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]



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 , 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]

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Declarations:

CSA mark with the indicators “C” and “US” means that the product is

certified for both the U.S. and Canadian markets, to the applicable U.S.

and Canadian standards.

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 the GMP symbol for Korean Good Manufacturing Practice quality

system regulation.

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Samsung SONOACE R3 Manuel d'utilisateur Page 10

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