Samsung SONOACE R3 Instrukcja Użytkownika Pobierz pdf (Strona 10)

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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]

 Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003]

 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential

Performance [CAN/CSA-C22.2 No. 60601-1:14]

 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential

Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012]

 Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management

process [ISO 10993-1:2009]

 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

certied 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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