Samsung SONOACE R3 Instrukcja Użytkownika Pobierz pdf (Strona 9)

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

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

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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]

Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2

No.601.1-M90:1990, with R2003, with R2005]

Biological Evaluation of Medical Devices [ISO10993 : 2009]

Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic

Equipment [IEC61157:2007]

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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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Samsung SONOACE R3 Instrukcja Użytkownika Strona 9