Samsung PT60A User Manual download pdf (Page 9)

X 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]

X Medical Devices – Application of Risk Management to Medical Devices [ISO 14971: 2007]

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

X Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA C22.2 No. 601.1-

M90: 1990, with R2003, with R2005]

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

process [ISO 10993-1: 2009]

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

Equipment [IEC 61157: 2007]



Declarations

This mark means that the product is certified for both the U.S. and Canadian

markets, to the applicable U.S. and Canadian safety standards.

This is the manufacturer’s declaration of product compliance with applicable EEC

directive(s) and the European notified body.

This is the manufacturer’s declaration of product compliance with applicable EEC

directive(s).

This is the GMP symbol that shows that the product complies with the Korean

Good Manufacturing Practice quality regulation system.

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Samsung PT60A User Manual Page 9