Samsung SONOACE R3 Bedienungsanleitung PDF herunterladen (Seite 10)

X

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

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

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 Basic Safety and Essential Performance

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

X 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]

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:

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 the manufacturer’s declaration of product compliance with

applicable EEC directive(s) and the European notied body.

This is the manufacturer’s declaration of product compliance with

applicable EEC directive(s).

This is the GMP symbol for Korean Good Manufacturing Practice quality

system regulation.

1 2 ... 5 6 7 8 9 10 11 12 13 14 15 ... 307 308

Keine Kommentare

Samsung SONOACE R3 Bedienungsanleitung Seite 10