Emc Standards Classification; Dicom Standard - FujiFilm VisualSonics Vevo MD User Manual

The system complies with the electromagnetic compatibility (EMC) limits as per the
following standards:
IEC 60601-1-2:2007 / EN 60601-1-2:2007/AC:2010 / CSA C22.2 No. 60601-1-
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2:08, Medical electrical equipment - part 1-2: general requirements for basic
safety and essential performance - collateral standard: electromagnetic
disturbances - requirements and tests
EN 55011:2009/A1:2010, CISPR 11:2003/A1:2004, Class A Group 1 -
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Industrial, scientific and medical equipment - radio-frequency disturbance
characteristics - limits and methods of measurement
FCC Part 15 Subpart B:2012
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EMC standards classification

Standard
IEC 60601-1-2:2007
CISPR 11:2004
The Classification for the ultrasound system, accessories, and peripherals when
configured together is: Group 1, Class A.

DICOM standard

NEMA PS 3.15: 2011, Digital Imaging and Communications in Medicine (DICOM)-
Part 15: Security and System Profiles.
406 Appendices
EMC standards classification
Medical Electrical Equipment. General
Requirements for Basic Safety and Essential
Performance-Collateral Standard.
Electromagnetic Compatibility. Requirements
and Tests.
Industrial, Scientific, and Medical (ISM) Radio-
Frequency Equipment Electromagnetic
Disturbance Characteristics-Limits and Methods
of Measurement.
Description