Acoustic Standards; Biocompatibility Standards; Airborne Equipment Standards; Dicom Standard - FujiFilm SonoSite M-Turbo User Manual

IEC 60601‐1:2012, Medical electrical equipment ‐
Part 1: General requirements for basic safety and
essential performance [Edition 3.1].
IEC 60601‐2‐37:2001, International
Electrotechnical Commission, Particular
Requirements for the Safety of Ultrasonic
Medical Diagnostic and Monitoring Equipment.
IEC 60601‐2‐37:2007, Medical electrical
equipment ‐ Part 2‐37: Particular requirements
for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring
equipment.
IEC 61157, International Electrotechnical
Commission, Standard Means for the Reporting
of the Acoustic Output of Medical Diagnostic
Ultrasonic Equipment.EMC standards
classification
IEC 60601‐1‐2:2007, Medical electrical equipment
‐ Part 1‐2: General requirements for basic safety
and essential performance ‐ Collateral standard:
Electromagnetic compatibility ‐ Requirements
and tests.
CISPR 11, International Electrotechnical
Commission, International Special Committee on
Radio Interference. Industrial, Scientific, and
Medical (ISM) Equipment ‐ Radio‐Frequency
Disturbance Characteristics‐Limits and Methods
of Measurement. Classification for the
ultrasound system, docking system, accessories,
and peripherals when configured together:
Group 1, Class A.

Acoustic standards

NEMA UD 2‐2004, Acoustic Output
Measurement Standard for Diagnostic
Ultrasound Equipment.
NEMA UD 3‐2004, Standard for Real‐Time
Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in
Medicine.

Biocompatibility standards

AAMI/ANSI/ISO 10993‐1, Biological evaluation
of medical devices ‐ Part 1: Evaluation and testing
(2009).

Airborne equipment standards

RTCA/DO‐160E, Radio Technical Commission
for Aeronautics, Environmental Conditions and
Test Procedures for Airborne Equipment,
Section 21.0 Emission of Radio Frequency
Energy, Category B.118.

DICOM standard

NEMA PS 3.15, Digital Imaging and
Communications in Medicine (DICOM)‐Part 15:
Security and System Management Profiles.
HIPAA standard45 CFR 160, General
Administrative Requirements.
45 CFR 164, Security and Privacy.
Chapter 8: Specifications 187