20 Chapter 3: System Overview
Electromechanical Safety Standards
EN 60601-1:1997, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety.
EN 60601-1-1:2001, European Norm, Medical Electrical Equipment–Part 1. General Requirements for
Safety–Section 1-1. Collateral Standard. Safety Requirements for Medical Electrical Systems.
EN 60601-2-37:2001, European Norm, Particular requirements for the safety of ultrasonic medical diagnostic and
monitoring equipment.
CAN/CSA C22.2, No. 601.1-M90:1990, Canadian Standards Association, Medical Electrical Equipment–Part 1.
General Requirements for Safety.
CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the Declaration of the Acoustic
Output of Medical Diagnostic Ultrasonic Equipment.
UL 60601-1:2003, Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for
Safety.
EMC Standards Classification
EN 60601-1-2:2001, European Norm, Medical Electrical Equipment. General Requirements for Safety-Collateral
Standard. Electromagnetic Compatibility. Requirements and Tests.
CISPR11:2004, International Electrotechnical Commission, International Special Committee on Radio Interference.
Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance
Characteristics-Limits and Methods of Measurement.
The Classification for the SonoSite system, SiteStand, accessories, and peripherals when configured together is:
Group 1, Class A.
Airborne Equipment Standards
RTCA/DO160D:1997, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures
for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B.
DICOM Standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.
HIPAA Standard
The Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191 (1996).
45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.
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