User guide

118
EMC standards classification
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.
IEC 60601-1-2:2001, Medical Electrical Equipment—Part 1-2: General Requirements for
Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests.
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).
AAMI/ANSI/ISO 10993-5, Biological evaluation of medical devices—Part 5: Tests for In Vitro
cytotoxicity (2009).
AAMI/ANSI/ISO 10993-10, Biological evaluation of medical devices—Part 10: Tests for irritation and
delayed-type hypersensitivity (2002).
AAMI/ANSI/ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic
toxicity (2006).
AAMI/ANSI/ISO 10993-12, Biological evaluation of medical devices—Part 12: Sample preparation
and reference materials (2007).
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 standard
Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191.
45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.