Emc Standards Classification; Dicom Standard; Hipaa Standard - FujiFilm SonoSite X-Porte User Manual

Table 9-6: Electromechanical safety standards (continued)
Standard
IEC 60601-1-6:2013
CSA C22.2
60601-2-37:08
CSA C22.2
60601-1-6:11+A1

EMC standards classification

Table 9-7: EMC standards classification
Standard
IEC 60601-1-2:2007
CISPR 11:2009
The Classification for the ultrasound system, docking system, accessories, and peripherals when configured
together is: Group 1, Class A.

DICOM standard

NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.
The system conforms to the DICOM standard as specified in the SonoSite X-Porte DICOM Conformance
Statement, available at www.sonosite.com. This statement provides information about the purpose,
characteristics, configuration, and specifications of the network connections supported by the system.

HIPAA standard

The system includes security settings that help you to meet the applicable security requirements listed in
the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic
protected health information collected, stored, reviewed, and transmitted on the system.
9-26
Description
Medical Electrical Equipment part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability (Edition 3.1b)
Medical Electrical Equipment – Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment (Adopted IEC 60601-2-37:2007, Edition 2.0)
Medical Electrical Equipment part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability (Adopted IEC
60601-1-6:2013, Edition 3.1)
Description
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.
Safety