Biocompatibility Standards; Airborne Equipment Standards; Dicom Standard; Hipaa Standard - FujiFilm SonoSite Edge II User Manual

Biocompatibility standards

AAMI/ANSI/ISO 10993-1:2009, 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: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.
The system conforms to the DICOM standard as specified in the 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.
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.
Standards 173