Appendix A Technical Description
A - 42 Instructions for Use
Standards Compliance
The ultrasound system is in compliance with the following standards, including all applicable
amendments at the time of product release.
Quality Standards
 FDA QSR 21 CFR Part 820
 ISO 13485
 ISO 9001
Design Standards
 UL 60601-1
 CSA C22.2 No. 601.1
 EN 62304 and IEC 62304
 EN 62366 and IEC 62366
 EN 60601-1 and IEC 60601-1
 EN 60601-1-2 and IEC 60601-1-2 (Class B)
Note: The system is a Class A device when the ACUSON AcuNav ultrasound catheter is in use.
Note: The system is a Class A device when the ACUSON S2000 Automated Breast Volume
Scanner is in use.
Note: The ultrasound system is a Class A device when the eSieFusion is in use.
 EN 60601-1-6 and IEC 60601-1-6
 EN 60601-2-18 and IEC 60601-2-18
 EN 60601-2-37 and IEC 60601-2-37
 ISO 14971
Acoustic Output Standards
 IEC 62359
 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
 AIUM/NEMA UD-3, Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment
Radio and Telecommunications Standards
 CFR 47 FCC Part 15.247
 CFR 47 FCC Part 15.107
 CFR 47 FCC Part 15.109
 ETSI EN 300 328
 ETSI EN 301 489-1
 ETSI EN 301 489-17
 ETSI EN 301 893
To Next Page
Loading...
Need help?
General