Standards Compliance; Quality Standards; Design Standards; Acoustic Output Standards - Siemens ACUSON X300 User And Reference Manual

Standards Compliance

(For ACUSON X300 PE 7.5: replaces the Standards Compliance, Technical Description,
Appendix A, Instructions for Use; the Acoustic Output Standards and CE Declaration are
unchanged.)
(For ACUSON X300 2.5: replaces the Standards Compliance, Technical Description,
Chapter 6, [1] Instructions for Use; the Acoustic Output Standards and CE Declaration are
unchanged.)
(For ACUSON X150 2.5: replaces the Standards Compliance, Technical Description,
Appendix A, Instructions for Use; the Acoustic Output Standards and CE Declaration are
unchanged.)

Quality Standards

 FDA QSR 21 CFR Part 820
 ISO 13485 (Canadian), CMDR regulation
 EN ISO 9001:2008

Design Standards

 UL 60601-1
CAN/CSA-C22.2 No. 601.1

 EN 60601-1 and IEC 60601-1 (2nd and 3rd Ed.)
 EN 60601-1-1 and IEC 60601-1-1
 EN 60601-1-2 and IEC 60601-1-2
 EN 60601-1-4 and IEC 60601-1-4
 EN 62304 and IEC 62304
 EN 60601-1-6 and IEC 60601-1-6
 EN 62366 and IEC 62366
 EN 60601-2-18 and IEC 60601-2-18
EN 60601-2-25 and IEC 60601-2-25

 EN 60601-2-37 and IEC 60601-2-37
 EN ISO 14971
 EN ISO 10993-1

Acoustic Output Standards

 IEC 61157 (Declaration of Acoustic Power)
 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
IEC 62359 (Test methods for the determination of thermal and mechanical indices, 2005)


Radio and Telecommunications Standards

(The Radio and Telecommunications Standards is an addition to the Standards Compliance
section.)
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
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