Siemens SONOLINE G50 - Standards Compliance; Design Standards

6 T e chnical Description
[ 1 ] I N S T R U C T I O N S F O R U S E 6 - 2 7
Standards Compliance
The SONOLINE G60 S ultrasound imaging system and the SONOLINE G50
ultrasound imaging system are 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 9000:2000
 ISO 13485:2003
 EN 46001:1996
Design Standards
 UL 60601
 CSA C22.2 No. 601.1
 EN 60601-1 and IEC 60601-1
 EN 60601-1-1 and IEC 60601-1-1
 EN 60601-1-2 and IEC 60601-1-2 (Class B)
 EN 60601-2-25 and IEC 60601-2-25
 EN 60601-2-37 and IEC 60601-2-37
Acoustic Output Standards
 IEC 61157 (Declaration of Acoustic Power)
 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for
Diagnostic Ultrasound
 AIUM/NEMA UD-3, 1998 Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment
CE Declaration
The 115V and 230V versions of this product are provided with a CE marking
in accordance with the regulations stated in Council Directive 93/42/EEC of
June 14, 1993 concerning Medical Devices. Siemens Medical Solutions
USA, Inc., is certified by notified body 0123 to Annex II.3 – Full Quality
System.
Authorized EC Representative:
Siemens Aktiengesellschaft
Medical Solutions
Henkestraße 127
D-91052 Erlangen
Germany