Standards Compliance; Design Standards - Siemens SONOLINE G50 Instructions For Use Manual

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
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