Standards Compliance; Quality Standards; Design Standards; Acoustic Output Standards - Siemens ACUSON Antares Instructions For Use Manual

Standards Compliance

The Antares 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 13485:2003
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 60601-2-37 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

This product is 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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