Standards Compliance; Quality Standards; Design Standards - Siemens Acuson S1000 Instructions For Use Manual

A p p e n d i x A T e c h n i c a l D e s c r i p t i o n

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

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