Trio™ Operating Instructions 0070-10-0666-01 6 - 3
Appendix Specifications
6.1.3 Performance / Accuracy
EN 865:1997 Pulse Oximeters - Particular Requirements
EN 1060-1:1995 Specification for Non-invasive
Sphygmomanometers
EN 1060-3:1997 Non-invasive Sphygmomanometers,
Supplementary Requirements for
Electromechanical Blood Pressure Measuring
Systems
ANSI/AAMI EC13:2002 Cardiac Monitors, Heart rate Meters, and
Alarms
ISO 3744:1994 Acoustics - Determination of Sound Power
Levels of Noise Sources Using Sound
Pressure
ANSI/AAMI/ISO 10993-1:1997 Biological evaluation of medical devices -
Part 1: Evaluation and Testing
ANSI/AAMI SP-10:1992 Electronic or Automated
Sphygmomanometers
EN475:1995 Medical Devices, Electrically-generated
Alarm Signals
EN 1041:1998 Information Supplied by the Manufacturer
with Medical Systems
EN 980:1996 + A1:1999 + A2:2001 Graphical Symbols for Use in Labeling of
Medical Devices
IEC 878:1998 Graphical Symbols for Electrical Equipment
in Medical Practice
ISO 1000:1992 + A1:1998 SI units and recommendations for the use of
their multiples and of certain other units
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