Colin BP-S510, Operation Manual

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128
Item Compliant with
Invasive blood
pressure IEC60601-2-34:2000
Particular requirements for the safety, including essential performance, of
invasive blood pressure monitoring equipment
Capnography EN864:1996 Capnometers for use with humans-Particular requirements
ISO9918:1993 Capnometers for use with humans-Requirements
ISO21647:2004
Particular requirements for the basic safety and essential performance of
respiratory gas monitors
Electromagnetic
compatibility IEC60601-1, sub clause 36, IEC/
IEC60601-1-2:2001+A1:2004
Electromagnetic compatibility-requirements & test
IEC61000-3-2:2005 Harmonic Emission Ed 3.0
IEC61000-3-3:2005 Voltage Fluctuations/Flicker Emission Ed 1.2
IEC61000-4-2:2001 Electrostatic Discharge Ed 1.2
IEC61000-4-3:2002 Radiated RF electromagnetic field Ed 2.1
IEC61000-4-4:2004 Electrical fast transient/burst Ed 2.0
IEC61000-4-5:2005 Surge current Ed 2.0
IEC61000-4-6:2004 Conducted disturbances, induced by RF field Ed 2.1
IEC61000-4-8:2001 Power frequency (50/60Hz) magnetic field Ed 1.1
IEC61000-4-11:2004 Voltage dips, short interruption and voltage variation on
power supply input lines Ed 2.0
CISPR 11:1997 (EN55011:1998) Limits and methods of measurement of radio
disturbance characteristics of industrial scientific and medical (ISM) radio-
frequency equipment RF Emissions Group 1, Class B
Package ISTA (Procedure 1A, 1994 Rev.)
Pre-Shipment Test Procedures (Package)
Reliability IEC60068-2-27:1987 Environmental testing – Shock
IEC60068-2-6:1995 Environmental testing –Vibration
IEC60068-2-64:1993 Environmental testing: vibration, broad-band random
(digital control) and guidance
Labeling
EN1041:1998
Information supplied by the manufacturer with medical devices
Marking
IEC /TR60878:2003
Graphical symbols for electrical equipment in medical practice
EN980:2003 Graphical symbols for use in the labeling of medical devices
ISO7000:2004 Graphical symbols for use on equipment-index and synopsis
EN60417-1:1999
Graphical symbols for use on equipment-overview and application
EN60417-2:1999 Graphical symbols for use on equipment-symbol originals
EN50419:2005 Marking of electrical and electronic equipment in accordance
with article II (2) of directive 2002/96/EC (WEEE)