Mediana P10 Manual de Serviço descarregar pdf (Página 97)

Item Compliant with

Oxygen saturation ISO9919:2005 Basic safety & essential performance of pulse oximeter for

medical use

Temperature

monitoring

EN12470-4:2000

Performance of electrical thermometers for continuous Measurement

Capnography ISO21647:2004

Particular requirements for the basic safety and essential performance of

respiratory gas monitors

Electromagnetic

compatibility

IEC60601-1, sub clause 36, and

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

IEC61000-4-3:2006 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

IEC61000-4-6:2006 Conducted disturbances, induced by RF field Ed 2.2

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, 2001) Pre-Shipment test procedures (Package)

ASTM D4169:2005 Standard practice for performance testing of shipping

containers and system

IEC60068-1:1988 Environmental testing, Part1: General guidelines

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)

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