Standards Compliance - Dräger Resuscitaire WBR82 Instructions For Use Manual

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04

Standards Compliance

EN 60601-1: 1990/A1:1993
IEC 60601-1: 1988/A1:1991/A2:1995
EN 60601-1-2—2001/A1:2006
IEC 60601-1-2:2001/A1:2004
EN 60601-2-21: 1994/A1—1996
IEC 60601-2-21:1994/A1—1996
CAN/CSA C22.2 No. 601.1—M90
CAN/CSA C22.2 No. 601.1.21-98
EN 50419
EN794-1:1997
EN10079-3:1999
EN12342: 1998
ISO14971: 2007
ISO 10651-5: 2006
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Medical Electrical Equipment, Part 1: General
Requirements for Safety
Medical Electrical Equipment, Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility—Requirements
and Tests
Medical Electrical Equipment, Part 2: Particular
Requirements for the Safety of Radiant Warmers
Medical Electrical Equipment, Safety Require-
ments for Medical Electrical Systems
Directive 2002/96/EC of the European Parliament
and of the Council of 2003-01-27 on Waste Elec-
trical and Electronic Equipment (WEEE) Annex
IV
Lung ventilators, Part 1: Particular requirements
for critical care ventilators, including Amendment
1: 2000
NOTE:
Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.
Medical suction equipment - Part 3: Suction equip-
ment powered from a vacuum or pressure source
NOTE:
Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.
Breathing tubes intended for use with anesthetic
apparatus and ventilators
NOTE:
Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.
Medical devices, Application of risk management
to medical devices
Lung ventilators for medical use: Particular
requirements for basic safety and essential perfor-
mance — Part 5:Gas-powered emergency resusci-
tators