PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04
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Standards Compliance
EN 60601-1: 1990/A1:1993
IEC 60601-1: 1988/A1:1991/A2:1995
Medical Electrical Equipment, Part 1: General
Requirements for Safety
EN 60601-1-2—2001/A1:2006
IEC 60601-1-2:2001/A1:2004
Medical Electrical Equipment, Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility—Requirements
and Tests
EN 60601-2-21: 1994/A1—1996
IEC 60601-2-21:1994/A1—1996
Medical Electrical Equipment, Part 2: Particular
Requirements for the Safety of Radiant Warmers
CAN/CSA C22.2 No. 601.1—M90
CAN/CSA C22.2 No. 601.1.21-98
Medical Electrical Equipment, Safety Require-
ments for Medical Electrical Systems
EN 50419 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
EN794-1:1997 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.
EN10079-3:1999 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.
EN12342: 1998 Breathing tubes intended for use with anesthetic
apparatus and ventilators
N
TE:
Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.
ISO14971: 2007 Medical devices, Application of risk management
to medical devices
ISO 10651-5: 2006 Lung ventilators for medical use: Particular
requirements for basic safety and essential perfor-
mance — Part 5:Gas-powered emergency resusci-
tators
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