Regulations, Standards, And Codes; Device Classification; Requirements For Safety) - Dräger WBR82 Instructions For Use Manual

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04

Regulations, Standards, and Codes

The Air-Shields Resuscitaire Radiant Warmers comply with the following safety standards and
performance standards:
• EN 60601-1—1990, Medical Electrical Equipment, Part 1: General Requirements for Safety,
including Amendments 1 and 2
• EN 60601-1-2—2001, Collateral Standard: Electromagnetic Compatibility—Requirements and
Tests
• EN 60601-2-21—1994, Particular Requirements for the Safety of Radiant Warmers, including
Amendment 1
• UL 60601-1—2003, Medical Electrical Equipment, Part 1: General Requirements for Safety
• C22.2 No. 601.1.1—1994, Medical Electrical Equipment, Safety Requirements for Medical electrical
Systems
• Directive 2002/96/EC of the European Parliament and of the Council of 2003-01-27 on Waste
Electrical and Electronic Equipment (WEEE) Annex IV, prEN 50419
The Resuscitaire Birthing Room Warmer (WBR82) and the Resuscitaire Radiant Warmer (RW82) meet
the following regulations, standards, and codes:
• EN794-1:1997, Lung ventilators, Part 1: Particular requirements for critical care ventilators, including
Amendment 1: 2000
• EN10079-1:1996 or 1999, Medical suction equipment - Part 1: Electrically powered suction equipment
- Safety requirements (ISO 10079-1:1991, including technical corrigendum 1:1992 and technical
corrigendum 2:1993)
• EN12342: 1998, Breathing tubes intended for use with anaesthetic apparatus and ventilators
NOTE:
These regulations, standards, and codes do not apply to the Resuscitaire Wall Mounted Radiant Warmer
(WMRW82) only because it is not equipped with resuscitation or suction equipment.
Device Classification (EN60601 Medical Electrical Equipment Part I: General

Requirements for Safety)

The Air-Shields Resuscitaire Radiant Warmers meet the requirements for the following classifications:
• Class I
• Type BF
• IPX0—ordinary equipment
• Not AP
• Continuous operation
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