Applicable Standards - ResMed Elisee 150 Clinical Manual

9.4 Applicable standards

The ventilator meets the following standards:
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EN 60601-1:1990 / A1:1993 / A2:1995 / A13:1996: Medical Electrical Equipment. General
Requirements for Safety;
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EN 60601-1-2:2001: Electromagnetic Compatibility for Medical Electrical Equipment;
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IEC 60601-1-4:1996 / A1:1999: Programmable Electrical Medical Systems;
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NF EN ISO 14971: Medical Devices – Application of Risk Management to Medical Devices;
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EN ISO 10651-6:2004: Lung Ventilators for Medical Use – Special Requirements for Basic
Safety and Essential Performance – Part 6: Home Care Ventilatory Support Devices;
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European Directive WEEE 2002/96/EC - Proper disposal of waste electrical and electronic
equipment;
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Directive 93/42/EC, notified body TÜV Rheinland, CE0197;
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EN ISO 5356-1:2004: Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1:
Cones and Sockets.
For ventilators used with a double circuit:
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ISO 10651-2:2004: Lung ventilators for medical use - Part 2: Home care ventilators for
ventilator-dependent patients.
148/174
EN 55011, Class B,
EN 61000-4-2,
EN 61000-4-3,
EN 61000-4-4,
EN 61000-4-5,
EN 61000-4-6,
EN 61000-4-8,
EN 61000-4-11,
IEC 801-3,
EN 61000-3-2,
EN 61000-3-3,
NOT013189-6