Compliance; International Standards; Iec 601-1 Classification - Respironics BiPAP Focus Operator's Manual

Noninvasive ventilator system

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Chapter 9: Compliance

• IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC

60601-1:1988 + A1:1991 + A2:1995

Medical Electrical Equipment Part 1: General Requirements for

Safety, plus 1st and 2nd Amendments to the standard

• EN 60601-1-2 + A1:2000, Second Edition

Medical Electrical Equipment - Electromagnetic Compatibility

Requirements and Tests

• EN ISO 10651-6:2004

Lung Ventilators for Medical Use - Particular Requirements for

Basic Safety and Essential Performance

IEC 60601-1 Classification

Class I, Type BF, internally powered, drip-proof equipment, continuous

operation.

BiPAP® Focus™ Noninvasive Ventilator System

1027404 Rev K

Compliance

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