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This document is purchased as a PDF (Portable Document Format) and accessed via CSA OnDemand™, where you can view, navigate, and print it, or download it for offline use with Adobe Acrobat Viewer. This PDF contains Digital Rights Management protection and is intended for individual use. Please see Terms of Use for CSA’s copyright license and more information.
The scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.
This European Standard specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions. Jet and very high frequency ventilation and oscillation are not considered in this part of the European Standard.
This European standard does not apply to devices covered by the scope of the EN 794 series. Masks and application accessories are adressed in Part 2 of this Standard (in preparation).
This European Standard does not cover external body ventilators as defined in EN ISO 4135.
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