<p>For ISO 17510-1:2002, the scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.</p>
<p>ISO 17510-1:2002 specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions.</p>
<p>ISO 17510-1:2002 is not applicable to jet and very high frequency ventilation and oscillation.</p>
<p>ISO 17510-1:2002 is not applicable to devices covered by the scope of the EN 794 series.</p>
<p>ISO 17510-1:2002 is not applicable to external body ventilators as defined in ISO 4135.</p>
<p>NOTE Masks and application accessories are addressed in ISO 17510-2.</p>
Registration number (WIID)
30713
Scope
<p>For ISO 17510-1:2002, the scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.</p>
<p>ISO 17510-1:2002 specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions.</p>
<p>ISO 17510-1:2002 is not applicable to jet and very high frequency ventilation and oscillation.</p>
<p>ISO 17510-1:2002 is not applicable to devices covered by the scope of the EN 794 series.</p>
<p>ISO 17510-1:2002 is not applicable to external body ventilators as defined in ISO 4135.</p>
<p>NOTE Masks and application accessories are addressed in ISO 17510-2.</p>
