Project No.ISO 10651-2:2004
Title<p>ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. </p> <p>ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.</p> <p>ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.</p> <p>ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.</p> <p>The requirements of ISO 10651-2:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.</p>
Registration number (WIID)35973
Scope<p>ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. </p> <p>ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.</p> <p>ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.</p> <p>ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.</p> <p>The requirements of ISO 10651-2:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.</p>
StatusAtcelts
ICS group11.040.10