Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
|Publication Date:||1 January 2006|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
IEC 60601-1:1988, Clause 1 applies, except as follows.
This part of ISO 10651 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.
his part of ISO 10651 is not applicable to cuirass and "iron-lung" ventilators.
This part of ISO 10651 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.
The requirements of this part of ISO 10651 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.