Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment: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.This 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 ofspontaneously breathing patients.The requiremen