NEN-EN-ISO 10651-2
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
| Organization: | NEN |
| Publication Date: | 1 May 2009 |
| Status: | inactive |
| Page Count: | 52 |
| ICS Code (Anaesthetic, respiratory and reanimation equipment): | 11.040.10 |
scope:
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. 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.
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