Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 2: Home care ventilators for ventilator-dependent patients
This standard has been revised by: ISO 80601-2-72:2015
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.
ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.
ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.
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.
Document published on: 2004-07 Edition: 2 (Monolingual) ICS: 11.040.10 Status: Withdrawn Stage: 95.99 (2015-09-01) TC/SC: ISO/TC 121/SC 3 Number of Pages:
Revised by: ISO 80601-2-72:2015
Revises: ISO 10651-2:1996
No corrigenda or amendments available