ISO 10651-2:2004
Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients
Reference number
ISO 10651-2:2004
Версия 2
2004-07
В время отменен
ISO 10651-2:2004
35973
Отозвано (Версия 2, 2004)

Тезис

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.

Общая информация

  •  : Отозвано
     : 2004-07
    : Отмена международного стандарта [95.99]
  •  : 2
  • ISO/TC 121/SC 3
    11.040.10 
  • RSS обновления

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ