DS/EN ISO 10651-2:2009
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients

Standard No.

DS/EN ISO 10651-2:2009

Release Date

2009

Published By

Danish Standards Foundation

Latest

DS/EN ISO 10651-2:2009

Replace

DS/EN ISO 10651-2:2004

Scope

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

DS/EN ISO 10651-2:2009 history

• 2009 DS/EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
• 0000 DS/EN ISO 10651-2:2004