SS-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 (ISO 10651-2:2004)

SS-EN-ISO-10651-2 - 2009 EDITION - SUPERSEDED
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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 of spontaneously breathing patients. 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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Designation Name

SS-EN ISO 10651-2:2009

Revision Level

2009 EDITION

Status

Superseded

Publication Date

April 20, 2009

Language(s)

English

Page Count

52

International Equivalent

EN ISO 10651-2:2009(IDT); ISO 10651-2:2004(IDT)