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SSH 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 (ISO 10651-2:2004)

Nov 9, 2009

General information

60.60     Nov 9, 2009

DPS

DPS/KT 215

European Norm

11.040.10  

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Scope

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.

Related directives

Directives related to this standards.

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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NOW

PUBLISHED
SSH EN ISO 10651-2:2009
60.60 Standard published
Nov 9, 2009

REVISED BY

WITHDRAWN
SSH EN ISO 10651-2:2004

Related project

Adopted from EN ISO 10651-2:2009