Standard Swedish standard · SS-EN 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 (ISO 10651-2:2004)

Status: Withdrawn

· Replaced by: SS-EN ISO 10651-2:2009
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Standard Swedish standard · SS-EN 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 (ISO 10651-2:2004)
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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 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.

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


Buy this standard

Standard Swedish standard · SS-EN 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 (ISO 10651-2:2004)
Subscribe on standards - Read more Dölj
Price: 1 197 SEK
standard ikon pdf

PDF

Price: 1 197 SEK
standard ikon

Paper

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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-37092

Edition: 1

Approved: 8/20/2004

No of pages: 39

Replaces: SS-EN 794-2

Replaced by: SS-EN ISO 10651-2:2009