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CSA Z10651-2

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients

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Organization: CSA
Publication Date: 1 January 2006
Status: active
Page Count: 50
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
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.

his 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.

Document History

February 1, 2006
Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator dependent patients
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...
February 1, 2006
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
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...
CSA Z10651-2
January 1, 2006
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients
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...
March 1, 1999
Lung Ventilators for Medical Use - Part 2: Particular Requirements for Home Care Ventilators
This part of ISO 10651 is one of a series of International Standards based on IEC 601-1:1988 (the "General Standard"): this type of International Standard is referred to as a "Particular Standard"....
March 1, 1999
Lung Ventilators for Medical Use - Part 2: Particular Requirements for Home Care Ventilators
NOTE - See the rationale in annex M. This part of ISO 10651 is one of a series of International Standards based on IEC 601-1:1988 (the "General Standard"): this type of International Standard is...

References

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