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ISO 10651-2:2004 PDF

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

First page of standard ISO 10651-2:2004Open preview (PDF)Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients
Title (English):
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

Document status:
Withdrawn
Format:
Electronic (PDF)
Number of pages:
31
Publication date:
June 29, 2004
Edition:
ISO IS 10651 edition 2 version 1
ICS:
11.040.10
Description (English):

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.

Technical details

Technical committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
SKU
ISO 10651-2:2004

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