CAN/CSA-Z10651-6-06 (R2015)
Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 6: Home-Care Ventilatory Support Devices (Adopted ISO 10651-6:2004, first edition, 2004-07-01, with Canadian deviations)
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CSA Preface
This is the first edition of CAN/CSA-Z10651-6, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10651-6 (first edition, 2004-07-01).
Scope
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required.
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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