Lung Ventilators for Medical Use - Part 3: Particular Requirements for Emergency and Transport Ventilators (Adopted ISO 10651-3:1997)
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This is the first edition of CSA Standard CAN/CSA-Z10651-3, Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators, which is an adoption, with Canadian deviations, of the identically titled IS0 (International Organization for Standardization) Standard 10651 -3:1997 (first edition, 1997-01 -1 5). It is one of a series of CSA Standards addressing lung ventilators, including anaesthesia, critical care, home care, and neonatal ventilators.
Clause 1.2 on Normative References lists Canadian National Standards that are based on their international equivalents, and for which Canadian deviations have been identified. The requirements of these Standards take precedence over the International Standards on which they are based, so that any reference in IS0 10651-3:1997 to the International Standard shall be replaced with the equivalent Canadian Standard.
This Standard was reviewed for Canadian adoption by the Working Group on Transport Ventilators and the Subcommittee on Respiratory Technology under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment, and the Strategic Steering Committee on Health Care Technology. It was approved by the Technical Committee. A list of the members of these Committees is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
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 referred to as a Particular Standard. As stated in 1.3 of IEC 601-1:1988, the requirements of this part of ISO 10651 take precedence over those of IEC 601- 1:1988. Where this part of ISO 10651 specifies that a clause of IEC 601-1 applies, it means that the clause applies only if the requirement is relevant to the ventilator under consideration.
This part of ISO 10651 has common requirements with IEC 601-2- 12. It also includes requirements from ISO 10651-1:1993.
The scope and object given in clause 1 of IEC 601-1:1988 apply, except that 1.1 shall be replaced by the following:
This part of ISO 10651 specifies requirements for portable lung v entilators designed for use in emergency situations and transport. Emergency and transport ventilators, called hereafter ventilator, are often installed in ambulances or other types of rescue vehicles, but are often used outside this environment, where they have to be carried by the operator or other persons. These devices will frequently be used outside the hospital or home by personnel with different levels of training. This part of ISO 10651 is also applicable to devices permanently mounted in ambulances or aircraft.
This part of ISO 10651 does not cover operator-powered ventilators (ie. manual resuscitators).