LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT 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 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).