1.1

Scope

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 requirements are relevant to the ventilator under consideration.

This part of ISO 10651 has common requirements with IEC 601-2-12 (see annex P). It also includes requirements from ISO 10651-1.

The scope and object given in clause 1 of IEC 601-1:1988 apply with the following addition:

This part of ISO 10651 specifies requirements for lung ventilators intended mainly for home care use but which could be used elsewhere (in hospitals) for appropriate patients in locations where the use of a ventilator complying with ISO 10651-1 is not required.

Devices intended solely to augment the ventilation of spontaneously breathing patients are excluded from this part of ISO 10651, as are cuirass ventilators which apply negative pressure to the chest wall.

NOTE - Requirements for ventilators intended for anaesthetic application are given in ISO 8835-1.

This part of ISO 10651 does not cover operator-powered ventilators (i.e. manual resuscitators).

NOTE - In this Standard, ""shall"" indicates a mandatory requirement, ""should"" indicates a recommendation or that which is advised but not mandatory, and ""may"" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to Figures and Tables are considered to be a part of the figure or table and are written as mandatory requirements.

Canadian Deviations are included in this Standard.