Scope
1.1 General -This specification establishes minimum performance and safety requirements for all ventilators and ventilator circuits intended for use with adult, child, or infant patients in critical care within the hospital and introduced for sale after the acceptance date of this specification, except as noted below. Definitions, performance requirements, test methods, and rationale are included. Several definitions have been included in Section 3.1 and Appendix X1 that are not used in the text of this specification. This material has been included for the sake of completeness, and for any possible educational benefit that may be served.
1.2 Exclusions -This specification does not apply to body ventilators such as the tank ventilator or the chest cuirass nor does it apply to ventilators utilizing the Sanders technique or "jet" ventilation, (venturi effect type) high frequency ventilators (greater than 2.5 Hz), or anesthesia ventilators. This specification does not apply to ventilators intended for use in transport applications or home care, nor does it apply to those ventilators developed for veterinary applications. The application of critical care ventilators in the home environment is not covered by this specification nor is the hospital use of transport or home care ventilators. (See also Appendix X2.1.)
1.3 The following precautionary caveat pertains to the test methods portion only, Section 6, of this specification: This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
