Abstract
This specification covers all electrically powered lung ventilators and ventilator circuits specifically intended for use in the home environment, breathing circuits intended specifically for use with home care ventilators are also included. The test methods for power source requirements; accuracy of controls, indicators, and pressure relief devices; human factor requirements; breathing circuit requirements; alarm requirements; and anti-asphyxia valve and negative pressure relief valves requirements are presented in details.
Scope
1.1 This specification covers all electrically powered lung ventilators and ventilator circuits specifically intended for use in the home environment, and marketed after the final date of approval for this specification. Breathing circuits intended specifically for use with home care ventilators are also included within the scope of this specification. The application of critical care ventilators, anesthesia ventilators, emergency care transport ventilators, and resuscitators in the home environment is not covered by this specification. As well, this specification does not cover high frequency ventilators or external body ventilators. Part 1 of this specification addresses positive pressure ventilators, and Part 2 addresses negative pressure ventilators. (See also X1.1.1.)
1.2 The values stated in SI units are to be regarded as standard.
1.3 The following precautionary caveat pertains to the test method 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.
