Z168.5.2-M1991

Scope

1.1
This Standard contains essential requirements for lung ventilators that function through a direct connection to the airway of a patient, providing controlled mechanical ventilation.

Note:
Other aspects should be described by the manufacturer's disclosure.

1.2
This Standard enumerates items necessary for ventilators to be classified by the term critical care, including requirements for the construction of critical care ventilators, for disclosure of their operating characteristics, for their marking, and for test procedures by which conformity to the requirements herein may be ensured.

1.3
This Standard addresses ventilators intended for applications for patient groups to be specified by the manufacturer. (See Clause 5.1.1(a).)

1.4
This Standard outlines requirements for ventilators up to and including the point of connection to the breathing circuit.

1.5 Exclusions

1.5.1
This Standard does not include specific requirements for anaesthesia ventilator equipment. (See CSA Standard CAN/CSA-Z168.5.1.)

1.5.2
This Standard does not apply to body ventilators or negative-pressure ventilators such as the tank ventilator or the chest cuirass, nor does it apply to ventilators utilizing the Sanders technique or jet ventilation, neonatal ventilators, or high-frequency ventilators. As well, this Standard 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 Standard nor is the hospital use of transport or home care ventilators.

1.6
Values shown in parentheses are to be considered approximate conversions.