Abstract
This specification covers definitions, performance requirements, test methods, and a rationale for all mandatory requirements for ventilators intended for use during the administration of anesthesia. Requirements for sterilization or decontamination or both of all components of the ventilator are given. Performance requirements are specified for the following: (1) volume and wave-form, (2) ventilator endurance, (3) electrical and pneumatic power sources, (4) accuracy of calibrated working pressure control, indicators, and pressure relief device, (5) delivered volume, (6) accuracy of gas mixture controls, (7) expiratory resistance, (8) system internal compliance, (9) fittings connecting ventilator, ventilator circuit and spirometer, (10) mechanical stability and transportability, (11) ventilatory monitoring and alarms, (12) anesthetic gas pollution controls,and (13) controls and indicators. Lung models and the methods of testing performance of lung ventilators are detailed. Representative active and passive lung models are illustrated.
Scope
1.1 This specification applies to all ventilators specifically introduced for sale following acceptance of this specification and intended for use during the administration of anesthesia. Definitions, performance requirements, test methods, and a rationale for all mandatory requirements are included.
1.2 The anesthesia ventilator cannot protect against malfunctions within the anesthesia machine, nor can it protect against inappropriate or inadvertent use of the oxygen flush valve, and therefore, no attempt has been made to address problems that may arise from malfunctions with these devices in this specification. (See also X3.1.)
1.3 Several definitions have been included in Section 2 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. Appendix X1 also outlines various characteristics of ventilators intended for use during anesthesia and defines the main classes of breathing machines that may be used in medical practice and indicates how these may be subdivided according to their mode of action.
1.4 The following precautionary caveat pertains to the test methods portion, 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 concerns 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. For an additional safety precaution, see 7.1.7.
