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ASTM F1161 – Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines (Withdrawn 2000)

1.1 This specification covers the minimum performance and safety requirements to be used in the design of anesthesia gas machines for human use in order to enhance safety of the patient and operator. Intermittent-flow machines, which only deliver gas to the breathing system at varying rates in response to the patient’s inspiratory efforts, draw-over vaporizers, and dental nitrous oxide-oxygen analgesia machines are not covered in this standard.

1.2 This standard supercedes ANSI Z79.8-1979. The sections in ANSI Z79.8-1979 covering Flowmeter-Controlled and Electrically-Heated Vaporizers have been omitted since they are no longer manufactured in the U.S.

1.3 This specification is based in part on actual user experience (see Appendix X1) and on relevant portions of MIL-STD-1472C (see Appendix X2).

1.4 Qualification test procedures to determine compliance with the requirements are also specified. Equivalent qualification test procedures to determine compliance with these requirements may be used. Correlation of paragraph numbering has been maintained between the subsections on requirements and the subsections containing the corresponding test procedures to enable the appropriate test to be easily located (for example, the test for the requirement stated in 5.1.1 is in 5.2.1, the test for the requirement stated in 7.1.4 is in 7.2.4, and so on).

1.5 The following safety hazards caveat pertains only to the test methods described in 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.

1.6 This specification is arranged as follows:

Section Scope 1 Referenced Documents 2 Definitions 3 General 4 Requirements 4.1 Test Procedures and Equipment 4.2 Hanger Yokes 5 Requirements 5.1 Test Procedures 5.2 Pressure Gauges (Pressure Indicators) 6 Requirements 6.1 Test Procedures 6.2 Pressure Regulators 7 Requirements 7.1 Test Procedures 7.2 Gas Machine Piping 8 Requirements 8.1 Test Procedures 8.2 Flow-Control Systems 9 Requirements 9.1 Test Procedures 9.2 Oxygen Flush Valves 10 Requirements 10.1 Test Procedures 10.2 Flowmeters 11 Requirements 11.1 Test Procedures 11.2 Concentration-Calibrated Vaporizers 12 Requirements 12.1 Test Procedures 12.2 Common Gas Outlet 13 Requirements 13.1 Test Procedures 13.2 Pipeline Inlet Connections 14 Requirements 14.1 Test Procedures 14.2 Gas Power Outlet for a Ventilator 15 Requirements 15.1 Test Procedures 15.2 Alarms 16 Requirements 16.1 High Priority Alarms 16.2 Medium Priority Alarms 16.3 Low Priority Alarms 16.4 Oxygen-Supply Precautions 17 Requirements 17.1 Test Procedures 17.2 Ventilatory Monitoring 18 Requirements 18.1 Test Procedures 18.2 Tables Identifying Colors of Medical Gas Cylinders and their Contents (Volume) when Full 1 Alarms 2 Figures 23-mm Plug and Ring Gages 1 Profile of Oxygen Flow-Control Knob 2 Rigid Conical Fittings of 23-mm Size 3 Components for Screw-Threaded Weight-Bearing Fittings 4 Appendixes Rationale for Requirements X1 Sample Pre-use Check Lists Figs. X1.1, X1.2 Flowmeter Markings Table X1.1 Human Engineering Design Criteria X2 Lines of Sight Fig. X2.1 Vertical and Horizontal Visual Field Fig. X2.2 Application of Various Types of Mechanical Displays Table X2.1 Notes on Materials X3 Derivation of Formula for Forward Flow (Q) Through a Regulator X4