ASTM F1161 PDF

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Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines (Withdrawn 2000)

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Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines (Withdrawn 2000)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:

SectionScope1 Referenced Documents 2 Definitions3 General4 Requirements 4.1 Test Procedures and Equipment4.2 Hanger Yokes 5 Requirements 5.1 Test Procedures5.2 Pressure Gauges (Pressure Indicators)6 Requirements 6.1 Test Procedures6.2 Pressure Regulators7 Requirements 7.1 Test Procedures7.2 Gas Machine Piping 8 Requirements 8.1 Test Procedures8.2 Flow-Control Systems 9 Requirements 9.1 Test Procedures9.2 Oxygen Flush Valves 10 Requirements10.1 Test Procedures 10.2 Flowmeters11 Requirements11.1 Test Procedures 11.2 Concentration-Calibrated Vaporizers 12 Requirements12.1 Test Procedures 12.2 Common Gas Outlet 13 Requirements13.1 Test Procedures 13.2 Pipeline Inlet Connections14 Requirements14.1 Test Procedures 14.2 Gas Power Outlet for a Ventilator 15 Requirements15.1 Test Procedures 15.2 Alarms16 Requirements 16.1 High Priority Alarms16.2 Medium Priority Alarms16.3 Low Priority Alarms 16.4 Oxygen-Supply Precautions 17 Requirements17.1 Test Procedures 17.2 Ventilatory Monitoring18 Requirements18.1 Test Procedures 18.2TablesIdentifying Colors of Medical Gas Cylinders and their Contents (Volume) when Full1 Alarms 2 Figures23-mm Plug and Ring Gages1 Profile of Oxygen Flow-Control Knob2 Rigid Conical Fittings of 23-mm Size 3 Components for Screw-Threaded Weight-Bearing Fittings4 AppendixesRationale for Requirements X1 Sample Pre-use Check ListsFigs. X1.1, X1.2 Flowmeter MarkingsTable X1.1 Human Engineering Design CriteriaX2 Lines of SightFig. X2.1 Vertical and Horizontal Visual FieldFig. 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 RegulatorX4