ASTM_F_1208_-_89_2005.pdf

Designation:F 1208 89(Reapproved 2005)Standard Specification forMinimum Performance and Safety Requirements forAnesthesia Breathing Systems1This standard is issued under the fixed designation F 1208;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers breathing systems and compo-nents employed with anesthesia gas machines for humans.Thisspecification considers the circle system as a whole and someof its components individually.A particular emphasis is placedupon component arrangement in the circle absorber-type sys-tem,and submits a system of standard description and notation.Excluded are ventilators for use during anesthesia,Mapelsonnonrebreathing type systems,as well as breathing systems andrelated components of dental analgesia machines.(For ratio-nale,see Appendix X1.)1.2 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.3 This specification is arranged as follows:SectionScope1Referenced Documents2Terminology3System Classification4Graphic NotationsDiagramatic RulesFunctional Segments of the Circle SystemTest ProceduresGeneral5Sterilization6Systems7Leakage of Breathing SystemResistance of Breathing SystemsVolume of Gas Not Delivered to Patient Due to InternalComplianceMonitoring RequirementsAdjustable Pressure-Limiting(APL)Valves8Reservoir Bags9CO2Absorbers10Unidirectional Valves11RequirementsTest ProcedureOptional Components12Breathing Tubes13Fresh Gas Inlet and Fresh Gas Supply Tube or Hose14Connectors15Pressure Gauges16Y-Piece and Breathing Tubes17Information in Labeling18RationaleAppendix X12.Referenced Documents2.1 ASTM Standards:2F 1054 Specification for Conical Fittings3F 1204 Specification for Anesthesia Reservoir Bags3F 1205 Specification for Anesthesia Breathing Tubes2.2ANSI/ASME Standard:ANSI/ASME B40.1M-1985 Standard for Pressure Gauge43.Terminology3.1 Definitions:3.1.1 absorber assemblya container(s)for CO2absorbent,and may include,but need not be limited to,the inspiratory andexpiratory unidirectional valves,APL valve,and bag mount.3.1.2 adjustable pressure limiting valve(APL valve)auser-adjustable valve which releases gas and is intended toprovide control of the breathing system pressure.3.1.3 breathing systema gas pathway in direct connectionwith the patient through which gas flows occur at respiratory1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.10 on Anesthesia Workstations.Current edition approved May 1,2005.Published May 2005.Originallyapproved in 1989.Last previous edition approved in 2000 as F 1208 89(2000)e1.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Available from the American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.pressures,in which directional valves may be present,and intowhich a mixture of controlled composition may be dispensed.3.1.4 circle breathing systema breathing system in whichcircular gas flow(through separate inspiratory and expiratorypathways)is determined by unidirectional valves.3.1.5 common gas outletthat port through which themixture dispensed from the anesthesia gas machine is deliveredto the breathing system.3.1.6 compliancethe change of volume per unit change inpressure within a closed system.Units of compliance are:L/kPa or L/cm H2O(litres per kilopascal or litres per centime-tre of water).3.1.7 expiratory pathwaythat portion of the gas pathwaythrough which expired gases flow at respiratory pressures.3.1.8 fresh gas inletthat port on breathing systems towhich the fresh gas supply is attached.3.1.9 fresh gas supply tube(or hose)that conduit convey-ing gases from the common gas outlet,or other gas source,tothe fresh gas inlet of the breathing system.3.1.10 inspiratory pathwaythat portion of the gas path-way through which inspiratory gases flow at respiratorypressures.3.1.11 kilopascal(kPa)SI unit of pressure,1 kPa approxi-mates 10 cm of H2O.3.1.12 labelinginformation and literature accompanyingthe device(for example,brochure,package insert,manual,etc.).3.1.13 markinginformation directly on a device.3.1.14 maydenotes an optional feature or consideration.3.1.15 resistancethe pressure difference from inlet tooutlet