Designation:F1101–90(Reapproved2003)e1StandardSpecificationforVentilatorsIntendedforUseDuringAnesthesia1ThisstandardisissuedunderthefixeddesignationF1101;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.e1NOTE—Theprecautionnoteinparagraph7.1.7wasmovedintothetexteditoriallyinDecember2003.1.Scope1.1Thisspecificationappliestoallventilatorsspecificallyintroducedforsalefollowingacceptanceofthisspecificationandintendedforuseduringtheadministrationofanesthesia.Definitions,performancerequirements,testmethods,andarationaleforallmandatoryrequirementsareincluded.1.2Theanesthesiaventilatorcannotprotectagainstmal-functionswithintheanesthesiamachine,norcanitprotectagainstinappropriateorinadvertentuseoftheoxygenflushvalve,andtherefore,noattempthasbeenmadetoaddressproblemsthatmayarisefrommalfunctionswiththesedevicesinthisspecification.(SeealsoX3.1.)1.3SeveraldefinitionshavebeenincludedinSection2andAppendixX1thatarenotusedinthetextofthisspecification.Thismaterialhasbeenincludedforthesakeofcompleteness,andforanypossibleeducationalbenefitthatmaybeserved.AppendixX1alsooutlinesvariouscharacteristicsofventilatorsintendedforuseduringanesthesiaanddefinesthemainclassesofbreathingmachinesthatmaybeusedinmedicalpracticeandindicateshowthesemaybesubdividedaccordingtotheirmodeofaction.1.4Thefollowingprecautionarycaveatpertainstothetestmethodsportion,Section6ofthisspecification.Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcernsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.Foranadditionalsafetyprecaution,see7.1.7.2.ReferencedDocuments2.1ASTMStandards:2F1054SpecificationforConicalFittingsF1161Sp...
