ASTM_F_1242_-_96e1.pdf

Designation:F 1242 96e1Standard Specification forCuffed and Uncuffed Tracheal Tubes1This standard is issued under the fixed designation F 1242;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.e1NOTEEditorial changes were made May 1997.1.Scope1.1 This specification covers the dimensions,rationale,labeling specifications,selected performance requirements,andtest methods of cuffed and uncuffed Magill and Murphy-typetracheal tubes.These tubes are commonly used as airwaycatheters in human patients in the practice of anesthesiologyand in respiratory care.This specification represents the state ofthe art at the time of publication and will be subject to periodicreview.1.2 This specification also provides test protocols to assessthe performance and safety of cuffed oral and nasal trachealtubes for prolonged use.Supporting rationale for the require-ments is provided inAppendix X1,and references are included.Required safety and performance tests,together with availabil-ity of results,are relied upon in this specification,wheneverpossible,to allow a manufacturer the maximum use of tech-nological alternatives in design and materials.1.3 The values stated in SI units are to be regarded asstandard.1.4 The following precautionary caveat pertains to the testmethod portions,Annex A1 and Appendix X2,of this specifi-cation: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.1.5 The following is a list of subject headings and subhead-ings included in this specification and the sections in whichthey appear:SectionsScope1Referenced Documents2Terminology3Materials4Inertness4.1SectionsSurface Characteristics4.2Rigidity4.3Integrity of Lumen4.4Requirements for Tubes With Cuffs5Cuffs5.1Cuff Pressure,Volume,and Diameter Characteristics5.2Inflation System5.3Dimensions,and Permissible Variations of Tracheal Tubes6Measurement System6.1Size and Dimensions6.2Radius of Curvature6.3Bevel6.4Murphy Eye6.5Product Marking7Marking Materials7.1Tracheal Tube Markings7.2Required Markings7.3Packaging and Labeling8Gas Effects8.1Sterile Tubes8.2Nonsterile Tubes8.3Disposable Tubes8.4Reusable Tracheal Tubes8.5Storage Conditions8.6TablesTracheal Tube DimensionsTable 1Dimensions of Cuffed Tracheal TubesTable 2FiguresTracheal TubeFig.1Cuffed Tracheal TubeFig.2Typical Murphy TipsFig.3Rationale for RequirementsAppendix X1Test MethodsAnnex A1Implantation TestA1.1Tube CollapseA1.2Cuff SymmetryA1.3Cuff HerniationA1.4Cuff Pressure,Volume,and Diameter Assessment;andTube Lumen ClosureA1.5Radiopaque MarkersA1.6Leak TestA1.7Determination of Test Inflation PressureTable A1.1Test for Tube CollapseFig.A1.1Test RigFig.A1.2Visual Inspection of Tube CuffFig.A1.3Cuff Herniation TestFig.A1.4Clear Polyvinyl Chloride Adult Model TracheaFig.X2.2Schematic of Cuffed Tracheal Tube in Model TracheaMounted Vertically in Test ApparatusFig.X2.1Discontinued Test ProtocolsAppendix X2Test Protocol OneTracheal Seal,Slope Pressure,andLumen Closure ConditionsX2.1Test Protocol TwoAbility to Conform to Human Anatomyand Resistance to KinkingX2.3Coordinates for Positioning Pegs on Test BoardTable X2.1Test BoardFig.X2.31This specification is under the jurisdiction of ASTM Committee F-29 onAnesthetic and Respiratory Equipmentand is the direct responsibility of Subcom-mittee F29.12 on Airways.Current edition approved Feb.10,1996.Published June 1996.Originallypublished as F 1242 89.Last previous edition F 1242 89.This specification,which is a consolidation and revision of ANSI Z79.14-1983and ANSI Z79.16-1983,supersedes these older standards.No attempt has beenmade to delineate all types of tracheal tubes.This specification is not intended toinhibit innovation,variation,and future development.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.NOTICE:This standard has either been superseded and replaced by a new version or discontinued.Contact ASTM International(www.astm.org)for the latest information.2.Referenced Documents2.1 ASTM Standards:NOTE1This specification is intended to be used in conjunction withthe following standards.When the standards referred to in this specifica-tion are superseded by an approved revision,the revision shall apply.F 640 Test Methods for Radiopacity of Plastics for MedicalUse2F 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices22.2ANSI Standards:3ANSI/HIMA MD70.1-1983 American National Standardfor Medical MaterialLuer Taper FittingsPerformanceANSI Z79.14-1983 American National Standard For Anes-thetic EquipmentTracheal TubesANSI Z79.16-198