ASTM_F_1666_-_95e1.pdf

Designation:F 1666 95e1An American National StandardStandard Specification forAdult Tracheostomy Tubes1This standard is issued under the fixed designation F 1666;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 change was made to the title in October 1999.1.Scope1.1 This specification describes basic requirements for tra-cheostomy tubes made of plastic materials or rubber,or both;having inside diameters greater than 5.0 mm.Such tubes areprimarily designed for adult patients who may require anes-thesia,artificial ventilation,or other respiratory support,butneed not be restricted to these uses.Specialized tubes areexcluded from the scope of this specification.2.Referenced Documents2.1 The following standards contain provisions which,through reference in this text,constitute provisions of thisstandard.All standards are subject to revision,and parties toagreements based on this specification are encouraged toinvestigate the possibility of applying the most recent editionsof the standards indicated below.2.2 ASTM Standards:F 640 Test Methods for Radiopacity of Plastics for MedicalUse2F 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices2F 1054 Specification for Conical Fittings of 15 mm and 22mm sizes2F 1242 Specification for Cuffed and Uncuffed TrachealTubes22.3ISO Standards:ISO 4135 AnesthesiologyVocabulary3ISO 5366-1 Tracheostomy TubesPart 1:Connectors3ISO 7000 Graphical Symbols for Use on EquipmentIndex and Synopsis32.4ANSI Standard:ANSI/HIMA MD70.1 Medical MaterialLeur FittingsPerformance33.Terminology3.1 Definitions:3.1.1 angle of bevelacute angle between the plane of thebevel and the longitudinal axis of the tracheostomy tube at thepatient end.(See Angle B in Fig.1.)3.1.2 bevelslanted portion at the patient end of the tra-cheostomy tube.3.1.3 center-line lengthdistance from the patient side ofthe neck-plate to the patient end of the outer tube along thecenter line.3.1.4 cuffinflatable balloon fitted near the patient end ofthe tracheostomy tube to provide a leak-resistant seal betweenthe tube and the trachea.3.1.5 inflating tubetube through which the cuff is inflated.3.1.6 inner tubetube that fits closely to the inside contoursof the outer tube(tracheostomy tube).3.1.7 introducer(obturator)specifically adapted stylet tofacilitate the introduction of the outer tube into the trachea.3.1.8 machine endthat end of the tracheostomy tubewhich is intended to project from the patient.3.1.9 neck-plate(shield)that part of the tracheostomytube which approximates to the contour of the patients neckand is used to secure the tube in position.3.1.10 outer tubethat part of the tracheostomy tube whichis normally in contact with the tissues.3.1.11 patient endthat end of the tracheostomy tubewhich is intended to be inserted into the trachea.3.1.12 pilot balloonballoon fitted to the inflating tube toindicate inflation status of the cuff.3.1.13 tracheostomy(tracheotomy)tubetube designed forinsertion into the trachea through a tracheostomy.4.Materials and Manufacture4.1 Tracheostomy tubes,including cuffs,in their ready-for-use state shall be compatible with the human tissues withwhich they are intended to be used.Compatibility shall beindicated by the implantation test given in Annex A1,a celltissue culture test(see Practice F 813)or other tests that give anequivalent indication of freedom from biological hazard.NOTE1See Annex A3 for guidance on materials and design.5.Size and Dimensions5.1 Designation of Tube Size:5.1.1 The size designation of a single tracheostomy tube(no1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is under the direct responsibility ofSubcommittee F29.12 on Airways.Current edition approved Nov.10,1995.Published May 1996.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute,11 W.42nd St.,13thFloor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.NOTICE:This standard has either been superceded and replaced by a new version or discontinued.Contact ASTM International(www.astm.org)for the latest information.inner cannula)shall be the nominal inside diameter(ID)of thetube expressed in millimetres,as measured at the minimumdiameter,in accordance with Table 1,excluding any encroach-ment allowed by 6.5.1.5.1.2 The size designation of a tracheostomy tube with innercannula shall be indicated by both the nominal inner diameter(ID)of the outer tube and the inner diameter(ID)of the innertube expressed in millimetres.The two numbers shall bejuxtaposed by a slash or by a hyphen(example:8/7 or 87).5.2 Outside Diameter:5.2.1 The outside diameter(OD)of se