1、Designation:F 1627 95An American National StandardStandard Specification forTracheostomy TubesPediatric Tracheostomy Tubes1This standard is issued under the fixed designation F 1627;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the
2、 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.INTRODUCTIONPediatric tracheostomy tubes are primarily intended for use with infants and children who mayrequire anesthesia,
3、artificial ventilation,relief of upper airway obstruction,or other respiratory therapy.An infant or child differs from an adult,not only in size but especially with regard to airwayanatomy and respiratory physiology.Airway equipment for pediatric patients involves differences notonly of size but als
4、o of basic design.The differences created a demand for a separate standard fortracheostomy tubes for pediatric use.It should be noted that,although this standard specifies somerequirements for cuffs,cuffs are seldom provided on the smaller sizes of pediatric tubes.This specification describes requir
5、ements for those characteristics of tracheostomy tubes that can bestandardized and that are important for patient safety.It does not,however,limit the variety of tubedesigns necessary to conform to pediatric anatomy and the variety of lesions and space limitationsencountered.A tracheostomy tube may
6、increase resistance to gas flow.For tubes with a given outside diameter,differences in wall thickness have a major influence on the resistance to gas flow,especially in thesmaller sizes of pediatric tracheostomy tubes.1.Scope1.1 This specification describes basic requirements for tra-cheostomy tubes
7、 made of plastic materials or rubber,or both,having inside diameters less than 6.0 mm.Such tubes areprimarily designed for pediatric patients who may requireanesthesia,artificial ventilation or other respiratory support,but need not be restricted to these uses.Specialized tubes areexcluded from the
8、scope of this specification.2.Referenced Documents2.1 ASTM Standards:F 640 Test Methods for Radiopacity of Plastics for MedicalUse2F 1054 Specification for Conical Fittings of 15 mm and 22mm Sizes2F 1242 Specification for Cuffed and Uncuffed TrachealTubes2F 1666 Specification for Adult Tracheostomy
9、Tubes2.2ISO Standards:3ISO 7000 Graphical SymbolsSynopsisANSI/HEMA MD 70.1-Conical Fittings3.Terminology3.1 DefinitionsFor the purpose of this specification,thedefinitions given in Specification F 1666,together with thefollowing definition,apply.3.2 pediatric tracheostomy tubetube designed for inser
10、-tion into the trachea of an infant or child through a tracheo-stomy.4.Size and Dimensions4.1 Designation of Tube Size:4.1.1 The size of a tracheostomy tube(outer tube)shall bedesigned by the nominal inside diameter(ID)of the tubeexpressed in millimetres,as measured at the minimum diam-eter,in accor
11、dance with Table 1,excluding any encroachmentallowed by 6.6.1.When the ID of the tracheostomy(outer)tubedoes not fall within specified limits of the categories listed inTable 1,the actual ID may be used as the size designation withappropriate tolerances.4.1.2 The size of a pediatric tracheostomy tub
12、e with innercannula shall be designated in accordance with SpecificationF 1666.4.2 Outside Diameter:4.2.1 The outside diameter(OD)of sections A and B(seeFig.1)of the tube,other than at the cuff if provided,shall be1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and R
13、espiratory Equipment and is under the direct responsibility ofSubcommittee F29.12 on Airways.Current edition approved Sept.10,1995.Published December 1995.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.1C
14、opyright 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.expressed in millimetres,subjec
15、t to a tolerance of 60.20 mm.Section C of the outer tube shall have a tolerance of 60.50mm.NOTE1The marked outside diameter relates to that portion of thetube intended to be within the wall and lumen of the trachea.4.3 Length:4.3.1 The center-line length(dimensionA+B+C in Fig.1)shall extend from the
16、 patient side of the neck-plate to thepatient end of the outer tube including to the tip of the bevel,if present(see Fig.2 Fig.insert)and expressed in millimetres.4.3.2 The actual center-line length shall not vary by morethan 1.5 mm from the marked length for tubes with a markedinside diameter of less than 4.5 mm,or by more than 2 mm fortubes with a marked inside diameter of 4.5 mm or greater.4.3.3 Dimensions A,B and C shall be expressed in milli-metres.NOTE2Dimensions A or B,or both,may be,or a