ASTM_F_1981_-_99.pdf

Designation:F 1981 99Standard Specification forSuction Catheters for Use in the Respiratory Tract1This standard is issued under the fixed designation F 1981;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.INTRODUCTIONThis specification provides dimensions and requirements for suction catheters for use in therespiratory tract.The basis of this specification is ISO 8836:1997.There are major differences in theaddition of mandatory suction catheter“eyes,”removal of color coding,and inclusion of closed circuitsuction catheters.Size is designated by outside diameter,which is important when selecting catheters,because of itsrelationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube(see Specifications F 927,F 1242,F 1627,and F 1666 for details of requirements for tracheal tubesand tracheostomy tubes).Requirements for suction catheters made of rubber have been deletedbecause they are no longer in general use.1.Scope1.1 This specification provides requirements for suctioncatheters intended for use in suction of the respiratory tract.1.2 Angled-tip suction catheters,for example,Coud cath-eters,and closed circuit suction catheters are not considered tobe specialized,and therefore,are included in this specification.Specialized suction devices are excluded from this specifica-tion.1.3 Flammability of suction catheters,for example if flam-mable anesthetics,electrosurgical units,or lasers are used,is awell-recognized hazard that is addressed by appropriate clini-cal management and is outside the scope of this specification.2.Referenced Documents2.1 ASTM Standards:F 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices2F 927 Specification for Pediatric Tracheostomy Tubes2F 1205 Specification for Anesthesia Breathing Tubes2F 1242 Specification for Cuffed and Uncuffed TrachealTubes2F 1627 Specification for Tracheostomy TubesPediatricTracheostomy Tubes2F 1666 Specification for Adult Tracheostomy Tubes22.2ISO Standards:ISO 7000 Graphical Symbols for Use on EquipmentIndex and Synopsis3ISO 88361997 Suction Catheters for Use in the Respira-tory Tract33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 adapter,nspecialized connector to establish func-tional continuity between otherwise disparate or incompatiblecomponents.3.1.2 closed circuit suction catheter,na suction catheterthat is encased in a flexible,collapsible sleeve attached to abreathing circuit connector and intended to permit airwaysuctioning while maintaining the integrity of the breathingcircuit.3.1.3 connector,nfitting to join together two or morecomponents.3.1.4 eye,nlateral aperture near the patient end of thecatheter.3.1.5 machine end,nend of the catheter intended to beconnected to a source of vacuum.3.1.6 patient end,nend of the catheter intended to beinserted into the patient.3.1.7 residual vacuum,nnegative pressure at the patientend of the suction catheter when the vacuum control device isin the relief position.3.1.8 shaft,nmain part of the catheter,which is ofuniform outside diameter.3.1.9 suction catheter,nflexible tube designed for intro-duction into a patient airway to remove material by suction.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.12 on Airways.Current edition approved May 10,1999.Published September 1999.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.1.10 terminal orifice,ncentral opening at the patientend of the suction catheter.3.1.11 tip,nthe patient end of a suction catheter.3.1.12 vacuum control device,nmeans provided at or nearthe machine end of a suction catheter to control the flow ofgases and entrained material.4.Material4.1 Suction catheters for use in the respiratory tract,in theirready-to-use state after any preparation for use recommendedby the manufacturer,shall satisfy appropriate biological safetytesting,as indicated in Specification F 813.NOTE1It is recommended that the shaft be colorless and eithertransparent or translucent.NOTE2The outside surface of the suction catheter should havecharacteristics,which would facilitate insertion through all types ofplastic,rubber,and metal oro-and naso-tracheal tubes,tracheostomytubes,and appropriate connectors.NOTE3Suction catheters,under normal conditions of use,should bereasonably resistant to deterioration by anesthetic vapors and gases inclinical concentrations.5.Size Designation and Dimensions5.1 Size DesignationThe size of suction cat