ASTM_F_1628_-_95_2000.pdf

Designation:F 1628 95(Reapproved 2000)Standard Specification forLabeling and Marking of Cuffed and Uncuffed TrachealTubes and Related Treatments Intended for Use DuringLaser Surgery1This standard is issued under the fixed designation F 1628;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.1.Scope1.1 This specification covers the labeling,marking,warn-ings,and precautions for cuffed and uncuffed tracheal tubesand related materials intended by the manufacturer for useduring laser surgery of the airway.1.2 Rationale for this specification is to provide a standardformat for reporting results obtained from Test Method F 1497.Safety and performance tests,with availability of results,aredescribed in this specification to allow a manufacturer themaximum use of technological alternatives in design andmaterials.This specification addresses the laser resistance ofthe shaft of the tracheal tubes.Other components of the system,such as the inflation system and cuff,are outside the scope ofthis specification.1.3 The values stated in SI units are to be regarded asstandard.2.Referenced Documents2.1 ASTM Standards:F 1242 Specification for Cuffed and Uncuffed TrachealTubes2F 1497 Test Method for Determining the Laser Resistanceof the Shaft of Tracheal Tubes33.Terminology3.1 DefinitionsFor definitions other than those listed be-low refer to Specification F 1242 and Test Method F 1497.3.1.1 devicea tracheal tube or tracheal tube treatmentmaterial.3.1.2 markinginformation permanently affixed by themanufacturer to any surface of a tracheal tube or to any appliedcomponent of a laser resistant tracheal tube treatment that isaffixed to or protects the component up to the point it is appliedto the tracheal tube.3.1.3 productcommercially available device in its pack-aged and labeled form.3.1.4 tracheal tubea tube to convey gases or vapors to andfrom the trachea.This term shall be used rather than synonymssuch as“endotracheal,”“intratracheal,”or“catheter.”3.1.4.1 laser resistant tracheal tubea tracheal tube that isintended by the manufacturer for use during laser surgery.Thisincludes devices that are sold pre-assembled,or in kit form.3.1.5 laser resistant tracheal tube treatments coverings orsurface treatment materials,or both,indicated by the manufac-turer for use with standard tracheal tubes where this product isintended to adapt the standard tracheal tube for use in lasersurgery.3.1.5.1 DiscussionThis definition does not include suchmaterials when provided in kit form with the tracheal tube(see3.1.4.1).3.1.6 tracheal tube cuffan inflatable sleeve fastened to thepatient end of the tracheal tube to provide an effective,leak-resistant fit between the tube and the trachea.3.1.7 upper airwaythe segment of the anatomical airwayabove the laryngotracheal junction.4.Product Marking and Labeling4.1 All values shall be in SI units.4.2 Marking on the Device Shall Include:4.2.1 The name or trademark of the manufacturer or sup-plier.4.2.2 Model or formulation code that is necessary to distin-guish similar products from the same manufacturer,where thisdistinction is relevant to the laser resistance of the product.4.2.3 A reference to any preparation steps designated by themanufacturer as essential to the laser resistance of the trachealtube(that is,saturate covering with saline solution).4.2.4 For cuffed tracheal tubes,a reference shall be includedto any preparation steps designated by the manufacturer asessential for protection of the cuff from ignition(that is,inflatecuff with saline or water).4.2.5 Depth markings are optional.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is under the direct responsibility ofSubcommittee F29.18 on Operating Room Fire Safety.Current edition approved Sept.10,1995.Published November 1995.2Discontinued;See 2001 Annual Book of ASTM Standards,Vol 13.01.3Annual Book of ASTM Standards,Vol 13.01.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.4.2.5.1 Caution:When markings on the device are appliedto an area of the shaft considered to be laser resistant,thedetermination of laser resistance by the manufacturer mustinclude testing of the shaft directly upon these markings.4.3 Labeling on the Unit of Use Package:4.3.1 The following information shall be included in prod-uct labeling on product container.This information is supple-mental to other descriptive labeling regulated by applicablestandards,and is not intended to replace said labeling.4.3.1.1 A description of the package contents.4.3.1.2 The name or trademark of the manufacturer orsupplier.4.3.1.3 The product code or catalog number.4.3.1.4 A reference to the batch,lot,or control number.4.3.1.5 The word“