ASTM_F_1497_-_99a.pdf

Designation:F 1497 99aStandard Test Method forDetermining Laser Resistance of the Shaft of TrachealTubes1This standard is issued under the fixed designation F 1497;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.INTRODUCTIONSurgery in the airway in which a laser is used brings together an oxygen-enriched atmosphere,fuel,and high energy that can combine to create a fire.Various materials and devices have been used tominimize the chance of airway fire.This test method was developed to determine the laser resistanceof a tracheal tube shaft for a defined set of conditions.1.Scope1.1 This test method covers a standard means of testing thelaser resistance of the shaft of a tracheal tube.1.2 This test method addresses the laser resistance of theshaft of the tracheal tube.Other components of the system,such as the inflation system and cuff,are outside the scope ofthis test method.1.3 Caution should be observed since the direct applicabilityof the results of this test method to the clinical situation has notbeen fully established.1.4 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.1.5 This test method should be used to measure and describethe properties of materials,products,or assemblies in responseto heat and flame under controlled laboratory conditions andshould not be used to describe or appraise the fire hazard orfire risk of materials,products,or assemblies under actual fireconditions.However,results of this test may be used aselements of a fire risk assessment that takes into account all ofthe factors that are pertinent to an assessment of the fire hazardof a particular end use.1.6 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.Specific precau-tionary statements are given in Notes 1-6.2.Referenced Documents2.1 ASTM Standards:F 1242 Specification for Cuffed and Uncuffed TrachealTubes22.2ANSI Standards:ANSI Z136.1 American National Standard for the Safe Useof Lasers-19933ANSI Z136.3 American National Standard for the Safe Useof Lasers in Health Care Facilities-199632.3 CGA Standard:CGA G-4.3 Commodity Specification for Oxygen4CGA G-10.1 Commodity Specification for Nitrogen43.Terminology3.1 Definitions:3.1.1 blemishany apparent physical change to the shaft ofthe tracheal tube,other than damage or burning.Some ex-amples of blemish are discoloration,surface pitting,and minordeformation.3.1.2 burningany continuing combustion process that oc-curs in or on the test specimen.Some signs of burning areflame,smoldering,and rapid evolution of smoke.3.1.3 damageany physical change(for example,localheating,melting,creation of holes,ashing without burning,pyrolysis),other than burning,that may affect the safety of thepatient or efficacy of the shaft of the tracheal tube.3.1.4 laser resistancethe relative ability of a material towithstand laser energy without burning or damage.3.1.5 power densitythe rate at which laser energy isdelivered per unit area of irradiated surface,given in watts persquare centimetre(W/cm2).3.1.6 shaftthe portion of the tracheal tube between thecuff and the machine end of the tube.1This test method is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.18 on Operating Room Fire Safety.Current edition approved November 10,1999.Published December 1999.Originally published as F 1497-94.Last previous edition F 1497-99.2Discontinued;See 2001 Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.4Available from Compressed Gas Association,1235 Jefferson Davis Highway,Arlington,VA 22202.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.4.Summary of Test Method4.1 The shaft of a tracheal tube will be exposed to laserenergy of known characteristics while in an environment of 986 2%oxygen.NOTE1This test method can result in a rocket-like fire involving thetracheal tube.This fire can produce high heat,intense light,and toxicgases.5.Significance and Use5.1 This test method determines a uniform and repeatablemeasurement of the laser resistance of the shaft of a trachealtube.Most of the variables involved in laser ignition of atracheal tube have been fixed in order to establish a basis forcomparison.This measurement can be used to compare tra-cheal tubes having differing designs of laser protection.5.2 There are a large number and range of variable